NCT06358066

The Remineralization of Early Enamel Caries in Permanent Teeth

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Accepted

Summary

Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth.

Detailed description

Study design This study will be conducted as a randomized controlled clinical trial. Study setting The study will be carried out in the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. Group assignment: Fifty children will be randomly allocated using simple random table into two groups as follows: * Group I (study group): Teeth will be treated with self-assembling peptide (P11-4) fluoride plus varnish. * Group II (control group): Teeth will be treated with fluoride varnish. Ethical consideration The purpose of the present study will be explained to both the parents and children and informed consents will be obtained as well as ascents from children .The researcher will be obligated to do dental treatment for every child according to his-her condition as compensation according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University. Materials to be used in the study: Materials Composition Manufacture Trade names Fluoride varnish 5% sodium fluoride (22.600ppm) Dentkist-korea Charm varnish R Self-assembling peptide p11-4 Sodium Fluoride 0.05% Water,Chlorhexidine digluconate,Tromethamine, Trehalose Dihydrate, Oligopeptide-104, HydroxyPropyl MethylCellulose,Citric Acid,Sodium Hydroxide Credentis AG, Windisch, Switzerland CURODONT Repair ™ fluoride plus Polishing paste fluoride free Titanium Oxide Crosstex- Chicago,US Sparkle Free Prophy Paste Methods 1. Clinical examination and assessments: * Full dental and medical history for the children will be recorded in the child chart. * Children will be examined under reflector light conditions using sterile mirrors and blunt end probes with compressed air. * Labial surface of one anterior tooth in each child will be cleaned and plaque debris will be removed using a prophylaxis paste fluoride free and a polishing brush 20,21,. * Early enamel carious Lesions will be assessed according to the International Caries Detection and Assessment System (ICDAS II; ranging between 1-3) and Laser fluorescence (LF) measurements DIAGNOdent\* will be conducted and values will be recorded as baseline data22,23. 2. Clinical procedure: * The selected teeth will be isolated with rubber dam. * The labile surface of the teeth will be gently cleaned and dried with air syringe. * In Group I: Self-assembling peptide (P11-4) fluoride plus will be applied according to the manufacturer's instructions by pushing the two cylinders together and will left for 5 min till the tooth surface appears dry to insure its diffusion 15. * In Group II: Fluoride varnish will be applied under manufacturer instructions by applying thin layer of varnish with a brush in strokes 24. In all groups children will be advised to: * Not to rinse his or her mouth, eat, or drink for at least 30 minutes after the treatment, only soft food and drink can be consumed in the day of treatment 22. * The children use a soft toothbrush and fluoridated toothpaste as an oral hygiene regimen23. 3. Evaluation: The remineralizing process of the early enamel carious lesions will be assessed qualitatively using ICDAS II scoring system (table 1) and quantitatively using the laser fluorescence DIAGNOdent measuring at baseline 1, 3, 6 months post-treatment

Conditions

• White Spot Lesion

Interventions

Type	Name	Description
DRUG	self assembling peptide p11-4 with fluoride	Self-assembling peptide (P11-4) fluoride plus will be applied according to the manufacturer's instructions by pushing the two cylinders together and will left for 5 min till the tooth surface appears dry to insure its diffusion The remineralizing process of the early enamel carious lesions will be assessed quantitatively using the laser fluorescence DIAGNOdent measuring and assessed qualitatively using ICDAS II scoring system at baseline 1, 3, 6 months post-treatment
DRUG	5% sodium fluoride varnish	Fluoride varnish will be applied under manufacturer instructions by applying thin layer of varnish with a brush in strokes The remineralizing process of the early enamel carious lesions will be assessed quantitatively using the laser fluorescence DIAGNOdent measuring and assessed qualitatively using ICDAS II scoring system at baseline 1, 3, 6 months post-treatment

Timeline

• Start date: 2024-06-06
• Primary completion: 2024-11-06
• Completion: 2025-01-06
• First posted: 2024-04-10
• Last updated: 2024-05-23

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study