Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412731
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-25
Brief Title:
Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38 Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars
Sponsor:
Al-Mustansiriyah University
Organization:
Al-Mustansiriyah University
Study Overview
Official Title:
Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38 Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
This study aims to investigate the efficacy of silver diamine fluoride SDF and Papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children by investigating the following outcomes
1 Arrestment of caries lesion and the emergence of a new one
2 Time required for the treatment
3 Adverse events
4 Childrens anxiety
1 Arrestment of caries lesion and the emergence of a new one
2 Time required for the treatment
3 Adverse events
4 Childrens anxiety
Detailed Description:
The traditional approach to removing caries with dental burs is the most often used technique in the treatment of dental caries However this method is continuously associated with many disadvantages such as patients finding drilling uncomfortable the frequent need for local anesthetic and detrimental heat effects on the pulp
The purpose of this research was to evaluate three minimally invasive therapies via the assessment of
1 Duration of treatment
2 feeling of pain and the need for anesthetic
3 Incidents with negative outcomes that have been officially documented
4 Filling material adhesiveness fellow up
The null hypothesis was that there was no difference among Silver Diamine Fluoride Brix3000 Papain based Chemico-mechanical caries removal product and ceramic burr in time anxiety and pain reported side effect
Randomized control clinical trial will be allocated into 3 groups S group treatment with SDF B group treatment with Brix3000 Papain based gel and C group as control treatment by rotary handpiece Smart bur
Setting
Sample collection the samples are to be collected at The College of Dentistry Al-Mustansiriyah University - Iraq- Baghdad Subject The sample size will be 45 children aged 7-8 years with primary molars with occlusal active caries lesions
The purpose of this research was to evaluate three minimally invasive therapies via the assessment of
1 Duration of treatment
2 feeling of pain and the need for anesthetic
3 Incidents with negative outcomes that have been officially documented
4 Filling material adhesiveness fellow up
The null hypothesis was that there was no difference among Silver Diamine Fluoride Brix3000 Papain based Chemico-mechanical caries removal product and ceramic burr in time anxiety and pain reported side effect
Randomized control clinical trial will be allocated into 3 groups S group treatment with SDF B group treatment with Brix3000 Papain based gel and C group as control treatment by rotary handpiece Smart bur
Setting
Sample collection the samples are to be collected at The College of Dentistry Al-Mustansiriyah University - Iraq- Baghdad Subject The sample size will be 45 children aged 7-8 years with primary molars with occlusal active caries lesions
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