Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350578
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-24
Brief Title:
A Randomized Clinical Trial Comparing Hall vs Conventional Technique in Primary Molars
Sponsor:
Primary Health Care Corporation Qatar
Organization:
Primary Health Care Corporation Qatar
Study Overview
Official Title:
Comparative Analysis of Hall Technique and Conventional Method for Stainless Steel Crown Placement in Primary Molars With Approximal Caries A Randomized Controlled Trial at Primary Healthcare Corporation Qatar
Status:
RECRUITING
Status Verified Date:
2024-04
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 assess the comparative effectiveness of the Hall technique HT and the conventional technique CT for placing Stainless Steel Crowns SSCs in primary molars with approximal caries
Detailed Description:
Background The most common chronic disease in children and adolescents 6-19 years old is dental caries The conventional approach of carious lesions treatment involves cavity preparation with rotary instruments restoration with composite resin amalgam or stainless-steel crowns SSCs
Retrospective studies showed that SSCs have a better success rate compared to amalgam or resin-based restorations when used for multi-surface caries in primary teeth Hence the American Academy of Paediatric Dentistry AAPD recommended the use of SSCs as the treatment of choice for carious lesions of more than one surface in high-risk children
Recently the Hall technique HT has been used for sealing caries in primary molars The contemporary technique was first introduced in the literature in 2006 by Dr Norna Hall while she was working in a high caries-risk area in rural Scotland The technique has straightforward biological principles where the most important layer for the caries progression in the biofilm which is the superficial plaque layer is left and sealed along with the carious lesion Consequently a less cariogenic flora will be composed in the plaque biofilm thus arresting or slowing down the caries progression in primary teeth The Hall technique HT involves cementing SSC on carious primary teeth without using rotary instruments nor local anaesthesia thus eliminating discomfort and increasing childs behaviour
Aim This study aims to assess the comparative effectiveness of the Hall technique HT and the conventional technique CT for placing Stainless Steel Crowns SSCs in primary molars with approximal caries
MethodsDesign
The study will compare between the hall technique HT and the conventional restoration CR using stainless steel crowns SSCs in terms of technique acceptability parents childrens behavior and the perception of pain Approximal dental caries ICDAS 3-5 in primary molars of children 3-9 years old will be managed by two treatment techniques conventional restorations CR using stainless steel crowns SSCs and the hall technique HT
The study will be a binary outcome non-inferiority randomized trial with treatment provided in a primary care dental clinic setting The study protocol will be written following Consolidated Standards of Reporting Trials CONSORT guidelines for randomized trials of non-pharmacologic treatment Participants will be allocated randomly to be treated with SSCs placed with conventional technique CT control group or the HT experimental group in order to compare different options for arresting occlusal-proximal caries lesions in primary molars
Discussion The clinical trial seeks to provide evidence on whether Hall technique demonstrate comparable or superior clinical outcomes compared to conventional restorations in terms of childrens pain perception and cooperation in dental setting and parents acceptability as well
Retrospective studies showed that SSCs have a better success rate compared to amalgam or resin-based restorations when used for multi-surface caries in primary teeth Hence the American Academy of Paediatric Dentistry AAPD recommended the use of SSCs as the treatment of choice for carious lesions of more than one surface in high-risk children
Recently the Hall technique HT has been used for sealing caries in primary molars The contemporary technique was first introduced in the literature in 2006 by Dr Norna Hall while she was working in a high caries-risk area in rural Scotland The technique has straightforward biological principles where the most important layer for the caries progression in the biofilm which is the superficial plaque layer is left and sealed along with the carious lesion Consequently a less cariogenic flora will be composed in the plaque biofilm thus arresting or slowing down the caries progression in primary teeth The Hall technique HT involves cementing SSC on carious primary teeth without using rotary instruments nor local anaesthesia thus eliminating discomfort and increasing childs behaviour
Aim This study aims to assess the comparative effectiveness of the Hall technique HT and the conventional technique CT for placing Stainless Steel Crowns SSCs in primary molars with approximal caries
MethodsDesign
The study will compare between the hall technique HT and the conventional restoration CR using stainless steel crowns SSCs in terms of technique acceptability parents childrens behavior and the perception of pain Approximal dental caries ICDAS 3-5 in primary molars of children 3-9 years old will be managed by two treatment techniques conventional restorations CR using stainless steel crowns SSCs and the hall technique HT
The study will be a binary outcome non-inferiority randomized trial with treatment provided in a primary care dental clinic setting The study protocol will be written following Consolidated Standards of Reporting Trials CONSORT guidelines for randomized trials of non-pharmacologic treatment Participants will be allocated randomly to be treated with SSCs placed with conventional technique CT control group or the HT experimental group in order to compare different options for arresting occlusal-proximal caries lesions in primary molars
Discussion The clinical trial seeks to provide evidence on whether Hall technique demonstrate comparable or superior clinical outcomes compared to conventional restorations in terms of childrens pain perception and cooperation in dental setting and parents acceptability as well
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