Actively Recruiting

Phase Not Applicable
Age: 15Years - 25Years
All Genders
NCT07146464

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

Led by Ain Shams University · Updated on 2025-09-10

18

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 15Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 15 and 25 years
  • At least one early carious lesion (ICDAS II code 1 or 2) on each side of the front teeth (right canine to left canine)
  • Lesion size and shape fully visible and accessible
  • Willing and able to attend all study visits and follow instructions
  • Good general health and oral hygiene
  • Not taking medications that affect saliva flow
  • Provided written informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

Actively Recruiting

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Research Team

A

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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