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

Remineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05064137
• Other study ID #: 257
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: January 2023

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: Yara A Abdellatif, BDS
• Phone: 00201007627551
• Email: yaraabdellatif[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Remineralization

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of WSL ( white spot lesion )	Size of WSL measured by scored dental probe	through study completion, an average of 8 months
Secondary	Regression of caries	Regression of caries evaluated by International Caries Detection and Assessment System (ICDAS) II	through study completion, an average of 8 months
Secondary	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
Secondary	Mineral content of WSL	Mineral content of WSL measured by fluorescence camera VistaCam iX	through study completion, an average of 8 months