Ignite Creation Date:
2025-12-18 @ 8:13 AM
Ignite Modification Date:
2025-12-23 @ 6:13 PM
Study NCT ID:
NCT06821724
Status:
None
Last Update Posted:
2025-02-12 00:00:00
First Post:
2025-02-06 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Different Remineralizing Agents on White Spot Lesions Treatment in Children
Sponsor:
None
Organization:
Study Overview
Official Title:
Comparative Study on the Effect of Different Remineralizing Agents Versus Fluoride Gel on White Spot Lesions After In-Office Followed by Home Treatment in Children: A Randomized Controlled Clinical Study
Status:
None
Status Verified Date:
2025-02
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:
RCT
Brief Summary:
Children having at least one tooth clinically diagnosed by white spot lesion were randomly allocated to five groups.
Group one: No treatment was applied (negative control). Group two: Fluoride gel was applied for 5 minutes (positive control). Group three: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) was applied for 5 minutes.
Group four: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) were applied for 5 minutes.
Group five: Nano hydroxyapatite paste (Apagard primo toothpaste) was be applied for 5 minutes.
All children involved in this study were instructed to brush their teeth under the supervision of the researcher before the application of the studied agent.
Each agent was applied to the labial surfaces of each tooth affected with white spot lesion for 5 minutes after cleaning and drying with a cotton roll using an applicator tip. After each application, children were instructed not to eat or drink for one hour. This application was be repeated in-office after one then after two weeks then after six weeks.
Participants received a sterilized pouch containing a sterile container with one of the pastes according to the study group for home application. The application of the paste was carried out under parental supervision and was asked to apply each of the pastes at home three times a day till the end of the study
Group one: No treatment was applied (negative control). Group two: Fluoride gel was applied for 5 minutes (positive control). Group three: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) was applied for 5 minutes.
Group four: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) were applied for 5 minutes.
Group five: Nano hydroxyapatite paste (Apagard primo toothpaste) was be applied for 5 minutes.
All children involved in this study were instructed to brush their teeth under the supervision of the researcher before the application of the studied agent.
Each agent was applied to the labial surfaces of each tooth affected with white spot lesion for 5 minutes after cleaning and drying with a cotton roll using an applicator tip. After each application, children were instructed not to eat or drink for one hour. This application was be repeated in-office after one then after two weeks then after six weeks.
Participants received a sterilized pouch containing a sterile container with one of the pastes according to the study group for home application. The application of the paste was carried out under parental supervision and was asked to apply each of the pastes at home three times a day till the end of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: