Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions

NCT03823612 | Unknown Phase 4

• 1 other identifier: donia mahmoud
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

to remineralize the white spot caries lesions after orthodontic treatment , the investigator will use two different materials ( Clinpro tooth creme versus Gc tooth mousse) and will compare between their effects in remineralization of white spot caries lesions.

Conditions

White Spot Lesion of Tooth

Outcome Measures

Primary Outcomes (1)

• esthetic assessment

  Spectrophotometer ( L, a, b) will be used to measure the change in the shade of the white spot lesions during the study

  baseline, after 1 month , 3 months and 6 months of the application

Secondary Outcomes (1)

• patient compliance

  6 months

Study Arms (2)

GC tooth mousse

EXPERIMENTAL

Drug: GC tooth mousse it contains complex of Casein Phosphopeptide,Amorphous Calcium Phosphate ( CPP-ACP ) other name: Tooth Mousse (Bio-available calcium and phosphate, without fluoride)

Drug: GC tooth mousse

clinpro tooth creme

ACTIVE COMPARATOR

it contains 0.21% Sodium Fluoride, Anti-Cavity Paste is an advanced formula containing an innovative tri-calcium phosphate ingredient other name:0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

Drug: Clinpro Tooth Creme

Interventions

Clinpro Tooth Creme DRUG

The participant will be instructed to Place a pea-sized amount of Clinpro Tooth Crème on a soft bristled toothbrush and brush teeth for at least two minutes then after brushing the patient will rinse out his mouth with water and spit out. It will be used twice daily at first in the morning and before sleep.

Also known as: Anti-Cavity Paste with Tri-Calcium Phosphate

clinpro tooth creme

GC tooth mousse DRUG

The participant will be instructed to squeeze a small amount of GC Tooth Mousse out onto a clean finger. A cotton tip, swab or custom tray are suitable application methods as it will Applied directly onto his tooth surfaces and leave undisturbed for three minutes then he will be instructed to Spread any residual crème around the mouth with his tongue and hold for a further one to two minutes then the participant will expectorate thoroughly and if possible he should avoid rinsing. Any GC Tooth Mousse remaining in the mouth can be left to gradually dissipate. The participant will be instructed to avoid eating or drinking for 30 minutes following application.

GC tooth mousse

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients should have at least one white spot caries lesion
• age from 18 to 40 years
• no gender restriction

You may not qualify if:

• Patients with a compromised medical history.
• Severe or active periodontal disease
• Patients with developmental hypo-calcified lesions

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Donia Mahmoud Abd El Moaty

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator in cairo university

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: March 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

EG (1)