Prevention of White Spot Lesions Using Bioactive Gel

White Spot Lesions Clinical Trial

Official title:

Principal Investigator,Resident at Cairo University

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05948228
• Other study ID #: Giomer based bioactive gel
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2023
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: January 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• White Spot Lesions

Intervention

Drug:
• giomer based bioactive gel
Application of bioactive gel to prevent white spot lesions in orthodontic patients
• Fluoride gel
Application of fluoride gel to prevent white spot lesions in orthodontic patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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