Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05485272
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2022-07-30
Brief Title:
Clinical Evaluation of SDF Combined With KI Versus SDF in Management of Class I Carious Lesions
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Clinical Evaluation of Silver Diamine Fluoride Combined With Potassium Iodide Versus Silver Diamine Fluoride in Management of Class I Carious Lesions Over a Period of 12 Months Follow-up A Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
To evaluate the clinical performance of High-Viscosity Glass Ionomer EQUIA versus Silver Diamine Fluoride combined with Potassium Iodide Riva Star and Sliver Diamine Fluoride SDF under High-Viscosity Glass Ionomer EQUIA in deep class I carious lesions over a period of one year follow-up The null hypothesis tested in this study that in deep class I carious lesions the High-Viscosity Glass Ionomer EQUIA versus Silver Diamine Fluoride combined with Potassium Iodide Riva Star and Sliver Diamine Fluoride SDF under High-Viscosity Glass Ionomer EQUIA will show the same clinical performance
Detailed Description:
A sample of adults with an age range of 18-40 years old having a permanent molar with deep class I carious lesions according to the international caries detection and assessment system ICDAS occlusal caries that scored 4 underlying dark shadow from dentin or 5 Distinct cavity with visible dentin will be selected from the patients attending at the Conservative and Esthetic Dentistry Department Clinic Faculty of Dentistry Cairo University and those who meet the study inclusion criteria will be recruited
All selected 42 permanent molars will be randomly equally allocated into three groups according to the material used Group I n14 Silver Diamine Fluoride combined with Potassium Iodide Riva Star under High-Viscosity Glass Ionomer EQUIA Group II n14 Silver Diamine Fluoride SDF both under High-Viscosity Glass Ionomer EQUIA and Group III n14 High-Viscosity Glass Ionomer EQUIA
Steps in Short
1 Recruitment of the patients and full examination with diagnosis
2 Informed consent taking for the eligible participants to participate in the study
3 Randomization and allocation into three groups
4 Application of the intervention 1 Silver Diamine Fluoride combined with Potassium Iodide Riva Star Intervention 2 Silver Diamine Fluoride SDF Both under High-Viscosity Glass Ionomer EQUIA The comparator High-Viscosity Glass Ionomer EQUIA All materials were manipulated according to the manufacturers instructions
5 Baseline data collection of the clinical evaluation of the restorations using FDI criteria
6 Follow up at 3 6 and 12 months for data collection of the clinical evaluation of the restorations using FDI criteria
All selected 42 permanent molars will be randomly equally allocated into three groups according to the material used Group I n14 Silver Diamine Fluoride combined with Potassium Iodide Riva Star under High-Viscosity Glass Ionomer EQUIA Group II n14 Silver Diamine Fluoride SDF both under High-Viscosity Glass Ionomer EQUIA and Group III n14 High-Viscosity Glass Ionomer EQUIA
Steps in Short
1 Recruitment of the patients and full examination with diagnosis
2 Informed consent taking for the eligible participants to participate in the study
3 Randomization and allocation into three groups
4 Application of the intervention 1 Silver Diamine Fluoride combined with Potassium Iodide Riva Star Intervention 2 Silver Diamine Fluoride SDF Both under High-Viscosity Glass Ionomer EQUIA The comparator High-Viscosity Glass Ionomer EQUIA All materials were manipulated according to the manufacturers instructions
5 Baseline data collection of the clinical evaluation of the restorations using FDI criteria
6 Follow up at 3 6 and 12 months for data collection of the clinical evaluation of the restorations using FDI criteria
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?:
False
Is an FDA AA801 Violation?:
None