Evaluation the Preventive Effect of Two Concentration of Xylitol Varnish vs Fluoride Varnish on Enamel Demineralization Around Orthodontic Brackets: A randomized controlled trial
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General information
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Reviewer requests of an orthodontics journal to continue the study until the end of orthodontic treatment and to add secondary outcomes.
Reviewer requests of an orthodontics journal to continue the study until the end of orthodontic treatment and to add secondary outcomes.
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درخواست داوران یک ژورنال ارتودنسی برای ادامه مطالعه تا پایان درمان ارتودنسی و اضافه کردن پیامد های ثانویه.
درخواست داوران یک ژورنال ارتودنسی برای ادامه مطالعه تا پایان درمان ارتودنسی و اضافه کردن پیامد های ثانویه.
Primary outcomes
#1
Before starting intervention, 3 and 6 month later.
Before starting intervention, 3 and 6 months later and at the end of orthodontic treatment.
Before starting intervention, 3 and 6 monthmonths later and at the end of orthodontic treatment.
قبل از شروع مداخله، 3 و 6 ماه بعد
قبل از شروع مداخله، 3 و 6 ماه بعد و در انتهای درمان ارتودنسی.
قبل از شروع مداخله، 3 و 6 ماه بعد و در انتهای درمان ارتودنسی.
Secondary outcomes
#1
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Visual assessment of white spot lesions.
Visual assessment of white spot lesions.
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ارزیابی بصری ضایعات سفید.
ارزیابی بصری ضایعات سفید.
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At the end of orthodontic treatment.
At the end of orthodontic treatment.
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در انتهای درمان ارتودنسی.
در انتهای درمان ارتودنسی.
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With the Gorelick index.
With the Gorelick index.
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از طریق شاخص گورلیک.
از طریق شاخص گورلیک.
#2
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Assessment of patients satisfaction of varnish therapy.
Assessment of patients satisfaction of varnish therapy.
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ارزیابی رضایت بیماران از درمان با وارنیش.
ارزیابی رضایت بیماران از درمان با وارنیش.
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After varnish therapy for patient
After varnish therapy for patient
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پس از درمان با وارنیش برای بیمار.
پس از درمان با وارنیش برای بیمار.
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Satisfaction questionnaire with binary (Yes/No) design.
Satisfaction questionnaire with binary (Yes/No) design.
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پرسشنامه رضایتمندی با طراحی دوتایی (بله/خیر).
پرسشنامه رضایتمندی با طراحی دوتایی (بله/خیر).
Protocol summary
Study aim
Comparing the anti-demineralization effect of different concentration of xylitol varnish with fluoride varnish and placebo varnish around the orthodontic brackets.
Design
Single center, double blind, four-arm parallel groups, placebo- and active randomized trials, with 1: 1: 1: 1: 1 ratio. Each group consists of 30 patients.Two groups will receive the experimental materials and two groups will serve as positive and negative controls (fluoride serves as positive control and placebo as negative control).
Settings and conduct
The subjects will be chosen within patients aged between 13 and 17 years requiring fixed orthodontic treatment at ٍEmam Reza dental clinic.
The patients, therapist and the data collector and analyzer will be blinded with respect to the type of varnish used. In this regard the varnish tubes will be labeled as A, B, C and D.
Participants/Inclusion and exclusion criteria
The inclusion criteria will be: Patients with Class I malocclusion and complete permanent dentition up to the first molars, good overall health and good oral hygiene, normal salivary flow rate and buffer capacity. Patients will be also excluded if they have history of previous orthodontic treatment or extractions, bleaching or topical fluoridation, severe crowding >6 mm, severely rotated teeth, Visible sign of caries, fluorosis, hypocalcification or developmental defects, dental filling which extended to the buccal surface, systemic or endocrine condition , craniofacial anomalies and clefts, and if they are smokers.
Intervention groups
1.10 % Xylitol varnish
2. 20% xylitol varnish
َ3. Ariadent sodium fluoride varnish 5% manufactured by Asia Chemi Teb Co
4. Placebo varnish
Xylitol and placebo varnishes will be specially manufactured by Asia Chemi Teb Co with the same basic composition as the commercial Ariadent fluoride varnish.
Main outcome variables
Diagnodent number
General information
Reason for update
Reviewer requests of an orthodontics journal to continue the study until the end of orthodontic treatment and to add secondary outcomes.
Acronym
IRCT registration information
IRCT registration number:IRCT20180913041032N1
Registration date:2018-10-14, 1397/07/22
Registration timing:registered_while_recruiting
Last update:2020-12-30, 1399/10/10
Update count:1
Registration date
2018-10-14, 1397/07/22
Registrant information
Name
Mojgan Shavakhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3625 7449
Email address
shavakhi.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-13, 1397/06/22
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Preventive Effect of Two Concentration of Xylitol Varnish vs Fluoride Varnish on Enamel Demineralization Around Orthodontic Brackets: A randomized controlled trial
Public title
Effect of Xylitol Varnish in Caries Prevention Around Orthodontic Brackets
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Class I malocclusion and complete permanent dentition up to the first molars.
Good overall health and good oral hygiene (full mouth plaque score < 20 %); with no bleeding after 30 seconds or having a discontinuous band of plaque at the gingival margin.
Normal salivary flow rate (>1.0 mL/min) and buffer capacity (final pH between 6.0 and 7.0).
Exclusion criteria:
History of previous orthodontic treatment or extractions, bleaching or topical fluoridation.
Severe crowding >6 mm, severely rotated teeth.
Visible sign of caries, fluorosis, hypocalcification or developmental defects.
Dental crowns, amalgam or composite filling which extended to the buccal surface.
Systemic or endocrine condition (such as cardiac pacemakers or diabetes mellitus).
Craniofacial anomalies and clefts
Smokers.
Age
From 13 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Dynamic randomized block design for balancing age and sex with block size of 8 using online randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, therapist and the data collector and analyzer will be blinded with respect to the type of varnish used. In this regard the varnish tubes will be labeled as A, B, C and D.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
School of Dentistry, Ghasr o Dasht St
City
shiraz
Province
Fars
Postal code
7195615878
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.SUMS.REC.1397.413
Health conditions studied
1
Description of health condition studied
Demineralization around Orthodontic brackets.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean Diagnodent number
Timepoint
Before starting intervention, 3 and 6 months later and at the end of orthodontic treatment.
Method of measurement
Diagnodent pen 2190
Secondary outcomes
1
Description
Visual assessment of white spot lesions.
Timepoint
At the end of orthodontic treatment.
Method of measurement
With the Gorelick index.
2
Description
Assessment of patients satisfaction of varnish therapy.
Timepoint
After varnish therapy for patient
Method of measurement
Satisfaction questionnaire with binary (Yes/No) design.
Intervention groups
1
Description
Intervention group 1: Xylitol varnish 10%
Category
Treatment - Drugs
2
Description
Intervention group 2: Xylitol varnish 20 %
Category
Treatment - Drugs
3
Description
Intervention group 3: Sodium fluoride varnish 5%
Category
Treatment - Drugs
4
Description
Control group: Placebo varnish
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Emam Reza
Full name of responsible person
Mojgan Shavakhi
Street address
Namazi Sq
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3625 7449
Email
shavakhi.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shabnam Ajami
Street address
Vice President of Research, School of Dentistry, Ghasr o Dasht St
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
dr.ajami.sh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mojgan Shavakhi
Position
Resident of Orthodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Ghasr o Dasht St
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3625 7449
Email
shavakhi.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hooman Zarif Najafi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Ghasr o Dasht St
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
zarifhooman@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojgan Shavakhi
Position
Resident of Orthodontic
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Ghasr o Dasht St.
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
shavakhi.m@gmail.com
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