Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545279
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-09
Brief Title:
The Success Rate and Acceptability of Conventional and Modified Hall Crowns Among Children and Parents
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Success Rate Child and Parent Acceptance of Modified Hall Crowns Versus Conventional Hall CrownsA Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hallcrowns
Brief Summary:
This is a clinical trial that aims to compare the success rate child and parent acceptance of conventional Hall crown technique CHT to modified Hall crown technique MHTin treating carious primary molars Eligible children will receive CHT on one side and MHT on the other side The time interval between both visits will be 1-2 weeksPatients demographics and pain history will be recorded and pre-operative radiographs will be taken An observer will assess and record the childs pain perception during each treatment visit Time taken for each procedure will be recorded by the research assistant each visit prospectively from the moment the child sits on the dental chair till the end of procedure Parental preference and child acceptance for each procedure will be recorded after treatment is finished using parent and child questionnaire Clinical follow up will be conducted at 36 and 12 months to assess and compare the success rates of both techniques Radiographs will be taken at 12 months to evaluate and compare radiographic success
Detailed Description:
This is a split mouth randomized clinical trial that aims to compare the success rate child and parent acceptance of conventional Hall crown technique CHT to modified Hall crown technique MHTin treating carious primary molars Eligible children will receive CHT on one side and MHT on the other side The time interval between both visits will be 1-2 weeksPatients demographics and pain history will be recorded and pre-operative bitewings will be taken An observer research assistant who will be trained calibrated and blinded to the treatment used will assess and record the childs pain perception during treatment visit Time taken for each procedure will be recorded by the research assistant each visit prospectively from the moment the child sits on the dental chair till the end of procedure Parental preference and child acceptance for each procedure will be recorded after treatment is finished using parent and child questionnaire Clinical follow up will be conducted at 36 and 12 months to assess and compare the success rates of both techniquesBitewings will be taken at 12 months to assess for crown fit and radiographic pathology
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?:
None