NCT05948228

Prevention of White Spot Lesions Using Bioactive Gel

Principal Investigator,Resident at Cairo University

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 15 Years – 28 Years
• Healthy volunteers: Accepted

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.

Conditions

• White Spot Lesions

Interventions

Type	Name	Description
DRUG	giomer based bioactive gel	Application of bioactive gel to prevent white spot lesions in orthodontic patients
DRUG	Fluoride gel	Application of fluoride gel to prevent white spot lesions in orthodontic patients

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-12-01
• Completion: 2025-01-01
• First posted: 2023-07-17
• Last updated: 2023-07-17