Prevention of White Spot Lesions Using Bioactive Gel

Study Overview
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Brief Summary
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white spot lesions are a common problem and are reported in up to 96% of orthodontic patients. In this study, the preventive effect of bioactive gel is evaluated in comparison to fluoride.

Detailed Description
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Dental caries is a chronic infectious disease present worldwide and is among one of the most common oral diseases. It is a multifactorial disease resulting from imbalance between demineralization and remineralization initiated by acid producing bacteria in the microenvironment. The incipient form of caries, white spot lesions (WSL), is characterized by primitive enamel surface and subsurface demineralization and could be identified clinically by their chalky white appearance . Orthodontic treatment is a major risk factor for the development of WSL. They are reported in up to 96% of orthodontic patients. Many materials are being used to prevent white spot lesions with fluoride being the most commonly used . New materials have been emerged such as giomer based bioactive gel with the ability to release six ions Fluoride inhibits demineralization and promotes deposition of fluoroapatite. Aluminum helps to decrease demineralization as well by forming Alumino fluoro complexes. Borate reduces biofilm formation beside its antibacterial effect. Silica promotes remineralization by inducing apatite nucleation on the tooth surface. Strontium converts hydroxyapatite into strontium apatite thus increasing acid resistance and has an inhibitory effect on bacterial growth. Other ions such as Na act as strong base and have acid buffer capacity.

Official Title
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Principal Investigator,Resident at Cairo University

Conditions
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White Spot Lesions

Intervention / Treatment
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* Drug: giomer based bioactive gel
* Drug: Fluoride gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients assigned for orthodontic treatment with fixed appliances Sound teeth with fixed orthodontic appliances Either maxillary or mandibular teeth or both Exclusion Criteria: Patients with poor oral hygiene Allergic reaction to the materials used. Lack of compliance. xerostomia Evidence of parafunctional habits. Active carious lesions Dental fluorosis Hypocalcified teeth Systemic diseases affecting teeth such as Amelogenesis imperfecta Severe periodontal affection

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Application of bioactive gel on teeth in patients assigned for orthodontic treatment<br>Application of bioactive gel on labial/buccal surfaces of teeth is done according to manufacturer instructions using microbrush followed by light curing | Drug: giomer based bioactive gel<br>* Application of bioactive gel to prevent white spot lesions in orthodontic patients<br>|
| Active Comparator: Application of Fluoride on teeth in patients assigned for orthodontic treatment<br>Application of fluoride gel will be done using a gel loaded tray held in the mouth for 4 minutes .After removal of tray ,patients must spit out the residual gel. The use of suction is a must to avoid the problem of over ingestion | Drug: Fluoride gel<br>* Application of fluoride gel to prevent white spot lesions in orthodontic patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of white spot lesions using DIAGNOdent | the ability of the gels to prevent white spot lesions will be assessed using DIAGNOdent | Baseline,change from baseline at 3 months,6 months,9 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of white spot lesions using ICDAS (international caries detection and assessment system) | the ability of the gels to prevent white spot lesions will be assessed using ICDAS | Baseline,change from baseline at 3 months,6 months,9 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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white spot lesions, orthodontic treatment, Prevention, bioactive gel