Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776785
Status:
COMPLETED
Last Update Posted:
2021-03-12
First Post:
2021-02-27
Brief Title:
Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries
Sponsor:
Izmir Katip Celebi University
Organization:
Izmir Katip Celebi University
Study Overview
Official Title:
Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this randomized controlled double-blinded split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide P11-4 solution Curodont Repair with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate CPP-ACP with fluoride varnish MI Varnish sodium fluoride NaF varnish Profluorid Varnish
The study included 300 permanent molars belonging to 150 children aged between 7 to 13 years old who had two non-cavitated proximal carious lesions
The study included 300 permanent molars belonging to 150 children aged between 7 to 13 years old who had two non-cavitated proximal carious lesions
Detailed Description:
First the subjects were randomly allocated to three main groups with 50 individuals in each Then the carious lesions belonging to each subject were randomly assigned to two subgroups based on different treatment agents used Group 1 P11-4NaFNaF Group 2 P11-4NaFCPP-ACPNaF Group 3 CPP-ACPNaFNaF Accordingly test 1 lesions received P11-4NaF combination test 2 lesions received CPP-ACPNaF varnish and control lesions received NaF varnish alone At the 6th and 12th months after the clinical applications Profluorid Varnish application was repeated for test 1 and control lesions and MI Varnish application was repeated for test 2 lesions At the end of the 12 months carious lesion progression status was evaluated radiographically by using independent visual reading pair-wise visual reading and digital subtraction radiography DSR methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None