Actively Recruiting
Clinical Outcome of Resin Infiltration Versus Self-Assembling Peptide (P11-4) in Treating White Spot Lesions - a Randomized Clinical Trial
Led by October 6 University · Updated on 2024-11-27
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
October 6 University
Lead Sponsor
A
Al-Azhar University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of two treatment methods for white spot lesions (WSL) on permanent teeth in patients aged 7 to 14 years. The study compares a self-assembling peptide called P11-4, used alone or combined with fluoride varnish, against resin infiltration. These treatments are being studied to improve the appearance and remineralization of these early tooth lesions, which are non-cavitated and located on smooth surfaces of the teeth. Participants will be randomly assigned to one of three treatment groups: P11-4 peptide applied as a brush-on liquid, P11-4 combined with a fluoride varnish containing 500 ppm sodium fluoride, or resin infiltration that uses a resin infiltrant to mask lesions by changing their refractive index. The study will last six months, during which these treatments will be applied and their effects monitored. During the study, participants will undergo clinical examinations and photographic analysis to measure changes in lesion appearance and tooth remineralization. Tools like the International Caries Detection and Assessment System (ICDAS) and a Diagnodent Pen will be used to assess tooth health. Patient satisfaction with the treatments will also be measured using a 5-point faces scale. Safety and treatment progress will be monitored throughout the six-month period.
CONDITIONS
Brief Title
Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 7 and 14 years
- Good general health with no diseases or handicaps
- Preserved pulp vitality in teeth
- Consistent daily oral care
- Agreement by patient and parents or guardians to participate in the study
You will not qualify if you...
- Patients with periodontal diseases or radiological pathologies
- Teeth with any restorations
- Any previous or planned treatment for white spot lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either self-assembling peptide (P11-4), self-assembling peptide with fluoride varnish, or resin infiltration applied to their white spot lesions.
1 baseline visit and periodic follow-up visits for treatment assessment
Trial Site Locations
Total: 1 location
1
October 6 University
Cairo, Giza Governorate, Egypt
Actively Recruiting
Research Team
D
Dina El Kharadly, PHD
N
nada adel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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