Protocol summary
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Study aim
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Comparing the anti-demineralization effect of different concentration of xylitol varnish with fluoride varnish and placebo varnish around the orthodontic brackets.
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Design
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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).
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Diagnodent number
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2018-10-14, 1397/07/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-13, 1397/06/22
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Expected recruitment end date
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2018-12-11, 1397/09/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of Xylitol Varnish in Caries Prevention Around Orthodontic Brackets
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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.
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Age
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From 13 years old to 17 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Dynamic randomized block design for balancing age and sex with block size of 8 using online randomization.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-09-12, 1397/06/21
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Ethics committee reference number
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IR.SUMS.REC.1397.413
Health conditions studied
1
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Description of health condition studied
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Demineralization around Orthodontic brackets.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Mean Diagnodent number
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Timepoint
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Before starting intervention, 3 and 6 months later and at the end of orthodontic treatment.
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Method of measurement
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Diagnodent pen 2190
Secondary outcomes
1
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Description
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Visual assessment of white spot lesions.
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Timepoint
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At the end of orthodontic treatment.
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Method of measurement
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With the Gorelick index.
2
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Description
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Assessment of patients satisfaction of varnish therapy.
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Timepoint
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After varnish therapy for patient
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Method of measurement
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Satisfaction questionnaire with binary (Yes/No) design.
Intervention groups
1
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Description
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Intervention group 1: Xylitol varnish 10%
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Xylitol varnish 20 %
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Category
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Treatment - Drugs
3
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Description
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Intervention group 3: Sodium fluoride varnish 5%
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Category
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Treatment - Drugs
4
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Description
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Control group: Placebo varnish
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available