Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions

Early Phase 1

Recruiting

• Conditions: White Spot Lesion
• Interventions: Drug: P11-4, a self-assembling peptide; Drug: P11-4, a self-assembling peptide with flouride; Drug: resin infilteration

• Registration Number: NCT06708481
• Lead Sponsor: October 6 University

Brief Summary

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

Detailed 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

1. 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

Study Timeline

• Study First Submitted: 2024-08-28
• Study Start: 2024-08-30
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Assembling Peptide (P11-4)	P11-4, a self-assembling peptide	self-assembling peptide in a brush-on liquid applied after cleaning and chemical preparation.The P11-4 peptide, called Curodont Repair (Credentis; now manufactured by vVARDIS)
Self-Assembling Peptide (P11-4) with fluoride varnish	P11-4, a self-assembling peptide with flouride	CR Fluoride Plus (CRFP) (Credentis; now manufactured by vVARDIS) also includes 500 ppm sodium fluoride and is registered with the US Food and Drug Administration (NDC 72247-101) as an anticaries drug under the fluoride monograph (21CFR355).
Resin Infilteration	resin infilteration	ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	6 months	Likert 5-point faces scale ranging from very sad to very happy

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Cairo, Giza, Egypt