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

Not Applicable

• Conditions: Remineralization
• Interventions: Drug: Monomeric self - assembling peptide P11-4; Drug: Tricalcium phosphate fluoride varnish, 5% F-; Drug: fluoride varnish (5% sodium fluoride)

• Registration Number: NCT05064137
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-18
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-21
• Study Start: 2022-03
• Last Update Posted: 2022-03-08
• Primary Completion: 2022-12
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curodont Repair® ( monomeric self - assembling peptide P11-4 )	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.
Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- )	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.
Voco-profluorid® fluoride varnish (5% sodium fluoride)	fluoride varnish (5% sodium fluoride)	Fluoride varnish is the gold standard for treating WSLs.

Primary Outcome Measures

Name	Time	Method
Size of WSL ( white spot lesion )	through study completion, an average of 8 months	Size of WSL measured by scored dental probe

Secondary Outcome Measures

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