The Remineralization of Early Enamel Caries in Permanent Teeth

NCT06358066 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: self assembling peptides
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Remineralization

Outcome Measures

Primary Outcomes (1)

• Remineralization potential

  T0:baseline assessment --\> T1:1 month(Application of Curodont repair flouride plus /fluoride varnish andAssessment of white spot lesion regression)--\> T2: 3 months Assessment of white spot lesion regression\_\_\>T3: 6 months assessment of white spot lesion regression by: Inspection under magnification ICDAS II Score 0:Sound tooth surface: 1. First visual change in enamel. 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry. by:Diagnodent

  1 month

Secondary Outcomes (1)

• Remineralization potential

  3 months

Study Arms (2)

curodont repair fluoride plus

EXPERIMENTAL

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

Drug: self assembling peptide p11-4 with fluoride

fluoride varnish

ACTIVE COMPARATOR

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

Drug: 5% sodium fluoride varnish

Interventions

self assembling peptide p11-4 with fluoride DRUG

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

Also known as: curodont repair fluoride plus varnish

curodont repair fluoride plus

5% sodium fluoride varnish DRUG

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

Also known as: charm fluoride varnish

fluoride varnish

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• No systemic diseases or medication affecting salivary flow.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of Dentistry,Tanta university

Tanta, 31511, Egypt

Location

MeSH Terms

Interventions

Fluorides; Paint

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Sara Elgebaly, master

CONTACT

01023306741; sarah.elgebaly276@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 10, 2024
• Study Start: June 6, 2024
• Primary Completion: November 6, 2024
• Study Completion: January 6, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months

Locations

EG (1)