Prevention of White Spot Lesions Using Bioactive Gel

Phase 1

Not yet recruiting

• Conditions: White Spot Lesions
• Interventions: Drug: giomer based bioactive gel; Drug: Fluoride gel

• Registration Number: NCT05948228
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-06-24
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17
• Study Start: 2023-08
• Primary Completion: 2023-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Patients assigned for orthodontic treatment with fixed appliances
• Sound teeth with fixed orthodontic appliances
• Either maxillary or mandibular teeth or both

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Application of bioactive gel on teeth in patients assigned for orthodontic treatment	giomer based bioactive gel	Application of bioactive gel on labial/buccal surfaces of teeth is done according to manufacturer instructions using microbrush followed by light curing
Application of Fluoride on teeth in patients assigned for orthodontic treatment	Fluoride gel	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

Primary Outcome Measures

Name	Time	Method
incidence of white spot lesions using DIAGNOdent	Baseline,change from baseline at 3 months,6 months,9 months and 12 months	the ability of the gels to prevent white spot lesions will be assessed using DIAGNOdent

Secondary Outcome Measures

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