Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial

NCT06708481 EARLY_PHASE1 RECRUITING

Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions

Details

Lead sponsor	October 6 University
Phase	EARLY_PHASE1
Status	RECRUITING
Enrolment	150
Start date	2024-08-30
Completion	2025-02

Conditions

• White Spot Lesion

Interventions

• P11-4, a self-assembling peptide
• P11-4, a self-assembling peptide with flouride
• resin infilteration

Primary outcomes

• Esthetic Improvement of white spot lesion — 6 months
  Outcome Measure: Photographic analysis Outcome measuring device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software Outcome measuring unit: Percentage change
• Tooth remineralization — 6 months
  ICDAS score Outcome Measure: ICDAS score Outcome measuring device: Visual and Clinical examination by operator Outcome measuring unit: Numerical value from 0-6 Outcome Measure: Quantitative Light Fluorescence score from WSL Outcome measuring device: Diagnodent pen Outcome measuring unit: Numerical value ranging from 0 to 99

Countries

Egypt