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The Remineralization of Early Enamel Caries in Permanent Teeth

NCT06358066 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-23

No results posted yet for this study

Summary

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

Conditions

  • White Spot Lesion

Interventions

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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-06
Primary Completion
2024-11-06
Completion
2025-01-06
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06358066 on ClinicalTrials.gov