Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial

Not Applicable

• Conditions: White Spot Lesion
• Interventions: Drug: Self assembling peptide with fluoride

• Registration Number: NCT04245787
• Lead Sponsor: Cairo University

Brief Summary

The goal of modern dentistry is to manage non-cavitated caries lesions non- invasively through re-mineralization process to prevent the disease progression and improve aesthetics, strength, and function. Re-mineralization is defined as the process that supplies calcium, phosphate and flouride ions from an external source to the tooth to convert ion deposition into crystal voids in demineralized enamel. White spot lesions should be managed using a multifactorial approach. The most important strategy is to prevent demineralization and biofilm formationand use of methodologies for remineralization of lesions .

Self-assembling peptide (P11-4) has shown great potential for natural repair of early caries lesions through emerging biomimetic re-mineralization properties. (Takahashi Fet al in 2015) This peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-27
• Last Update Submitted: 2020-01-27
• Study First Posted: 2020-01-29
• Last Update Posted: 2020-01-29
• Study Start: 2020-02
• Primary Completion: 2020-03
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Between the ages of 18 and 35 years of age female and males
• Had received conventional periodontal therapy
• Active carious white spot lesions
• No systemic diseases or concomitant medication affecting salivary flow

Exclusion Criteria

• • Participant in another trial
• Non carious lesion (enamel hypoplasia and dental flourosis)
• Presence of abnormal oral, medical, or mental condition.
• Participants who had evidence of reduced salivary flow or significant tooth wear.
• Allergy to MI paste

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self assembling peptide with fluoride	Self assembling peptide with fluoride	-
Casein-phosphopeptide/amorphous-calcium phosphate	Self assembling peptide with fluoride	-

Primary Outcome Measures

Name	Time	Method
Remineralization potential	T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months Assessment of white spot lesion regres(	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.

Secondary Outcome Measures

Name	Time	Method
Remineralization potential	T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months( Assessment of white spot lesion regres	by: Image analysis software Change in area of the white spot lesion (mm2)

Trial Locations

Locations (1)

Faculty Of Oral & Dental Medicine - Cairo University; 🇪🇬 Cairo, Egypt