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Prevention of White Spot Lesions Using Bioactive Gel

Principal Investigator,Resident at Cairo University

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05948228
Enrollment
330
Registered
2023-07-17
Start date
2023-08-31
Completion date
2025-01-31
Last updated
2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesions

Keywords

white spot lesions, orthodontic treatment, Prevention, bioactive gel

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.

Interventions

DRUGgiomer based bioactive gel

Application of bioactive gel to prevent white spot lesions in orthodontic patients

Application of fluoride gel to prevent white spot lesions in orthodontic patients

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double

Eligibility

Sex/Gender
ALL
Age
15 Years to 28 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of white spot lesions using DIAGNOdentBaseline,change from baseline at 3 months,6 months,9 months and 12 monthsthe ability of the gels to prevent white spot lesions will be assessed using DIAGNOdent

Secondary

MeasureTime frameDescription
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 monthsthe ability of the gels to prevent white spot lesions will be assessed using ICDAS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026