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Clinical assessment of laser application (Photobiomodulation) for reversal of soft-tissue local anesthesia in children

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History
# Registration date Revision Id
2 2018-12-22, 1397/10/01 74335
1 2018-08-24, 1397/06/02 57245
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  • Protocol summary

    randomized, double-blind, split-mouth clinical trial
    split-mouth ( each patient receives two treatments in each mandibular quadrant ) double-blind randomized clinical trial
    کارآزمايي باليني تصادفي، دو سو کور، split-mouth
    کارآزمايي باليني تصادفي، دو سو کور، (هر بیمار دو درمان در هر کوادرانت مندیبل دریافت می کند)
    این مطالعه در کودکان 4 تا 8سال مراجعه کننده به بخش کودکان دندانپزشکی دانشگاه علوم پزشکی تهران انجام خواهد شد. پس از بررسی از نظر معیارهای ورود و خروج، هر بیمار به صورت تصادفی به دو گروه دریافت کننده ی لیزر و بدون دریافت لیزر در دو جلسه درمانی با فاصله 7 تا 10 روز ( split- mouth) تقسیم می شود. بی حسی بیماران با استفاده از palpation هر 15 دقیقه تا زمان رفع بی حسی ارزیابی و ثبت خواهد شد. همچنین بیمار از نظر ترومای بافت نرم مورد ارزیابی قرار خواهد گرفت. مراقب بالینی،ارزیابی کننده پیامد، محقق، بیمار و آنالیز کننده در این مطالعه کور هستند.
    این مطالعه در کودکان 4 تا 8سال مراجعه کننده به بخش کودکان دندانپزشکی دانشگاه علوم پزشکی تهران انجام خواهد شد. پس از بررسی از نظر معیارهای ورود و خروج، هر بیمار به صورت تصادفی به دو گروه دریافت کننده ی لیزر و بدون دریافت لیزر در دو جلسه درمانی با فاصله 7 تا 10 روز تقسیم می شود. بی حسی بیماران با استفاده از پالپیشن هر 15 دقیقه تا زمان رفع بی حسی ارزیابی و ثبت خواهد شد. همچنین بیمار از نظر ترومای بافت نرم مورد ارزیابی قرار خواهد گرفت. مراقب بالینی،ارزیابی کننده پیامد، محقق، بیمار و آنالیز کننده در این مطالعه کور هستند.
    4 - 8- year-old children who are able to understand and respond to soft tissue sensation
    Inclusion criteria: 4 - 8- year-old children who are able to understand and respond to soft tissue sensation Requiring treatment by injection under anesthetic infiltration of mandibular primary first molar Exclusion criteria: children with systemic conditions that prevent dental treatment under local anesthesia
    کودکان با سن 4 الی8 سال که قادر به درک و پاسخگویی در مورد حس بافت نرم باشد
    معیار ورود : کودکان با سن 4 الی8 سال که قادر به درک و پاسخگویی در مورد حس بافت نرم باشد نیازمند درمان تحت بی حسی با تزریق انفیلتره مولر اول شیری مندیبل می باشند معیار عدم ورود: کودکان با شرایط سیستمیک که مانع انجام درمان دندانپزشکی تحت بی حسی موضعی می شود
    In each person one side will be randomly selected as intervention group and the other side will be acted as the control group (split- mouth). At the end of treatment, the intervention group will be exposed to diode laser radiation and in the control group, the laser when it's off is symbolically illuminated with the same distance and the same duration.
    The intervention group will be exposed to diode laser radiation and in the control group, the laser when it's off is symbolically illuminated with the same distance and the same duration.
    در هر فرد یک سمت به صورت تصادفی به عنوان گروه مداخله انتخاب شده و طرف دیگر به عنوان گروه کنترل عمل می کند (split- mouth). در انتهای کار درمانی گروه مداخله، تحت تابش لیزر دیود قرار خواهند گرفت و در گروه کنترل، لیزر خاموش به صورت نمادین با فاصله ی یکسان و مدت زمان یکسان تظاهر به تابش می شود.
    گروه مداخله، تحت تابش لیزر دیود قرار خواهند گرفت و در گروه کنترل، لیزر خاموش به صورت نمادین با فاصله ی یکسان و مدت زمان یکسان تظاهر به تابش می شود.
    the reversal time for normal sensation of soft tissue and the incidence of soft-tissue trauma in the two intervention and control groups will be evaluated and compared
    The reversal time for normal sensation of soft tissue and the incidence of soft-tissue trauma in the two intervention and control groups will be evaluated and compared

  • General information

    The lack of a history of allergy to the substance of numbness and sulfite
    Not receiving any pain medication at least 24 hours before treatment
    The absence of any systemic conditions that prevent dental treatment under local anesthesia
    History of allergy to the substance of numbness and sulfite
    Receiving any pain medication at least 24 hours before treatment
    Any systemic conditions that prevent dental treatment under local anesthesia
    عدم وجود تاریخچه ی آلرژی به ماده بی حسی و سولفیت
    عدم دریافت هر گونه داروی مسکن حداقل 24 ساعت قبل از درمان
    عدم وجود هر گونه شرایط سیستمیک که مانع انجام درمان دندانپزشکی تحت بی حسی موضعی می شود
    تاریخچه ی آلرژی به ماده بی حسی و سولفیت
    دریافت هر گونه داروی مسکن حداقل 24 ساعت قبل از درمان
    هر گونه شرایط سیستمیک که مانع انجام درمان دندانپزشکی تحت بی حسی موضعی می شود

  • Health conditions studied

    #1
    Local anaesthetics
    Local anaesthetics (Adverse effect in therapeutic use)
    The effect of laser in reversing local anesthesia to reduce complications
    The effect of laser in reversing local anesthesia
    تاثیر لیزر در بازگشت بی حسی موضعی جهت کاهش عوارض
    تاثیر لیزر در بازگشت بی حسی موضعی

  • Primary outcomes

    #1
    The effect of laser in reducing the duration of soft tissue anesthesia
    Time of soft tissue local anesthesia
    تاتیر لیزر در کاهش مدت زمان بی حسی بافت نرم
    زمان بی حسی بافت نرم
    15 minutes
    Assessment of sensation of soft tissue every 15 minutes
    15 دقیقه
    ارزیابی حس بافت نرم هر 15 دقیقه
    Palpation in trained child
    Palpation with explorer in trained child
    Palpation در کودک آموزش دیده
    لمس با سوند در کودک آموزش دیده
    #2
    Trauma to soft tissue
    empty
    تروما به بافت نرم
    empty
    At the end of the treatment and 24 hours later
    empty
    در انتهای کار درمانی و 24 ساعت بعد
    empty
    observation
    empty
    مشاهده
    empty

  • Secondary outcomes

    #1
    Assessment of vital signs
    Trauma to soft tissue
    ارزیابی علائم حیاتی
    تروما به بافت نرم
    In succession
    At the end of the treatment and 24 hours later
    به صورت متوالی
    در انتهای کار درمانی و 24 ساعت بعد
    Pulse oximetry
    Observation
    پالس اکسی متر
    مشاهده

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Hosseini
    Full name of responsible person - Persian: زهرا حسینی
    Position - English: Resident of Pediatric Dentistry
    Position - Persian: رزیدنت دندانپزشکی کودکان
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: N Kargar Ave.,Tehran
    Street address - Persian: خیابان کارگر شمالی، تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439955991
    Phone: +98 21 8801 5950
    Mobile: +98 912 812 9604
    Fax:
    Email: z-hosseini@razi.tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Hosseini
    Full name of responsible person - Persian: زهرا حسینی
    Position - English: Resident of Pediatric Dentistry
    Position - Persian: رزیدنت دندانپزشکی کودکان
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: North Kargar Ave.,Tehran
    Street address - Persian: خیابان کارگر شمالی، تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439955991
    Phone: +98 21 8801 5950
    Mobile: +98 912 812 9604
    Fax:
    Email: z-hosseini@razi.tums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Hosseini
    Full name of responsible person - Persian: زهرا حسینی
    Position - English: Resident of Pediatric Dentistry
    Position - Persian: رزیدنت دندانپزشکی کودکان
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: N Kargar Ave.,Tehran
    Street address - Persian: خیابان کارگر شمالی، تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439955991
    Phone: +98 21 8801 5950
    Mobile: +98 912 812 9604
    Fax:
    Email: z-hosseini@razi.tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Hosseini
    Full name of responsible person - Persian: زهرا حسینی
    Position - English: Resident of Pediatric Dentistry
    Position - Persian: رزیدنت دندانپزشکی کودکان
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: North Kargar Ave.,Tehran
    Street address - Persian: خیابان کارگر شمالی، تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439955991
    Phone: +98 21 8801 5950
    Mobile: +98 912 812 9604
    Fax:
    Email: z-hosseini@razi.tums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Hosseini
    Full name of responsible person - Persian: زهرا حسینی
    Position - English: Resident of Pediatric Dentistry
    Position - Persian: رزیدنت دندانپزشکی کودکان
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: N Kargar Ave.,Tehran
    Street address - Persian: خیابان کارگر شمالی، تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439955991
    Phone: +98 21 8801 5950
    Mobile: +98 912 812 9604
    Fax:
    Email: z-hosseini@razi.tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Hosseini
    Full name of responsible person - Persian: زهرا حسینی
    Position - English: Resident of Pediatric Dentistry
    Position - Persian: رزیدنت دندانپزشکی کودکان
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: North Kargar Ave.,Tehran
    Street address - Persian: خیابان کارگر شمالی، تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439955991
    Phone: +98 21 8801 5950
    Mobile: +98 912 812 9604
    Fax:
    Email: z-hosseini@razi.tums.ac.ir
    Web page address:

Protocol summary

Study aim
Determination of laser application in the removal of soft tissue local anesthesia in children
Design
split-mouth ( each patient receives two treatments in each mandibular quadrant ) double-blind randomized clinical trial
Settings and conduct
This study will be carried out in children ages 4 to 8 years old referred to the pediatric dentistry department of Tehran University of Medical Sciences. After the inclusion and exclusion criteria, patients will be randomly divided into two groups of treated with laser and without laser in two treatment sessions with an interval of 7 to 10 days (split- mouth). Patients' sensation of soft tissue will be evaluated and recorded every 15 minutes by palpation.The patient will also be evaluated for soft tissue trauma. clinical care, the outcome evaluator, researcher, patient and analyzer are blind at this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 4 - 8- year-old children who are able to understand and respond to soft tissue sensation Requiring treatment by injection under anesthetic infiltration of mandibular primary first molar Exclusion criteria: children with systemic conditions that prevent dental treatment under local anesthesia
Intervention groups
The intervention group will be exposed to diode laser radiation and in the control group, the laser when it's off is symbolically illuminated with the same distance and the same duration.
Main outcome variables
The reversal time for normal sensation of soft tissue and the incidence of soft-tissue trauma in the two intervention and control groups will be evaluated and compared

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180804040693N1
Registration date: 2018-08-24, 1397/06/02
Registration timing: prospective

Last update: 2019-01-08, 1397/10/18
Update count: 1
Registration date
2018-08-24, 1397/06/02
Registrant information
Name
Zahra Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4025
Email address
z-hosseini@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical assessment of laser application (Photobiomodulation) for reversal of soft-tissue local anesthesia in children
Public title
The effect of laser on soft tissue anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A child aged 4 to 8 years who is able to understand and respond to soft tissue sensation Complete the informed consent form by the parent or legal guardian of the patient Children who are ranked 3 or 4 on Frankl Rating Requiring treatment by injection under anesthetic infiltration of mandibular primary first molar
Exclusion criteria:
History of allergy to the substance of numbness and sulfite Receiving any pain medication at least 24 hours before treatment Any systemic conditions that prevent dental treatment under local anesthesia
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
After reviewing the inclusion and exclusion criteria, each patient randomly using simple randomization and individual (open envelope sealed) divided into two groups of treated with laser and without laser in two treatment sessions with an interval of 7 to 10 days (split- mouth). There are 9 envelopes from each of the four modes (right with laser radiation, right without laser radiation, left with laser radiation, left without laser radiation). We ask a patient to choose an envelope from 36 envelopes and the envelope will be opened by the person responsible for the laser radiation at the same time.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blind clinical care and the outcome evaluator and researcher, a separate person is responsible for laser radiation. So these people are blind at all stages of the laser radiation protocol. For blind the patient, at a meeting without laser treatment, the extinguishing laser appears symbolically with the same distance and the same duration of exposure. For blind analyzer, first analysis is done and then grouped into groups.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences
Street address
N Kargar, Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1397.057

Health conditions studied

1

Description of health condition studied
The effect of laser in reversing local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics (Adverse effect in therapeutic use)

Primary outcomes

1

Description
Time of soft tissue local anesthesia
Timepoint
Assessment of sensation of soft tissue every 15 minutes
Method of measurement
Palpation with explorer in trained child

Secondary outcomes

1

Description
Trauma to soft tissue
Timepoint
At the end of the treatment and 24 hours later
Method of measurement
Observation

Intervention groups

1

Description
Intervention group: Laser therapy with an 810 nm wavelength laser diode (Fox, ARC laser Germany) with a 0.5 cm2 cross-section handpiece with a density of 6 J / cm2, a power of 200 mw, and an irradiation time of 15 seconds per continuous wave in soft tissue at the injection side (Infiltration point and anesthetized points on the lower lip)
Category
Treatment - Other

2

Description
Control group: The Laser when it's off is symbolically illuminated with the same distance and the same duration
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences Faculty of Dentistry
Full name of responsible person
Zahra Hosseini
Street address
N Kargar, Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
dentistry@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Laser Research Center of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr. Bahman Seraj
Street address
Ghods St., Faculty of Dentistry, Dental Research Center
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8899 4824
Email
z-hosseini@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Laser Research Center of Dentistry, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Hosseini
Position
Resident of Pediatric Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
North Kargar Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
z-hosseini@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Hosseini
Position
Resident of Pediatric Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
North Kargar Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
z-hosseini@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Hosseini
Position
Resident of Pediatric Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
North Kargar Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
z-hosseini@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
information about the main outcome
When the data will become available and for how long
Starting the access period from 1399
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
further research
From where data/document is obtainable
Email to z-hosseini@razi.tums.ac.ir
What processes are involved for a request to access data/document
Explain the use of documentation that will be
Comments
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