Overview
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
Description
Patient/population:
Patients that range from 7-14 years of age with with at least one non-cavitated WSL located on smooth surfaces of maxillary or mandibular permanent teeth and comparable in size, opacity, and whitish appearance.
- Intervention
I1: Self-Assembling Peptide (P11-4) I2: Self-Assembling Peptide (P11-4) with fluoride varnish
Comparator Resin Infiltration
- Outcome
Primary outcome
- Esthetic Improvement of white spot lesion
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: change in Percentage
• Tooth remineralization
- Outcome measure: International Caries Detection and Assessment System (ICDAS) score.
Outcome measuring Device: Visual and Clinical examination by operator Outcome measuring Unit : Numerical score from 0-6
2. Outcome measure: Quantitative light Fluorescence score from WSL Outcome measuring Device: Diagnodent Pen Outcome measuring Unit: Numerical score from 0-99
Secondary outcome
Outcome measure: Patient Satisfaction Outcome measuring Device Likert 5-point faces scale ranging from very sad to very happy
Outcome measuring Unit :Numerical score from 1-5
Study design: Randomized clinical trial Time: 6 months
Eligibility
Inclusion Criteria:
- Age (a range from 7-14 years of age was determined)
- Good general health (absence of disease/no handicaps, to ensure oral care at home)
- Preserved pulp vitality of the teeth.
- Consolidated oral care daily.
- Agreement by patient and parents (or guardians) to participate in the study
Exclusion Criteria:
- Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency).
- Teeth revealing any restorations were excluded from the current study.
- Any previous or planned WSL treatment.