Evaluation of Self-assembling Peptides Versus Amorphous Calcium Phosphate in the Treatment of White Spot Lesions

NCT07146464 | Recruiting

• 1 other identifier: opd 22 23 (d)
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to compare the effectiveness of two remineralizing treatments for white spot lesions (WSLs) on the enamel surfaces of the front teeth. WSLs are early signs of tooth decay, often appearing after orthodontic treatment with braces. These white spots may persist for years and affect the esthetic appearance of teeth. The study will include male and female patients aged 15 to 25 who have at least one early carious lesion (ICDAS scores 1 or 2) on each side of their upper or lower front teeth. The purpose is to determine which treatment - Self-Assembling Peptides (SAP P11-4, Curodont Repair™) or Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP, MI Varnish™) - is more effective in improving the color and reducing the size of these lesions. Researchers will use a split-mouth design, where each patient receives both treatments - one on each side of the mouth. Standardized digital photographs will be taken before and after treatment to assess color changes and lesion size. Patients will also rate their satisfaction with the appearance of their teeth after treatment. The main questions the study will answer are: Does SAP P11-4 improve the color of white spot lesions more effectively than CPP-ACP? Is there a noticeable difference in lesion size reduction between the two treatments? How satisfied are patients with the outcomes of each treatment? Participants will be followed up at 3, 6, and 9 months after treatment. The results aim to guide clinicians toward the most effective treatment to improve the appearance of white spot lesions in young patients after orthodontic care.

Conditions

Dental Caries Tooth Demineralization; Post-Orthodontic Esthetic Defects

Keywords

White Spot Lesions - Enamel Demineralization - Self-Assembling Peptides - Casein Phosphopeptide-Amorphous Calcium Phosphate

Outcome Measures

Primary Outcomes (1)

• Change in white spot lesion color using standardized cross-polarized photography and digital color analysis

  The primary outcome is the change in the color of enamel white spot lesions, assessed through standardized digital photographs taken at baseline and at 3, 6, and 9 months. Images will be analyzed using eLAB-prime software for objective color quantification.

  Baseline, 3 months, 6 months, and 9 months

Secondary Outcomes (1)

• Change in lesion size of white spot lesions based on standardized clinical photographs

  Baseline, 3 months, 6 months, and 9 months

Study Arms (2)

Arm 2 Title: CPP-ACP Treatment

ACTIVE COMPARATOR

. Arm 2 (CPP-ACP Treatment) - Description: Participants receive Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) (MI Varnish™) applied to white spot lesions on the opposite side of the anterior teeth. The varnish is applied at baseline and again after 3 or 6 months, according to manufacturer guidelines.

Other: Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension

Arm 1 Title: SAP P11-4 Treatment

ACTIVE COMPARATOR

Participants receive Self-Assembling Peptides (SAP P11-4), a biomimetic agent that penetrates enamel white spot lesions and promotes remineralization by forming a 3D peptide scaffold within the lesion. The material is applied to white spot lesions on one side of the anterior teeth at baseline and again after 3 months, following manufacturer instructions.

Other: Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension

Interventions

Self-Assembling Peptide P11-4 Self-Assembling Peptide P11-4 is a biomimetic material applied topically to white spot lesions on the enamel. It diffuses into the lesion body and forms a three-dimension OTHER

Intervention: Self-Assembling Peptide P11-4 Intervention Description: Self-Assembling Peptide P11-4 (SAP P11-4) is a synthetic peptide designed to mimic natural enamel matrix proteins. It is applied to cleaned, etched enamel surfaces with white spot lesions. The peptide diffuses into the subsurface lesion and self-assembles into a 3D scaffold that promotes nucleation and growth of hydroxyapatite crystals. In this study, it is applied at baseline and re-applied after 3 months. The product used is Curodont™ Repair. Intervention: Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) Intervention Description: CPP-ACP is a milk-derived peptide complex that stabilizes calcium and phosphate ions in an amorphous form. When applied to enamel surfaces, it delivers these ions to promote remineralization of white spot lesions. In this study, MI Varnish™ is used as the source of CPP-ACP. The varnish is stirred and applied as a thin, uniform layer to cleaned tooth surfaces at baseline and

Arm 1 Title: SAP P11-4 Treatment; Arm 2 Title: CPP-ACP Treatment

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 15 and 25 years
• Presence of at least one tooth on each side of the anterior region (from right canine to left canine) affected by early carious lesions (ICDAS II code 1 or 2)
• Lesion size and form must be fully visible and accessible
• Willing and able to attend all study visits and follow instructions
• Good general health and oral hygiene
• Not taking any medication that affects salivary flow
• Provided written informed consent

You may not qualify if:

• Evidence of tooth erosion
• Prior fluoride varnish application before study treatment
• Hypoplastic enamel defects or multiple restorations on facial surfaces of anterior teeth
• High caries risk patients
• Known or suspected allergy to milk proteins
• Use of medications affecting salivary flow

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

RECRUITING

Central Study Contacts

Amany yasser mohamed, B.D.S., M.Sc.

CONTACT

01002229647; amany-mohamed@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study is described as double-blinded, meaning: Participants do not know which treatment is applied to which side. Outcome Assessors (those evaluating lesion color/size from photographs and ICDAS scores) are also blinded to group assignment. the Principal Investigator are not blinded, as they apply the interventions and know the treatment allocation during the procedure.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a split-mouth, double-blinded, randomized controlled trial using a crossover assignment model. Each participant receives both interventions - Self-Assembling Peptides (SAP P11-4) on one side of the anterior teeth and Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) on the opposite side. This design minimizes inter-subject variability and allows within-subject comparison of treatment outcomes.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: March 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-08

Locations

EG (1)