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

NCT04245787 | Unknown DMC

• 1 other identifier: p11 4
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (1)

• Remineralization potential

  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.

  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 Outcomes (1)

• 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

Study Arms (2)

Self assembling peptide with fluoride

EXPERIMENTAL

Drug: Self assembling peptide with fluoride

Casein-phosphopeptide/amorphous-calcium phosphate

ACTIVE COMPARATOR

Drug: Self assembling peptide with fluoride

Interventions

Self assembling peptide with fluoride DRUG

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

Also known as: Curodont Repair Fluoride Plus

Casein-phosphopeptide/amorphous-calcium phosphate; Self assembling peptide with fluoride

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty Of Oral & Dental Medicine - Cairo University

Cairo, 00202, Egypt

Location

MeSH Terms

Interventions

Fluorides

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Central Study Contacts

omnia amin, master

CONTACT

01272512839; omniaamin232@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at operative dentistry department, Cairo university

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: February 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

EG (1)