Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
330 participants
INTERVENTIONAL
2023-08-31
2025-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Curodont Repair on Color Change of White Spot Lesions
NCT02913885
The Role of Fluoride Varnish Application in Preventing White Spot Lesions During Clear Aligner Treatment: A Controlled Split-Mouth Study
NCT07319884
Treatment of Postorthodontic White Spot Lesions
NCT03217084
Evaluation of Self-assembling Peptides Versus Amorphous Calcium Phosphate in the Treatment of White Spot Lesions
NCT07146464
Reminerlization Potential of GSE Gel versusCPP-ACP in Carious White Spot Lesions in Post Orthodontic Patients
NCT03966378
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Application of bioactive gel on teeth in patients assigned for orthodontic treatment
Application of bioactive gel on labial/buccal surfaces of teeth is done according to manufacturer instructions using microbrush followed by light curing
giomer based bioactive gel
Application of bioactive gel to prevent white spot lesions in orthodontic patients
Application of Fluoride on teeth in patients assigned for orthodontic treatment
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
Fluoride gel
Application of fluoride gel to prevent white spot lesions in orthodontic patients
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sound teeth with fixed orthodontic appliances
* Either maxillary or mandibular teeth or both
Exclusion Criteria
* 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
15 Years
28 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Farah Khaled El Hindawy
Prevention of white spot lesions in patients undergoing orthodontic treatment using bioactive gel versus fluoride gel
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Giomer based bioactive gel
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.