History
# Registration date Revision Id
2 2017-12-13, 1396/09/22 32032
1 2016-05-12, 1395/02/23 21972
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  • Protocol summary

    This is a second or third phase, unicenter, prospective, parallel, double blind, randomized clinical trial. The aim of this study was to compare patient satisfaction with three types of denture occlusion. The sample size was 90 patients of the school of dentistry in Kermanshah university of medical sciences with the last tooth being extracted 3 month ago. Patients with mental problems and dissatisfied to keep on the study were removed. Patients were randomly allocated into 3 groups with stratified randomization method. In each group a set of complete dentures was made for each patient with an occlusal relation different from the other groups. The studied occlusions were: 1- bilateral balanced occlusion in which the most number of the teeth are in contact with all mandible movements, 2- lingualized occlusion in which just lingual cusps of maxillary teeth are the only ones in contact with the central fossa of mandibular teeth but the buccal cusps do not have any contact, 3- buccalized occlusion, the newfound occlusion in this study, in which just buccal cusps of mandibular teeth are in contact with the central fossa of maxillary teeth but the lingual cusps do not have any contact. After denture delivery and examinations after a day and a week, the satisfaction level of the patient was assessed at the end of month using a questionnaire.
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    این مطالعه کارآزمایی بالینی، تصادفی شده، دوسویه کور، موازی، جهت آن رو به جلو، تک مرکزی و در فاز دو یا سه میباشد. هدف از انجام این طرح مقایسه رضایت مندی بیماران از سه نوع اکلوژن در دنچر است. حجم نمونه، نود نفر از بیماران دانشکده دندانپزشکی کرمانشاه می باشد که حداقل تا سه ماه گذشته آخرین دندان های خود را کشیده اند. بیمارانی که دارای مشکلات روانی بوده یا حاضر به شرکت در ادامه مطالعه نباشند حذف میشوند. با استفاده از روش تصادفی سازی طبقه بندی شده بیماران به سه گروه تخصیص میابند. در هر گروه برای هر بیمار یک دست دندان مصنوعی با رابطه اکلوزالی یکسان در آن گروه که با دوگروه دیگر متفاوت است، ساخته می شود. اکلوژن های مورد مطالعه عبارتند از: 1- اکلوژن بالانس شده دوطرفه که در آن درتمام حرکات جانبی فک پایین حداکثر تعداد دندان ها درتماس باهم قرار می گیرند، 2- اکلوژن لینگوالی شده که در آن تنها کاسپ های پالاتال دندان های بالا با فوسای مرکزی دندان های پایین تماس دارند و کاسپ های باکال هیچ تماسی ندارند، 3- اکلوژن جدید این مطالعه، اکلوژن باکالی شده است که در آن تنها کاسپ های باکال دندان های پایین با فوسای مرکزی دندان های بالا تماس دارند. پس از تحویل دست دندان ها به بیماران وانجام معاینات یک روز بعد ویک هفته بعد، در پایان ماه با تکمیل پرسشنامه میزان رضایت بیماران از دنچرها بررسی می شود.
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    The aim of this study was to compare patient satisfaction with four types of denture occlusion.
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    هدف از انجام این طرح مقایسه رضایت مندی بیماران از چهار نوع اکلوژن در دنچر است.
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    En In this study, 120 patients edentulous and criteria of the study referred to dental school Kermanshah are selected . The participants were randomly selected. The test was carried out in Phase2-3.
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    در این مطالعه 120بیمار بی دندان کامل و دارای شرایط ورود به مطالعه که به دانشکده دندانپزشکی کرمانشاه مراجعه می کنند انتخاب می شوند.شرکت کنندگان به صورت تصادفی انتخاب شدند.کارآزمایی در فاز 2-3انجام شد.
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    En Patients referring to Kermanshah Dentistry School are classified in four group.In each group a set of complete dentures was made for each patient. The studied occlusions were: 1- bilateral balanced occlusion in which the most number of the teeth are in contact with all mandible movements, 2- lingualized occlusion in which just lingual cusps of maxillary teeth are the only ones in contact with the central fossa of mandibular teeth but the buccal cusps do not have any contact, 3- buccalized occlusion, the newfound occlusion in this study, in which just buccal cusps of mandibular teeth are in contact with the central fossa of maxillary teeth but the lingual cusps do not have any contact.4-canin guidance occlusion teeth are arranged that during side movements there is contact only on worker side of canine and premolar teeth and molar teeth of worker side and all teeth of balance side are out of contact. After denture delivery and examinations after a day and a week, the satisfaction level of the patient was assessed at the end of month using a questionnaire.In this double blind study patients and researchers were not aware of the details and method of randomization. Stratified randomization was used in this study as a method of randomization.
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    بیماران مراجعه کننده به دانشکده دندان پزشکی کرمانشاه در چهار گروه طبقه بندی می شوند. در هر گروه برای هر بیمار یک دست دندان مصنوعی با رابطه اکلوزالی یکسان در آن گروه ساخته می شود.اکلوژن های مورد مطالعه عبارتند از: 1- اکلوژن بالانس شده دوطرفه که در آن درتمام حرکات جانبی فک پایین حداکثر تعداد دندان ها درتماس باهم قرار می گیرند، 2- اکلوژن لینگوالی شده که در آن تنها کاسپ های پالاتال دندان های بالا با فوسای مرکزی دندان های پایین تماس دارند و کاسپ های باکال هیچ تماسی ندارند، 3- اکلوژن جدید این مطالعه، اکلوژن باکالی شده است که در آن تنها کاسپ های باکال دندان های پایین با فوسای مرکزی دندان های بالا تماس دارند. 4-اکلوژن کانین گاید که دندان ها طوری چیده می شوند که حین حرکات طرفی فقط در سمت کارگر دندان های کانین وپره مولرها تماس وجود داشته باشد و دندان های مولر سمت کارگر و تمام دندان های سمت بالانس خارج از تماس قرار بگیرند. پس از تحویل دست دندان ها به بیماران وانجام معاینات یک روز بعد ویک هفته بعد، در پایان ماه با تکمیل پرسشنامه میزان رضایت بیماران از دنچرها بررسی می شود.در این مطالعه دوسویه کور بیماران وپژوهشگران از جزئیات مطالعه و نحوه تصادفی سازی آگاهی ندارند. در این مطالعه از روش تصادفی سازی طبقه بندی شده استفاده شد.
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    edentulous patients; at least 3 month past from the last teeth extraction; no sever resorbed ridge; angle class 1 or mild class 2/3 jaw relation; signing the informed consent Exclusion criteria: uncontrolled systemic disease; mental problems; unwillingness to keep on the study
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    بی دندانی کامل، حداقل سه ماه از کشیدن آخرین دندان گذشته باشد،عدم مشاهده تحلیل های شدید ریج ،رابطه فکی کلاس 1 یا کلاس های 2و3 خفیف انگل،امضای رضایت نامه آگاهانه معیار های خروج: بیماری سیستمیک کنترل نشده؛ مشکلات روحی و روانی ؛ عدم رضایت برای ادامه مطالعه
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    1- bilateral balanced occlusion in which the most number of the teeth are in contact with all mandible movements. 2- lingualized occlusion in which just lingual cusps of maxillary teeth are the only ones in contact with the central fossa of mandibular teeth but the buccal cusps do not have any contact. 3- buccalized occlusion, the newfound occlusion in this study, in which just buccal cusps of mandibular teeth are in contact with the central fossa of maxillary teeth but the lingual cusps do not have any contact. 4-canin guidance occlusion teeth are arranged that during side movements there is contact only on worker side of canine and premolar teeth and molar teeth of worker side and all teeth of balance side are out of contact.
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    1- اکلوژن بالانس شده دوطرفه که در آن درتمام حرکات جانبی فک پایین حداکثر تعداد دندان ها درتماس باهم قرار می گیرند. 2- اکلوژن لینگوالی شده که در آن تنها کاسپ های پالاتال دندان های بالا با فوسای مرکزی دندان های پایین تماس دارند و کاسپ های باکال هیچ تماسی ندارند. 3- اکلوژن جدید این مطالعه، اکلوژن باکالی شده است که در آن تنها کاسپ های باکال دندان های پایین با فوسای مرکزی دندان های بالا تماس دارند. 4-اکلوژن کانین گاید که دندان ها طوری چیده می شوند که حین حرکات طرفی فقط در سمت کارگر دندان های کانین وپره مولرها تماس وجود داشته باشد و دندان های مولر سمت کارگر و تمام دندان های سمت بالانس خارج از تماس قرار بگیرند.
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    En Increasing patients' satisfaction and obtaining more complete information about this occlusion to increase the performance of artificial teeth.
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    افزایش رضایت مندی بیماران و دست یابی به اطلاعات کامل تر از این اکلوژن جهت افزایش عملکرددندان های مصنوعی.
  • General information

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    Year
    Yes
    No
    1
    1
    1
    90
    120
    2016-05-14, 1395/02/25
    2015-09-27, 1394/07/05
    2016-12-21, 1395/10/01
    2017-11-11, 1396/08/20
    Comparing satisfaction level of edentulous patients by three types of occlusal scheme in complete denture
    Comparing satisfaction level of edentulous patients by four types of occlusal scheme in complete denture
    مقایسه میزان رضایت مندی بیماران بی دندان در بین سه نوع مختلف روابط دندان های عقبی در دست دندان مصنوعی
    مقایسه میزان رضایت مندی بیماران بی دندان در بین چهار نوع مختلف روابط دندان های عقبی در دست دندان مصنوعی
    Comparing satisfaction level of edentulous patients with bilateral balanced, lingualized and buccalized denture articulations
    Comparing satisfaction level of edentulous patients with bilateral balanced, lingualized and buccalized denture articulations and canine guidance nonbalanced denture articulations
    مقایسه میزان رضایت مندی بیماران بی دندان از سه نوع دنچر کامل دارای اکلوژن بالانس شده دوطرفه، لینگوالی شده و باکالی شده
    مقایسه میزان رضایت مندی بیماران بی دندان از سه نوع دنچر کامل دارای اکلوژن بالانس شده دوطرفه، لینگوالی شده و باکالی شده و یک نوع دنچر کامل دارای اکلوژن نان بالانس شده کانین گاید
    Edentulous patients
    At least 3 month past from the last teeth extraction
    No sever resorbed ridge;
    Angle class 1 or mild class 2/3 jaw relation
    Signing the informed consent
    بی دندانی کامل
    حداقل سه ماه از کشیدن آخرین دندان گذشته باشد
    عدم مشاهده تحلیل های شدید ریج
    رابطه فکی کلاس 1 یا کلاس های 2و3 خفیف انگل
    امضای رضایت نامه آگاهانه
    Uncontrolled systemic disease
    Mental problems
    Unwillingness to keep on the study
    بیماری سیستمیک کنترل نشده
    مشکلات روحی و روانی
    عدم رضایت برای ادامه مطالعه
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    En The sampling method is simplified randomly. A line is generated and 120 people are randomly selected by numbers. According to Cochran's formula, a probability error of 5% was calculated for a sample size of 120.
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    روش نمونه گیری به صورت تصادفی ساده می باشد.لیستی تهیه شده و 120 نفر توسط اعداد تصادفی انتخاب می شوند. طبق فرمول کوکران با محاسبه خطای احتمالی 5 درصد حجم نمونه برابر 120 نفر محاسبه گردید.
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    En In this double blind study patients and researchers were not aware of the details and method of randomization. Stratified randomization was used in this study as a method of randomization.
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    در این مطالعه دوسویه کور بیماران وپژوهشگران از جزئیات مطالعه و نحوه تصادفی سازی آگاهی ندارند. در این مطالعه از روش تصادفی سازی طبقه بندی شده استفاده شد.
  • Ethics committees

    #1
    2015-10-20, 1394/07/28
    2017-09-06, 1396/06/15
    kums.rec.1394.324
    IR.KUMS.REC.1396.300
  • Intervention groups

    #1
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    Treatment - Other
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    Making a set of complete denture with canine guidance occlusion that can be contacted during sidewalks only on the side of the worker of the canines and the molars, and the molar teeth of the worker side and all the teeth on the balancing side are out of.
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    ساخت یکسری دندان با نوع اکلوژن کانین گاید،که در این اکلوژن دندان ها طوری چیده می شوند که حین حرکات طرفی فقط در سمت کارگر دندان های کانین وپره مولرها تماس وجود داشته باشد و دندان های مولر سمت کارگر و تمام دندان های سمت بالانس خارج از تماس قرار بگیرند.
  • Recruitment centers

    #1
    Name of recruitment center - English: The school of Dentistry, Kermanshah University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی کرمانشاه، دانشکده دندانپزشکی
    Full name of responsible person - English: Mohaddese Arabzade
    Full name of responsible person - Persian: محدثه عرب زاده
    Street address - English: The school of Dentistry, Kermanshah University of Medical Sciences, kermanshah, Iran
    Street address - Persian: ایران، کرمانشاه، دانشگاه علوم پزشکی کرمانشاه، دانشکده دندانپزشکی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: The school of Dentistry, Kermanshah University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی کرمانشاه، دانشکده دندانپزشکی
    Full name of responsible person - English: Mohaddese Arabzade
    Full name of responsible person - Persian: محدثه عرب زاده
    Street address - English: The school of Dentistry, Kermanshah University of Medical Sciences, kermanshah, Iran
    Street address - Persian: ایران، کرمانشاه، دانشگاه علوم پزشکی کرمانشاه، دانشکده دندانپزشکی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6713954658
    Phone: +98 83 4512 6083
    Fax:
    Email: fatemeh.salari.dent1@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Behrooz Hamzeh
    Full name of responsible person - Persian: بهروز حمزه
    Street address - English: Vice Chancellor for Research Kermanshah University of Medical Sciences, Central building, Shahid Beheshti Boulevard, Kermanshah
    Street address - Persian: کرمانشاه، بلوار شهید بهشتی، ساختمان مرکزی، معاونت پژوهشی دانشگاه علوم پزشکی کرمانشاه
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Farid Najafi
    Full name of responsible person - Persian: فرید نجفی
    Street address - English: Vice Chancellor for Research Kermanshah University of Medical Sciences, Central building, Shahid Beheshti Boulevard, Kermanshah
    Street address - Persian: کرمانشاه، بلوار شهید بهشتی، ساختمان مرکزی، معاونت پژوهشی دانشگاه علوم پزشکی کرمانشاه
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6715847141
    Phone: +98 83 3729 6591
    Fax:
    Email: fnajafi@kums.ac.ir
    Web page address:
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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: Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Mohaddese Arabzadeh
    Full name of responsible person - Persian: محدثه عرب زاده
    Position - English: Under graduated Student of Dentistry
    Position - Persian: دانشجوی دکترای عمومی دندانپزشکی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: The school of Dentistry, shariati Street, Kermanshah
    Street address - Persian: کرمانشاه، خیابان شریعتی، دانشکده دندان پزشکی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 837277030
    Mobile:
    Fax:
    Email: arabzade.m50@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Mohaddese Arabzadeh
    Full name of responsible person - Persian: محدثه عرب زاده
    Position - English: Under graduated Student of Dentistry
    Position - Persian: دانشجوی دکترای عمومی دندانپزشکی
    Latest degree: med_doctor
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: The school of Dentistry, shariati Street, Kermanshah
    Street address - Persian: کرمانشاه، خیابان شریعتی، دانشکده دندان پزشکی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6713954658
    Phone: +98 837277030
    Mobile: +98 935 536 6456
    Fax:
    Email: arabzade.m50@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Hedayat Moradpour
    Full name of responsible person - Persian: هدایت مرادپور
    Position - English: Prosthodontics Specialist
    Position - Persian: دکترای تخصصی پروتز های دندانی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Prosthodontics, The school of Dentistry, Kermanshah University of Medical Sciences , Iran
    Street address - Persian: ایران، دانشگاه علوم پزشکی کرمانشاه، دانشکده دندانپزشکی،گروه پروتز های دندانی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 83 3729 6910
    Mobile: +98 918 859 7870
    Fax:
    Email: h.moradpour@kums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Hedayat Moradpour
    Full name of responsible person - Persian: هدایت مرادپور
    Position - English: Prosthodontics Specialist
    Position - Persian: دکترای تخصصی پروتز های دندانی
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Prosthodontics, The school of Dentistry, Kermanshah University of Medical Sciences , Iran
    Street address - Persian: ایران، دانشگاه علوم پزشکی کرمانشاه، دانشکده دندانپزشکی،گروه پروتز های دندانی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6713954658
    Phone: +98 83 3729 6910
    Mobile: +98 918 859 7870
    Fax:
    Email: h.moradpour@kums.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Mohaddese Arabzadeh
    Full name of responsible person - Persian: محدثه عرب زاده
    Position - English: Under graduated Student of Dentistry
    Position - Persian: دانشجوی دکترای عمومی دندانپزشکی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Mobile: +98 939 474 9449
    Fax:
    Email: arabzade.m50@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Mohaddese Arabzadeh
    Full name of responsible person - Persian: محدثه عرب زاده
    Position - English: Under graduated Student of Dentistry
    Position - Persian: دانشجوی دکترای عمومی دندانپزشکی
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: ایران، کرمانشاه، دانشگاه علوم پزشکی کرمانشاه، دانشکده دندانپزشکی
    Street address - Persian: The school of Dentistry, Kermanshah University of Medical Sciences, kermanshah, Iran
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6713954658
    Phone: +98 83 4512 6083
    Mobile: +98 939 474 9449
    Fax:
    Email: arabzade.m50@gmail.com
    Web page address:
  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided

Protocol summary

Study aim
The aim of this study was to compare patient satisfaction with four types of denture occlusion.
Design
En In this study, 120 patients edentulous and criteria of the study referred to dental school Kermanshah are selected . The participants were randomly selected. The test was carried out in Phase2-3.
Settings and conduct
En Patients referring to Kermanshah Dentistry School are classified in four group.In each group a set of complete dentures was made for each patient. The studied occlusions were: 1- bilateral balanced occlusion in which the most number of the teeth are in contact with all mandible movements, 2- lingualized occlusion in which just lingual cusps of maxillary teeth are the only ones in contact with the central fossa of mandibular teeth but the buccal cusps do not have any contact, 3- buccalized occlusion, the newfound occlusion in this study, in which just buccal cusps of mandibular teeth are in contact with the central fossa of maxillary teeth but the lingual cusps do not have any contact.4-canin guidance occlusion teeth are arranged that during side movements there is contact only on worker side of canine and premolar teeth and molar teeth of worker side and all teeth of balance side are out of contact. After denture delivery and examinations after a day and a week, the satisfaction level of the patient was assessed at the end of month using a questionnaire.In this double blind study patients and researchers were not aware of the details and method of randomization. Stratified randomization was used in this study as a method of randomization.
Participants/Inclusion and exclusion criteria
edentulous patients; at least 3 month past from the last teeth extraction; no sever resorbed ridge; angle class 1 or mild class 2/3 jaw relation; signing the informed consent Exclusion criteria: uncontrolled systemic disease; mental problems; unwillingness to keep on the study
Intervention groups
1- bilateral balanced occlusion in which the most number of the teeth are in contact with all mandible movements. 2- lingualized occlusion in which just lingual cusps of maxillary teeth are the only ones in contact with the central fossa of mandibular teeth but the buccal cusps do not have any contact. 3- buccalized occlusion, the newfound occlusion in this study, in which just buccal cusps of mandibular teeth are in contact with the central fossa of maxillary teeth but the lingual cusps do not have any contact. 4-canin guidance occlusion teeth are arranged that during side movements there is contact only on worker side of canine and premolar teeth and molar teeth of worker side and all teeth of balance side are out of contact.
Main outcome variables
En Increasing patients' satisfaction and obtaining more complete information about this occlusion to increase the performance of artificial teeth.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2016021326538N1
Registration date: 2016-05-12, 1395/02/23
Registration timing: registered_while_recruiting

Last update: 2018-01-05, 1396/10/15
Update count: 1
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Hedaiat Moradpoor
Name of organization / entity
Kermanshah University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 83 3729 6910
Email address
h.moradpour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-09-27, 1394/07/05
Expected recruitment end date
2017-11-11, 1396/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing satisfaction level of edentulous patients with bilateral balanced, lingualized and buccalized denture articulations and canine guidance nonbalanced denture articulations
Public title
Comparing satisfaction level of edentulous patients by four types of occlusal scheme in complete denture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Edentulous patients At least 3 month past from the last teeth extraction No sever resorbed ridge; Angle class 1 or mild class 2/3 jaw relation Signing the informed consent
Exclusion criteria:
Uncontrolled systemic disease Mental problems Unwillingness to keep on the study
Age
From 50 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
En The sampling method is simplified randomly. A line is generated and 120 people are randomly selected by numbers. According to Cochran's formula, a probability error of 5% was calculated for a sample size of 120.
Blinding (investigator's opinion)
Double blinded
Blinding description
En In this double blind study patients and researchers were not aware of the details and method of randomization. Stratified randomization was used in this study as a method of randomization.
Placebo
Not used
Assignment
Parallel
Other design features
In this double blind study patients and researchers were not aware of the details and method of randomization. Stratified randomization was used in this study as a method of randomization.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-09-06, 1396/06/15
Ethics committee reference number
IR.KUMS.REC.1396.300

Health conditions studied

1

Description of health condition studied
Edentulous
ICD-10 code
k06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified

Primary outcomes

1

Description
Patients' Satisfaction
Timepoint
After 1 Month
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Making a set of complete denture with new Buccalized occlusion in that in this type of occlusion just buccal cusps of mandibular teeth are in contact with the central fossa of maxillary teeth whereas the lingual cusps do not have any contacts.
Category
Treatment - Other

2

Description
Making a set of complete denture with Lingualized occlusion in that in this type of occlusion lingual cusps of maxillary teeth are the only ones in contact with the central fossa of mandibular teeth but the buccal cusps do not have any contacts.
Category
Treatment - Other

3

Description
Making a set of complete denture with Balanced bilateral occlusion in that in this type of occlusion the most number of the tooth must be in contact at the all of mandible movement.
Category
Treatment - Other

4

Description
Making a set of complete denture with canine guidance occlusion that can be contacted during sidewalks only on the side of the worker of the canines and the molars, and the molar teeth of the worker side and all the teeth on the balancing side are out of.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The school of Dentistry, Kermanshah University of Medical Sciences
Full name of responsible person
Mohaddese Arabzade
Street address
The school of Dentistry, Kermanshah University of Medical Sciences, kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 4512 6083
Email
fatemeh.salari.dent1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice Chancellor for Research Kermanshah University of Medical Sciences, Central building, Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3729 6591
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohaddese Arabzadeh
Position
Under graduated Student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Street address
The school of Dentistry, shariati Street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 837277030
Fax
Email
arabzade.m50@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hedayat Moradpour
Position
Prosthodontics Specialist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Prosthodontics, The school of Dentistry, Kermanshah University of Medical Sciences , Iran
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6910
Fax
Email
h.moradpour@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohaddese Arabzadeh
Position
Under graduated Student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
ایران، کرمانشاه، دانشگاه علوم پزشکی کرمانشاه، دانشکده دندانپزشکی
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 4512 6083
Fax
Email
arabzade.m50@gmail.com
Web page address

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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