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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05064137
Other study ID # 257
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04422860 - Remineralization Efficacy of Gum Arabic Varnish. Phase 2/Phase 3
Not yet recruiting NCT05306691 - Remineralizing Efficacy of Giomer Varnish vs. Fluoride Varnish in Management of White Spot Lesions in Adult Patients Early Phase 1
Completed NCT04124887 - Remineralization Effect of Fluoride Varnishes on Permanent Molars N/A
Completed NCT06178042 - Effectiveness of MI Paste Plus and Remin Pro on Remineralization of Post-Orthodontic White Spot Lesions N/A