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

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

Study Overview

• Status: Unknown
• Conditions: White Spot Lesion
• Intervention / Treatment: Drug: Self assembling peptide with fluoride

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omnia Amin, Master; Phone Number: 01272512839; Email: omniaamin232@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 00202
    • Faculty of Oral & Dental Medicine - Cairo University
    • Contact: Omnia Amin, Master; Phone Number: 01272512839; Email: omniaamin232@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Self assembling peptide with fluoride	Drug: Self assembling peptide with fluoride; 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; Other Names: Curodont Repair Fluoride Plus
ACTIVE_COMPARATOR: Casein-phosphopeptide/amorphous-calcium phosphate	Drug: Self assembling peptide with fluoride; 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; Other Names: Curodont Repair Fluoride Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralization potential	by: Inspection under magnification ICDAS II Score 0:Sound tooth surface: First visual change in enamel.; Distinct visual change in enamel visible when wet, lesion must be visible when dry.	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(

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralization potential	by: Image analysis software Change in area of the white spot lesion (mm2)	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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (ACTUAL): January 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: p11 4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No