History
# Registration date Revision Id
2 2020-07-18, 1399/04/28 143683
1 2016-08-17, 1395/05/27 19867
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  • Protocol summary

    Our aim is the Comparison of the anesthetic efficacy of Articaine 4% as supplemental Intraligamentary injection with Buccal Infiltration in posterior mandibular teeth with irreversible pulpitis. 100 patients in Shahid Beheshti Endodontics ِDepartment will be participated in this study. All the patients should have first or second vital mandibular molar without spontanous pain and should have positive response to Electrical Pulp Tester and prolonged response to cold test. We will record patients pulses before the treatment. All the patients will receive Inferior Alveolar Nerve Block with 1.5 ml Lidocaine 2% with epinephrine 1/100000 and 0.3 ml long buccal injection with Lidocaine 2% with epinephrine 1/100000. After 15 minutes the patients without lip numbness will be excluded. The teeth will be examined by cold test and Electrical Pulp Tester and the patients indicate their pain on Heft Parker Visual Analogue Scale and the pain will be record like this in all stages. The pulse after the Inferior Alveolar Nerve Block injection will be recorded. If the Electrical Pulp Test number after this injection will be under 80 we will consider supplemental injection. All the injections will be done by one person. After 5 minutes the teeth will be examined by cold test and Electrical Pulp Tester and the patients will indicate their pain and the pulse will be recorded and the access cavity will be prepared and initial filing will be done. If the patients report moderate to severe pain during these procedures another anesthetic technique will be considered for them and will be reported as a failure. The patients will be classified randomly into 2 subgroups. In subgroup 1, 0.4 ml of the Intraligamentary injection with Articaine 4% with epinephrine 1/80000 and in subgroup 2, 1.8 ml of the Buccal Infiltration injection with Articaine 4% with epinephrine 1/80000 will be performed. Another person should fill the questionnaire, this person and the patients are blind to the injection technique.The success of 2 injections is considered to the ability for preparing the access cavity completely and initial filing without any pain or mild pain.
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    هدف ما بررسی میزان اثربخشی آرتیکایین 4% به عنوان تزریق مکمل اینترالیگامنتری درمقایسه با تزریق انفیلتراسیون باکال در دندان های مولرپایین با پولپیت برگشت ناپذیر است. 100 بيمار در بخش اندودنتيك دانشکده دندانپزشکی شهید بهشتی در مطالعه شرکت خواهند کرد. تمامي بيماران بايد داراي مولر اول یا دوم وایتال منديبل كه فاقد درد خودبه‌خودي هستند و پاسخ مثبت به الكتريكال پالپ تستر و پاسخ طولاني مدت به تست يخ نشان میدهند باشند. نبض بیماران قبل از کار اندازه گیری می شود. تمامی بيماران 1/5 میلی لیتر تزريق تنه ای آلوئولار عصب تحتانی ليدوكائين %2 با اپي‌نفرين یک صد هزارم و همچنین 0/3 میلی لیتر تزریق لانگ باکال با لیدوکایین 2% با اپی نفرین یک صد هزارم دريافت خواهند كرد. بعد از 15 دقیقه بیماران بدون بی حسی لب خارج خواهند شد. اين دندان‌ها با تست سرما و الکتریکال پالپ تستر مورد آزمایش قرار خواهند گرفت و بيماران درد خود را بر روي Heft Parker Visual Analogue Scale مشخص خواهند كرد و در تمامی مراحل, درد اینگونه ثبت خواهد شد. نبض بيماران ثبت خواهد شد. اگر عدد الکتریکال پالپ تستر بعد از این تزریق زیر 80 باشد تزریق مکمل در نظر خواهیم گرفت. تمام تزریقات توسط یک نفر انجام خواهد شد. 5 دقیقه بعد اين دندان‌ها با تست سرما و الکتریکال پالپ تستر مورد آزمايش قرار خواهند گرفت و بیماران درد خود را مشخص خواهند کرد و نبض بیمار ثبت می شود و حفره دسترسی آماده سازی شده و فایلینگ اولیه انجام می شود. اگربیمار درد متوسط تا شدیدی را حین این مراحل گزارش کند تكنيك بي‌حسي ديگري براي او در نظر گرفته خواهد شد و به عنوان شكست گزارش خواهد شد. بیماران به صورت تصادفی به 2 زیر گروه تقسیم می شوند. در زیر گروه 1, تزريق اینترالیگامنتری با آرتي‌كائين %4 همراه با اپي‌نفرين یک هشتاد هزارم با حجم 0/4 میلی لیتر و در زیر گروه 2, تزريق انفیلتراسیون باکال با آرتیکایین 4% با اپی نفرین یک هشتاد هزارم با حجم 1/8 میلی لیتر صورت خواهد گرفت. فرد دیگری باید پرسشنامه را پر کند، این فرد و بیماران نسبت به نوع تزریق کور خواهند بود. موفقيت تركيب دو تزريق به معناي توانايي برای كامل كردن حفره دسترسی و فایلینگ اولیه, بدون درد و يا درد كم خواهدبود.
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    Comparison of the anesthetic efficacy of articaine 4% as supplemental intraligamentary injection with buccal Infiltration in posterior mandibular teeth with irreversible pulpitis.
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    مقایسه میزان اثربخشی آرتیکایین 4% به عنوان تزریق مکمل داخل لیگامانی درمقایسه با تزریق انفیلتراسیون باکال در دندان های مولرپایین با پولپیت برگشت ناپذیر.
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    Prospective randomized clinical trial
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    مطاله بالینی آینده نگر تصادفی
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    All the patients will receive inferior alveolar nerve block(1.5ml) and long buccal(0.3 ml) injections of lidocaine 2% with epinephrine 1/100000. After 15 minutes the patients without lip numbness will be excluded. The teeth will be examined by cold test and electrical pulp tester and the patients indicate their pain on Heft Parker Visual Analogue Scale. The pulse will be recorded. If the electrical pulp test number will be under 80 we will consider supplemental injection. All the injections will be done by one person. After 5 minutes the teeth will be examined by cold test and electrical pulp tester and the patients will indicate their pain and the pulse will be recorded and the access cavity will be prepared and initial filing will be done. If the patients report moderate to severe pain during these procedures another anesthetic technique will be considered for them and will be reported as a failure
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    تمامی بيماران تزريق تنه ای آلوئولار عصب تحتانی(1.5میلی لیتر) ولانگ باکال(0.3 میلی لیتر) باليدوكائين %2 با اپي‌نفرين یک صد هزارم دريافت خواهند كرد. بعد از 15 دقیقه بیماران بدون بی حسی لب خارج خواهند شد. اين دندان‌ها با تست سرما و الکتریکال پالپ تستر مورد آزمایش قرار خواهند گرفت و بيماران درد خود را بر روي Heft Parker Visual Analogue Scale مشخص خواهند كرد. نبض بيماران ثبت خواهد شد. اگر عدد الکتریکال پالپ تستر زیر 80 باشد تزریق مکمل در نظر خواهیم گرفت. تمام تزریقات توسط یک نفر انجام خواهد شد. 5 دقیقه بعد اين دندان‌ها با تست سرما و الکتریکال پالپ تستر مورد آزمايش قرار خواهند گرفت و بیماران درد خود را مشخص خواهند کرد و نبض بیمار ثبت می شود و حفره دسترسی آماده سازی شده و فایلینگ اولیه انجام می شود. اگربیمار درد متوسط تا شدیدی را حین این مراحل گزارش کند تكنيك بي‌حسي ديگري براي او در نظر گرفته خواهد شد و به عنوان شكست گزارش خواهد شد.
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    One hundred patients in Endodontic ِDepartment, Scchool of Dentistry, Shahid Beheshti University of Medical Sciences. Patients with a first or second vital mandibular molar without spontanous pain,with positive response to electrical pulp tester and prolonged response to cold test.
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    صد بيمار در بخش اندودنتيك دانشکده دندانپزشکی شهید بهشتی. بيماران داراي مولر اول یا دوم وایتال منديبل فاقد درد خودبه‌خودي با پاسخ مثبت به الكتريكال پالپ تستر و پاسخ طولاني مدت به تست يخ.
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    Subgroup 1: 0.4 ml of the supplemental intraligamentary injection with articaine 4% with epinephrine 1/80000. Subgroup 2:1.8 ml of the supplemental buccal infiltration injection with articaine 4% with epinephrine 1/80000.
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    زیر گروه یک، تزريق مکمل داخل لیگامانی با آرتي‌كائين %4 همراه با اپي‌نفرين یک هشتاد هزارم با حجم 0/4 میلی لیتر. زیر گروه 2, تزريق مکمل انفیلتراسیون باکال با آرتیکایین 4% با اپی نفرین یک هشتاد هزارم با حجم 1/8 میلی لیتر.
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    The success of the injections was defined as the ability to prepare access cavity and initial filing with no or mild pain (0 or less than 54 mm on HP-VAS).
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    موفقيت تزريق ها به معناي توانايي برای كامل كردن حفره دسترسی و فایلینگ اولیه, بدون درد و يا درد كم خواهدبود(0 یا کمتر از54 میلی متر روی HP-VAS).
  • General information

    PDL: Periodontal ligament
    Double blinded
    Single blinded
    1
    1
    1
    N/A
    3
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    100
    2015-09-23, 1394/07/01
    2016-04-08, 1395/01/20
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    2016-10-23, 1395/08/02
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    2017-03-18, 1395/12/28
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    2017-03-18, 1395/12/28
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    To enter the actual recruitment start and end date.
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    با سلام وادب. به روز رسانی به علت پر کردن خانه های خالی و وارد کردن تاریخهای قطعی شروع و پایان بیمار گیری میباشد.
    Comparison of the anesthetic efficacy of Articaine 4% in two supplemental anesthetic injections
    Comparison of the anesthetic efficacy of articaine 4% in two supplemental anesthetic injections
    Comparison of the anesthetic efficacy of Articaine 4% as supplemental Intraligamentary injection with Buccal Infiltration in posterior mandibular teeth with irreversible pulpitis
    Comparison of the anesthetic efficacy of articaine 4% as supplemental intraligamentary injection with buccal infiltration in posterior mandibular teeth with irreversible pulpitis
    بررسی میزان اثربخشی آرتیکایین 4% به عنوان تزریق مکمل اینترالیگامنتری درمقایسه با تزریق انفیلتراسیون باکال در دندان های مولرپایین با پولپیت برگشت ناپذیر
    مقایسه میزان اثربخشی آرتیکایین 4% به عنوان تزریق مکمل داخل لیگامانی درمقایسه با تزریق انفیلتراسیون باکال در دندان های مولرپایین با پولپیت برگشت ناپذیر
    Patients older than 18 without any systemic diseases
    First or second mandibular molars with irreversible pulpitis
    No periapical lesion in radiography
    Prolonged response with moderate to severe pain to cold test and check the vitality by electrical pulp tester
    Vital coronal pulp tissue
    بيماران سالم از نظر بيماري‌هاي سيستميك بالاي 18 سال
    داشتن دندان اول و دوم مولر منديبل با پولپيت برگشت ناپذير
    عدم وجود ضايعه‌ پري‌اپيكال در راديوگرافي
    اثبات حیات دندان با استفاده از الکتریکال پالپ تستر و پاسخ طولاني‌ مدت به همراه درد متوسط تا شدید به تست سرما
    وجود پالپ كرونالي و زنده
    Allergy to lidocaine or articaine
    Lactate or pregnancy
    Using analgesic drugs since 12 hours before the treatment
    Mobility more than 0.5mm
    Probing more than 3mm
    Severe dental pain needs emergency treatment
    Teeth with full crowns
    No lip numbness after the Inferior Alveolar Nerve Block injection
    No pulp exposure after removing caries
    حساسيت به ليدوكائين يا آرتي‌كائين
    شيردهي و بارداري
    استفاده از داروهاي ضد درد 12 ساعت قبل از درمان
    موبیلیتی بيشتر از 0/5 میلی متر
    پروبينگ بيشتر از 3 میلی متر
    دندان با درد شديد كه نياز به درمان اورژانسي دارد
    دندان های دارای کراون کامل
    عدم بي‌حسي لب بعد از تزريق تنه ای عصب آلوئولار تحتانی
    عدم اکسپوژر پالپ بعد از برداشت پوسيدگي
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    Stratified permutations blocks randomization
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    تصادفی سازی طبقه بندی شده بلوکی
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    All injections are done by a single clinician. The principle investigator or outcome assessor is different from the operator who administers anesthesia and root canal therapy. So he is blind to anesthetic technique used. The patients and the clinician who administered anesthesia are not blind to anesthetic technique. The statistician who analyzed the data was blinded to the procedure.
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    تمام تزریقها توسط یک کلینیسین انجام میشود. محقق اصلی یا کسی که اوت کامها را اندازه گیری میکنداز فرد اپراتور که تزریق را انجام میدهدودرمان ریشه را انجام میدهدمتفاوت است. پس نسبت به تکنیک بی حسی کور میباشد. بیمار وکلینیسین نسبت به روش بی حسی کور نیستند.
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  • Health conditions studied

    #1
    irreversible pulpitis
    Irreversible pulpitis
  • Primary outcomes

    #1
    After Inferior alveolar Nerve Block injection, After supplemental injection
    After inferior alveolar nerve block injection, after supplemental injection
    Electrical Pulp Tester
    Electrical pulp tester
    #2
    Before Inferior Alveolar nerve Block injection, After Inferior alveolar nerve Block injection, After supplemental injection
    Before inferior alveolar nerve block injection, after inferior alveolar nerve block injection, after supplemental injection
    Pulse-Oximetre
    Pulse-oximetre
    #3
    During Inferior Alveolar Nerve Block and supplemental injection
    Pain during inferior alveolar nerve block and supplemental injection
    حین تزریق تنه ای عصب آلوئولار تحتانی و مکمل
    درد حین تزریق تنه ای عصب آلوئولار تحتانی و مکمل
    #4
    After Inferior Alveolar Nerve Block and supplemental injection
    After inferior alveolar nerve block and supplemental injection
  • Intervention groups

    #1
    After Inferior Alveolar Nerve Block injection with Lidocaine and Epinephrine 1/80000, the supplemental Buccal Infiltration injection with Articaine 4% and Epinephrine 1/100000 will be done
    After inferior alveolar nerve block injection with lidocaine and epinephrine 1/80000, the supplemental buccal infiltration injection with articaine 4% and epinephrine 1/100000 will be done
    #2
    After Inferior Alveolar Nerve Block injection with Lidocaine and Epinephrine 1/80000, the Intraligamentry injection with Articaine 4% and Epinephrine 1/100000 will be done
    After inferior alveolar nerve block injection with lidocaine and epinephrine 1/80000, the intraligamentry injection with articaine 4% and epinephrine 1/100000 will be done
  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid Beheshti University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی دانشگاه شهیدبهشتی
    Full name of responsible person - English: Nazanin Zargar
    Full name of responsible person - Persian: Nazanin Zargar
    Street address - English:
    Street address - Persian:
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Endodontic Department, School of Dentistry,Shahid Beheshti University of Medical Sciences
    Name of recruitment center - Persian: بخش اندودونتیکس دانشکده دندانپزشکی دانشگاه علوم پزشکی شهیدبهشتی
    Full name of responsible person - English: Nazanin Zargar
    Full name of responsible person - Persian: Nazanin Zargar
    Street address - English: School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Avenue, Shahid Chamran Highway, Tehran, Iran
    Street address - Persian: ایران، تهران، بزرگراه شهید چمران، خیابان اوین، بلوار دانشجو، دانشکده دندانپزشکی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1983969411
    Phone: +98 21 2240 3075
    Fax: +98 21 2240 3194
    Email: nzargar48@yahoo.com
    Web page address: http://www.dentistry.sbmu.ac.ir
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Shahid Behsehti University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهیدبهشتی
    Full name of responsible person - English: Dr. Zarghi
    Full name of responsible person - Persian: دکتر زرقی
    Street address - English: Dental school of Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
    Street address - Persian: ایران, تهران, بزرگ راه شهید چمران، خیابان اوین, بلوار دانشجو، دانشکده دندان پزشکی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shahid Behsehti University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهیدبهشتی
    Full name of responsible person - English: Dr. Zarghi
    Full name of responsible person - Persian: دکتر زرقی
    Street address - English: Dental school of Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
    Street address - Persian: ایران, تهران, بزرگ راه شهید چمران، خیابان اوین, بلوار دانشجو، دانشکده دندان پزشکی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1983963113
    Phone: +98 21 2240 3075
    Fax: +98 21 2240 3194
    Email: nzargar48@yahoo.com
    Web page address: http://www.dentistry.sbmu.ac.ir
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    Public
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    Domestic
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهیدبهشتی
    Full name of responsible person - English: Nazanin Zargar
    Full name of responsible person - Persian: نازنین زرگر
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Dental school of Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
    Street address - Persian: ایران, تهران, بزرگ راه شهید چمران، خیابان اوین, بلوار دانشجو، دانشکده دندان پزشکی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 2217 5350
    Mobile:
    Fax:
    Email: nzargar48@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهیدبهشتی
    Full name of responsible person - English: Nazanin Zargar
    Full name of responsible person - Persian: نازنین زرگر
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
    Street address - Persian: ایران, تهران, بزرگ راه شهید چمران، خیابان اوین, بلوار دانشجو، دانشکده دندان پزشکی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1983963113
    Phone: +98 21 2217 5350
    Mobile: +98 912 132 8143
    Fax: +98 21 2240 3194
    Email: nzargar48@yahoo.com
    Web page address: http://www.dentistry.sbmu.ac.ir
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهیدبهشتی
    Full name of responsible person - English: Nazanin Zargar
    Full name of responsible person - Persian: نازنین زرگر
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Dental school of Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
    Street address - Persian: ایران, تهران, بزرگ راه شهید چمران، خیابان اوین, بلوار دانشجو، دانشکده دندان پزشکی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 219121328143
    Mobile:
    Fax:
    Email: nzargar@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهیدبهشتی
    Full name of responsible person - English: Nazanin Zargar
    Full name of responsible person - Persian: نازنین زرگر
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
    Street address - Persian: ایران, تهران, بزرگ راه شهید چمران، خیابان اوین, بلوار دانشجو، دانشکده دندان پزشکی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1983963113
    Phone: +98 219121328143
    Mobile: +98 912 132 8143
    Fax: +98 21 2240 3194
    Email: nzargar@yahoo.com
    Web page address: http://www.dentistry.sbmu.ac.ir
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Nazanin Zargar
    Full name of responsible person - Persian: نازنین زرگر
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blv, Evin Avenue, Chamran Highway, Tehran, Iran
    Street address - Persian: ایران، تهران، بزرگراه شهید چمرانف خیابان اوین، بلوار دانشجو، دانشکده دندانپزشکی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 2217 5350
    Mobile: +98 912 132 8143
    Fax: +98 21 2240 3194
    Email: nzargar48@yahoo.com
    Web page address: http://www.dentistry.sbmu.ac.ir
  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Because the article has not been published yet.
    empty
    چون مقاله آن هنوز چاپ نشده است.

Protocol summary

Study aim
Comparison of the anesthetic efficacy of articaine 4% as supplemental intraligamentary injection with buccal Infiltration in posterior mandibular teeth with irreversible pulpitis.
Design
Prospective randomized clinical trial
Settings and conduct
All the patients will receive inferior alveolar nerve block(1.5ml) and long buccal(0.3 ml) injections of lidocaine 2% with epinephrine 1/100000. After 15 minutes the patients without lip numbness will be excluded. The teeth will be examined by cold test and electrical pulp tester and the patients indicate their pain on Heft Parker Visual Analogue Scale. The pulse will be recorded. If the electrical pulp test number will be under 80 we will consider supplemental injection. All the injections will be done by one person. After 5 minutes the teeth will be examined by cold test and electrical pulp tester and the patients will indicate their pain and the pulse will be recorded and the access cavity will be prepared and initial filing will be done. If the patients report moderate to severe pain during these procedures another anesthetic technique will be considered for them and will be reported as a failure
Participants/Inclusion and exclusion criteria
One hundred patients in Endodontic ِDepartment, Scchool of Dentistry, Shahid Beheshti University of Medical Sciences. Patients with a first or second vital mandibular molar without spontanous pain,with positive response to electrical pulp tester and prolonged response to cold test.
Intervention groups
Subgroup 1: 0.4 ml of the supplemental intraligamentary injection with articaine 4% with epinephrine 1/80000. Subgroup 2:1.8 ml of the supplemental buccal infiltration injection with articaine 4% with epinephrine 1/80000.
Main outcome variables
The success of the injections was defined as the ability to prepare access cavity and initial filing with no or mild pain (0 or less than 54 mm on HP-VAS).

General information

Reason for update
To enter the actual recruitment start and end date.
Acronym
IRCT registration information
IRCT registration number: IRCT2015072023253N1
Registration date: 2016-08-17, 1395/05/27
Registration timing: prospective

Last update: 2020-07-19, 1399/04/29
Update count: 1
Registration date
2016-08-17, 1395/05/27
Registrant information
Name
Nazanin Zargar
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3075
Email address
n.zargar48@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
2016-10-23, 1395/08/02
Actual recruitment end date
2017-03-18, 1395/12/28
Trial completion date
2017-03-18, 1395/12/28
Scientific title
Comparison of the anesthetic efficacy of articaine 4% as supplemental intraligamentary injection with buccal infiltration in posterior mandibular teeth with irreversible pulpitis
Public title
Comparison of the anesthetic efficacy of articaine 4% in two supplemental anesthetic injections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 without any systemic diseases First or second mandibular molars with irreversible pulpitis No periapical lesion in radiography Prolonged response with moderate to severe pain to cold test and check the vitality by electrical pulp tester Vital coronal pulp tissue
Exclusion criteria:
Allergy to lidocaine or articaine Lactate or pregnancy Using analgesic drugs since 12 hours before the treatment Mobility more than 0.5mm Probing more than 3mm Severe dental pain needs emergency treatment Teeth with full crowns No lip numbness after the Inferior Alveolar Nerve Block injection No pulp exposure after removing caries
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified permutations blocks randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
All injections are done by a single clinician. The principle investigator or outcome assessor is different from the operator who administers anesthesia and root canal therapy. So he is blind to anesthetic technique used. The patients and the clinician who administered anesthesia are not blind to anesthetic technique. The statistician who analyzed the data was blinded to the procedure.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Dental Research Center, Shahid Beheshti University of Medical Sciences
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.24

Health conditions studied

1

Description of health condition studied
Irreversible pulpitis
ICD-10 code
k04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
Anesthesia
Timepoint
After inferior alveolar nerve block injection, after supplemental injection
Method of measurement
Electrical pulp tester

2

Description
Pulse
Timepoint
Before inferior alveolar nerve block injection, after inferior alveolar nerve block injection, after supplemental injection
Method of measurement
Pulse-oximetre

3

Description
Pain during injection
Timepoint
Pain during inferior alveolar nerve block and supplemental injection
Method of measurement
Heft Parker Visual Analogue Scale

4

Description
Pain
Timepoint
After inferior alveolar nerve block and supplemental injection
Method of measurement
Heft Parker Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
After inferior alveolar nerve block injection with lidocaine and epinephrine 1/80000, the supplemental buccal infiltration injection with articaine 4% and epinephrine 1/100000 will be done
Category
Treatment - Other

2

Description
After inferior alveolar nerve block injection with lidocaine and epinephrine 1/80000, the intraligamentry injection with articaine 4% and epinephrine 1/100000 will be done
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Endodontic Department, School of Dentistry,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Zargar
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Avenue, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2240 3075
Fax
+98 21 2240 3194
Email
nzargar48@yahoo.com
Web page address
http://www.dentistry.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Behsehti University of Medical Sciences
Full name of responsible person
Dr. Zarghi
Street address
Dental school of Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Fax
+98 21 2240 3194
Email
nzargar48@yahoo.com
Web page address
http://www.dentistry.sbmu.ac.ir
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Behsehti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Zargar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5350
Fax
+98 21 2240 3194
Email
nzargar48@yahoo.com
Web page address
http://www.dentistry.sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Zargar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 219121328143
Fax
+98 21 2240 3194
Email
nzargar@yahoo.com
Web page address
http://www.dentistry.sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Zargar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blv, Evin Avenue, Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2217 5350
Fax
+98 21 2240 3194
Email
nzargar48@yahoo.com
Web page address
http://www.dentistry.sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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