Clinical Evaluation of Biomimetic Self -Assembling Peptide (p11-4) in The Remineralization of Early Enamel Caries in Permanent Teeth
self assembling peptide p11-4 with fluoride
+ 5% sodium fluoride varnish
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
faculty of Dentistry,Tanta university
Tanta, EgyptOpen faculty of Dentistry,Tanta university in Google Maps