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

NCT ID: NCT07146464

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-27
• Study Completion Date: 2026-06-30

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.

Detailed Description

White spot lesions (WSLs) are early signs of tooth decay that appear as milky white spots on tooth enamel, especially common after wearing braces. These lesions can last for many years and negatively affect appearance, especially on front teeth. This study investigates two promising treatment options to reverse or reduce the appearance of WSLs.

Study Design This is a randomized, split-mouth, double-blinded clinical trial conducted at the Operative Dentistry Department, Faculty of Dentistry, Ain Shams University. The trial includes patients between the ages of 15 and 25 with visible white spot lesions on both sides of their front teeth (ICDAS scores 1-2).

Each patient will receive:

SAP P11-4 (Curodont Repair) on one side of the mouth.

CPP-ACP (MI Varnish) on the other side.

The split-mouth design helps reduce differences between participants and improves the reliability of the results.

Intervention Procedure

Participants will undergo:

Initial oral hygiene instructions and professional cleaning.

Standardized digital and cross-polarized photography of the teeth.

Treatment application according to manufacturer instructions:

SAP P11-4 is applied twice (at baseline and 3 months), after cleaning and etching the enamel surface.

CPP-ACP is also applied twice (at baseline and 3 or 6 months), with post-application care instructions (avoid brushing or eating for 4 hours).

Outcome Measures Primary outcome: Change in color of the white spot lesions over 9 months, measured using digital photography and color analysis software (eLAB-prime).

Secondary outcomes:

Change in lesion size.

Visual scoring using the ICDAS II system.

Patient satisfaction with the treatment results, collected through a questionnaire.

The study aims to determine which treatment is more effective at improving the appearance and reducing the visibility of WSLs, with the goal of guiding future esthetic dental care.

Conditions

Dental Caries Tooth Demineralization; Post-Orthodontic Esthetic Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 2 Title: CPP-ACP Treatment

. 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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

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

Role: CONTACT

amany-mohamed@dent.asu.edu.eg

01002229647

Facility Contacts

faculty of Dentistry, Ain Shams University

Role: primary

amany-mohamed@dent.asu.edu.eg

01002229647

Other Identifiers

opd 22 23 (d)

Identifier Type: -

Identifier Source: org_study_id