Prevention of White Spot Lesions Using Bioactive Gel
Principal Investigator,Resident at Cairo University
1 other identifier
interventional
330
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJuly 17, 2023
July 1, 2023
4 months
June 24, 2023
July 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
Application of bioactive gel on teeth in patients assigned for orthodontic treatment
EXPERIMENTALApplication 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
ACTIVE COMPARATORApplication 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
Interventions
Application of bioactive gel to prevent white spot lesions in orthodontic patients
Application of fluoride gel to prevent white spot lesions in orthodontic patients
Eligibility Criteria
You may qualify if:
- Patients assigned for orthodontic treatment with fixed appliances
- Sound teeth with fixed orthodontic appliances
- Either maxillary or mandibular teeth or both
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- double
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prevention of white spot lesions in patients undergoing orthodontic treatment using bioactive gel versus fluoride gel
Study Record Dates
First Submitted
June 24, 2023
First Posted
July 17, 2023
Study Start
August 1, 2023
Primary Completion
December 1, 2023
Study Completion
January 1, 2025
Last Updated
July 17, 2023
Record last verified: 2023-07