Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05206539
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-01-12
Brief Title:
Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
Sponsor:
Plovdiv Medical University
Organization:
Plovdiv Medical University
Study Overview
Official Title:
Efficacy of Self-assembling Peptide P11-4 Casein Phosphopeptide - Amorphous Calcium Fluoride Phosphate and Resin Infiltrant in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
Status:
RECRUITING
Status Verified Date:
2024-02
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:
White spot lesions WSL are characterized by an apparently intact outer surface and a demineralized subsurface and are considered the first clinical sign of dental caries
Aim of this study is to determine the treatment potential of self-assembling peptide P11-4 casein phosphopeptide-amorphos calcium fluoride phosphate CPP-ACFP and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients using visual assessments and laser fluorescence investigation
Aim of this study is to determine the treatment potential of self-assembling peptide P11-4 casein phosphopeptide-amorphos calcium fluoride phosphate CPP-ACFP and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients using visual assessments and laser fluorescence investigation
Detailed Description:
White spot lesions WSL are characterized by an apparently intact outer surface and a demineralized subsurface and are considered the first clinical sign of dental caries These lesions are characterized by white chalky appearance As caries is reversible under favorable conditions many approaches have focused on treating it as soon as possible1
Aim of this study is to determine the treatment potential of self-assembling peptide P11-4 casein phosphopeptide-amorphos calcium fluoride phosphate CPP-ACFP and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients This will be achieved using visual assessments and laser fluorescence investigation
The proposed study is a randomized controlled clinical trial with split-mouth design Included are forty positive patients aged 9-17 years with at least four visible WSL on smooth surfaces in permanent teeth requiring non-operative treatment WSL will be assessed visually by ICDAS II Nyvad criteria and laser fluorescence LF pen The lesions are randomly assigned into 4 groups n 40 Gr NT no treatment control group Gr CR Curodont Repair Gr V MI Varnish Gr I Icon groups Lesions will be assessed by International Caries Detection and Assessment System Nyvad caries activity criteria and laser fluorescence at baseline and follow-up period after1 3 6 and 12 months
Data will be analyzed with intention-to-treat concept by Student T-test for paired samples Wilcoxon signed rank test P 05 Pre-test on 20 subjects resulted in n41 patients sample size
Aim of this study is to determine the treatment potential of self-assembling peptide P11-4 casein phosphopeptide-amorphos calcium fluoride phosphate CPP-ACFP and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients This will be achieved using visual assessments and laser fluorescence investigation
The proposed study is a randomized controlled clinical trial with split-mouth design Included are forty positive patients aged 9-17 years with at least four visible WSL on smooth surfaces in permanent teeth requiring non-operative treatment WSL will be assessed visually by ICDAS II Nyvad criteria and laser fluorescence LF pen The lesions are randomly assigned into 4 groups n 40 Gr NT no treatment control group Gr CR Curodont Repair Gr V MI Varnish Gr I Icon groups Lesions will be assessed by International Caries Detection and Assessment System Nyvad caries activity criteria and laser fluorescence at baseline and follow-up period after1 3 6 and 12 months
Data will be analyzed with intention-to-treat concept by Student T-test for paired samples Wilcoxon signed rank test P 05 Pre-test on 20 subjects resulted in n41 patients sample size
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