Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions

Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions Among a Group of Egyptian Children : A Randomized Clinical Trial

The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.

Study Overview

• Status: Not yet recruiting
• Conditions: Remineralization
• Intervention / Treatment: Drug: Monomeric self - assembling peptide P11-4; Drug: Tricalcium phosphate fluoride varnish, 5% F-; Drug: fluoride varnish (5% sodium fluoride)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yara A Abdellatif, BDS; Phone Number: 00201007627551; Email: yaraabdellatif@dentistry.cu.edu.eg
• Study Contact Backup: Name: Rasha Hatem, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Apparently healthy cooperative children
• Aging from 3-5 years old child
• Both genders
• Primary teeth with active WSLs on buccal or labial surfaces
• Patient and parent acceptance to treatment and maintenance of good oral hygiene

Exclusion Criteria:

• Restored teeth
• White spot lesions due to fluorosis
• Teeth with hypoplasia
• Lesions that require an invasive treatment
• Any pathology or concomitant medication affecting salivary flow or causing dry mouth

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Curodont Repair® ( monomeric self - assembling peptide P11-4 ); Self assembling peptide P11-4 as Curodont Repair® can remineralize WSLs in a deeper manner than fluoride by guided enamel regeneration by forming a three-dimensional matrix within the subsurface body of an initial carious lesion to which calcium and phosphate ions found in natural saliva can bind and build de novo hydroxyapatite crystals.	Drug: Monomeric self - assembling peptide P11-4; Monomeric self - assembling peptide P11-4 ( Curodont Repair ) is a remineralizing agent applied on tooth surface after treating it with 3% sodium hypochlorite for 20 seconds then etching it with 37% phosphoric acid for 20 seconds followed by rinsing then dryness.; Other Names: Curodont Repair
EXPERIMENTAL: Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- ); Tri-calcium phosphate can be hydrolyzed rapidly to form calcium hydroxyapatite (HAp). The processes of hydrolysis and formation of HAp are accelerated by the presence of NaF ions as in case of Clinpro white varnish®. Moreover, the HAp formed by such hydrolysis tends to have a greater uptake of fluoride than conventional HAp.	Drug: Tricalcium phosphate fluoride varnish, 5% F-; Tricalcium phosphate fluoride varnish, 5% F- ( Clinpro White Varnish ) is a remineralizing agent applied on tooth surface after mixing it with a brush onto the dosage guide.; Other Names: 3M Clinpro white varnish
ACTIVE_COMPARATOR: Voco-profluorid® fluoride varnish (5% sodium fluoride); Fluoride varnish is the gold standard for treating WSLs.	Drug: fluoride varnish (5% sodium fluoride); fluoride varnish (5% sodium fluoride) ( Voco-profluorid ) is a remineralizing agent applied on tooth surface then area is allowed to become wet (either by gentle rinsing or natural salivary flow) to ensure setting of VOCO Profluorid Varnish.; Other Names: Voco-profluorid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of WSL ( white spot lesion )	Size of WSL measured by scored dental probe	through study completion, an average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regression of caries	Regression of caries evaluated by International Caries Detection and Assessment System (ICDAS) II	through study completion, an average of 8 months
Inactivation of active carious lesions	Inactivation of active carious lesions evaluated by Lesion activity assessment (LAA-ICDAS)	through study completion, an average of 8 months
Mineral content of WSL	Mineral content of WSL measured by fluorescence camera VistaCam iX	through study completion, an average of 8 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (ACTUAL): October 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: 257

Drug and device information, study documents

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