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

NCT ID: NCT05064137

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-01-31

Brief Summary

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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

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Conditions

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Remineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Double blinded ( participant and statistician )

Study Groups

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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.

Group Type EXPERIMENTAL

Monomeric self - assembling peptide P11-4

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Tricalcium phosphate fluoride varnish, 5% F-

Intervention Type DRUG

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.

Voco-profluorid® fluoride varnish (5% sodium fluoride)

Fluoride varnish is the gold standard for treating WSLs.

Group Type ACTIVE_COMPARATOR

fluoride varnish (5% sodium fluoride)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Curodont Repair 3M Clinpro white varnish Voco-profluorid

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yara Ahmed Ibrahim Abdellatif

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yara A Abdellatif, BDS

Role: CONTACT

00201007627551

Rasha Hatem, PHD

Role: CONTACT

Other Identifiers

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257

Identifier Type: -

Identifier Source: org_study_id

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