Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions

Phase 4

• Conditions: White Spot Lesion of Tooth
• Interventions: Drug: GC tooth mousse; Drug: Clinpro Tooth Creme

• Registration Number: NCT03823612
• Lead Sponsor: Cairo University

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.

Detailed Description

Dental caries is the localized destruction of tooth tissues by acids, especially lactic acid, produced by the fermentation of dietary carbohydrates by bacteria in dental plaque. Demineralization can be arrested or reversed when remineralization agents are applied to incipient carious or non-cavitated carious lesions. A large number of therapeutic agents including non-fluoridated products have been developed to promote enamel remineralization. The process of restoring lost mineral ions to the tooth structure and strengthening the lattice work is known as remineralization.

The development of decalcification around orthodontic brackets and bands, commonly called white spot lesions (WSLs), is often observed in patients with poor oral hygiene during treatment .In many instances, these WSLs continue to be visible after the removal of fixed appliances and after natural remineralization. The remineralized enamel crystallites are generally more resistant to decalcification and also have the same orientation as the original enamel crystallites. The early enamel lesions have a potential for remineralization with an increased resistance to further acid challenge, particularly with the use of enhanced remineralization treatments.

Recaldent™ is derived from the milk protein, casein. For many years it has been known that milk and its derivatives have a tooth protective effect. Research has shown that this activity is due to a part of the casein protein called Casein Phosphopeptide (or CPP), which carries calcium and phosphate ions in the form of Amorphous Calcium Phosphate (or ACP) which used in reminerlization of white spot caries lesions.

Clinpro tooth crème (3M ESPE) is a 0.21% w/w sodium fluoride (NaF) anti caries dentifrice that contains 950 ppm fluoride and a functionalized tricalcium phosphate (f-TCP) ingredient.One major advantage of this calcium phosphate system is that it is stable in aqueous environment and also does not affect the fluoride activity added in the dentifrices. Furthermore,it has been suggested that fluoride combination with f-TCP not only provides greater remineralization in terms of microhardness and fluoride uptake, but also decreases the dose of fluoride required to achieve the same degree of remineralization,

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Study First Posted: 2019-01-30
• Last Update Posted: 2019-01-30
• Study Start: 2019-03-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GC tooth mousse	GC tooth mousse	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)
clinpro tooth creme	Clinpro Tooth Creme	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

Primary Outcome Measures

Name	Time	Method
esthetic assessment	baseline, after 1 month , 3 months and 6 months of the application	Spectrophotometer ( L, a, b) will be used to measure the change in the shade of the white spot lesions during the study

Secondary Outcome Measures

Name	Time	Method
patient compliance	6 months	The participants compliance will be detected by a questionnaire by asking the patient to describe his satisfaction to the total outcome of our intervention by giving a score from 1-10

Trial Locations

Locations (1)

Donia Mahmoud Abd El Moaty; 🇪🇬 Cairo, Egypt