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

NCT05064137 | Unknown

• 1 other identifier: 257
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Remineralization

Outcome Measures

Primary Outcomes (1)

• Size of WSL ( white spot lesion )

  Size of WSL measured by scored dental probe

  through study completion, an average of 8 months

Secondary Outcomes (3)

• Regression of caries

  through study completion, an average of 8 months

• Inactivation of active carious lesions

  through study completion, an average of 8 months

• Mineral content of WSL

  through study completion, an average of 8 months

Study Arms (3)

Curodont Repair® ( monomeric self - assembling peptide P11-4 )

EXPERIMENTAL

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

Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- )

EXPERIMENTAL

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-

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

ACTIVE COMPARATOR

Fluoride varnish is the gold standard for treating WSLs.

Drug: fluoride varnish (5% sodium fluoride)

Interventions

Monomeric self - assembling peptide P11-4 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.

Also known as: Curodont Repair

Curodont Repair® ( monomeric self - assembling peptide P11-4 )

Tricalcium phosphate fluoride varnish, 5% F- 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.

Also known as: 3M Clinpro white varnish

Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- )

fluoride varnish (5% sodium fluoride) 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.

Also known as: Voco-profluorid

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

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Sodium Fluoride

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Yara A Abdellatif, BDS

CONTACT

00201007627551; yaraabdellatif@dentistry.cu.edu.eg

Rasha Hatem, PHD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double blinded ( participant and statistician )
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 1, 2021
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 8, 2022

Record last verified: 2022-02