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

NCT ID: NCT04245787

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-29
• Study Completion Date: 2020-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self assembling peptide with fluoride

Group Type: EXPERIMENTAL

Self assembling peptide with fluoride

Intervention Type: 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

Casein-phosphopeptide/amorphous-calcium phosphate

Group Type: ACTIVE_COMPARATOR

Self assembling peptide with fluoride

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Curodont Repair Fluoride Plus

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nada Hamada Ahmed Shehab Eldin

resident at operative dentistry department, Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty Of Oral & Dental Medicine - Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

omnia amin, master

Role: CONTACT

omniaamin232@gmail.com

01272512839

Facility Contacts

Omnia Amin, Master

Role: primary

omniaamin232@gmail.com

01272512839

Other Identifiers

p11 4

Identifier Type: -

Identifier Source: org_study_id