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Clinical Evaluation of Biomimetic Self -Assembling Peptide (p11-4) in The Remineralization of Early Enamel Caries in Permanent Teeth

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What is being tested

self assembling peptide p11-4 with fluoride

+ 5% sodium fluoride varnish

Drug
Who is being recruted

From 10 to 14 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2024
See protocol details

Summary

Principal SponsorTanta University
Study ContactSara Elgebaly, master
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 6, 2024

Actual date on which the first participant was enrolled.

This study focuses on finding effective ways to repair early tooth decay in children, specifically targeting the outer layer of permanent teeth known as enamel. The research compares two treatments: one group of children will receive a new treatment using a special peptide called P11-4 combined with fluoride varnish, while another group will receive just the fluoride varnish. This study is important as it could lead to better ways to strengthen teeth and prevent cavities in children, which is crucial for maintaining healthy teeth into adulthood. Children participating in the study will undergo a thorough dental examination to record their dental health. Each child's teeth will be cleaned before the treatment is applied. The study group will receive the P11-4 peptide treatment, which involves applying the substance to the teeth and allowing it to dry, while the control group will receive a fluoride varnish applied with a brush. The effectiveness of these treatments will be assessed using two methods: a scoring system to observe visible changes and a laser device to measure mineral changes in the teeth over a period of 1, 3, and 6 months. Participants will be instructed not to eat or drink for 30 minutes after the treatment, and they will maintain oral hygiene using a soft toothbrush and fluoridated toothpaste.

Official TitleClinical Evaluation of Biomimetic Self -Assembling Peptide (p11-4) in The Remineralization of Early Enamel Caries in Permanent Teeth
NCT06358066
Principal SponsorTanta University
Study ContactSara Elgebaly, master
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Presence of active non-cavitated carious white spot lesions with DIAGNO/dent reading from 5 to 17 ,on labial surfaces of permanent anterior teeth and International Caries Detection And Assessment System II (ICDAS II) ranging between 1 and 3.

The children' age range between 10 to14 years old.

Children had completed fixed orthodontic treatment within the past week.

Good oral hygiene with a plaque index score 0 or 1.

Show More Criteria

3 exclusion criteria prevent from participating
Children with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia.

Children had fluoride application less than 3 months before the study.

Presence of restoration and cavitation on the surface to be treated.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Group I (study group): Teeth will be treated with self-assembling peptide (P11-4) fluoride plus varnish.

Group II

Active Comparator
Group II (control group): Teeth will be treated with fluoride varnish.

Study Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

faculty of Dentistry,Tanta university

Tanta, EgyptOpen faculty of Dentistry,Tanta university in Google Maps
Recruiting soonOne Study Center