Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592885
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Comparing Minimally Invasive Techniques Used in Treatment of Carious Primary Molars in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Success of Hall Technique Versus Atraumatic Restorative Treatment in the Management of Carious Primary Molars a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Dental caries is a natural process by which bacteria in the biofilm causes fluctuations in the pH which leads to enamel erosion and result in visible lesions If left untreated caries will progress and result in pain abscess and systemic infection leading to functional andor psychosocial impairment which is a serious problem Caries is in fact the most prevalent childhood disease in the world and is most prominent among low-economic populations So the main goal is to minimize Dental caries as much as possible by applying preventive measures to reduce the occurrence and progression of dental caries
In that scope both Atraumatic Restorative Treatment ART and the Hall Technique HT were created as part of Minimal Invasive Dentistry MID to slow the downward restorative spiral and reduce discomfort during the treatment as neither of which requires the administration of local anesthesia nor the use of rotary instruments
According to a retrospective analysis utilizing the Hall technique to seal cavities performed much better than using conventional restorations statistically and clinically during 10 years of follow-up
Since ART is associated with lower levels of anxiety pain and discomfort than traditional dentistry procedures it has become widely employed in pediatric dentistry Despite having reduced survival rates in multiple-surface restorations ART is still regarded as a viable evidence-based choice for treating and preventing caries lesions in primary posterior teeth since it is a quick inexpensive and comfortable procedure for the patient
In that scope both Atraumatic Restorative Treatment ART and the Hall Technique HT were created as part of Minimal Invasive Dentistry MID to slow the downward restorative spiral and reduce discomfort during the treatment as neither of which requires the administration of local anesthesia nor the use of rotary instruments
According to a retrospective analysis utilizing the Hall technique to seal cavities performed much better than using conventional restorations statistically and clinically during 10 years of follow-up
Since ART is associated with lower levels of anxiety pain and discomfort than traditional dentistry procedures it has become widely employed in pediatric dentistry Despite having reduced survival rates in multiple-surface restorations ART is still regarded as a viable evidence-based choice for treating and preventing caries lesions in primary posterior teeth since it is a quick inexpensive and comfortable procedure for the patient
Detailed Description:
One of the most prevalent childhood diseases dental caries affects up to 90 of children globally especially those from the underprivileged group
WHO estimates that Egypt has a 60 prevalence of dental caries Early childhood caries has a negative effect on a childs oral health-related quality of life Both the family and the child are directly affected
The ideal treatment of carious lesions has been the subject of recent revolutions Traditional restorative methods which focused on completely removing carious tooth tissue and then placing a restoration have been replaced by more biological and minimally invasive methods that concentrate on controlling biofilms and disrupting the cariogenic biofilm environment to stop caries
The Hall Technique HT supports this theory Without any dental preparation or caries removal a preformed metal crown PMC is simply fixed to the carious tooth using glass ionomer cement GIC The cariogenic biofilm beneath the cap is sealed
The Hall technique of stainless- steel crown placement has proved to be a viable restorative option for carious primary molars resulting in its successful exfoliation
Management techniques would include atraumatic restorative treatment as well as those in which dentine carious tissue is selectively removed to soft or firm dentine in a single session ART
ART has been widely used in pediatric dentistry because it is linked with lower levels of anxiety pain and discomfort as well as better acceptance by children compared to conventional treatment
ART uses only hand instruments to remove carious tissue and prepare the cavity Additional extended clinical investigations are required to assess the effectiveness of these methods in addressing carious lesions on diverse tooth surfaces and various dentin layers and to provide evidence supporting the integration of these techniques into standard practice
Since there is a need for further research with larger sample sizes and extended follow-up durations in Egypt to assess the effectiveness of these methods for treating carious primary teeth this study will be conducted
This research aims to compare the success of the Hall Technique to the Atraumatic Restorative treatment in the management of carious primary molars in children
WHO estimates that Egypt has a 60 prevalence of dental caries Early childhood caries has a negative effect on a childs oral health-related quality of life Both the family and the child are directly affected
The ideal treatment of carious lesions has been the subject of recent revolutions Traditional restorative methods which focused on completely removing carious tooth tissue and then placing a restoration have been replaced by more biological and minimally invasive methods that concentrate on controlling biofilms and disrupting the cariogenic biofilm environment to stop caries
The Hall Technique HT supports this theory Without any dental preparation or caries removal a preformed metal crown PMC is simply fixed to the carious tooth using glass ionomer cement GIC The cariogenic biofilm beneath the cap is sealed
The Hall technique of stainless- steel crown placement has proved to be a viable restorative option for carious primary molars resulting in its successful exfoliation
Management techniques would include atraumatic restorative treatment as well as those in which dentine carious tissue is selectively removed to soft or firm dentine in a single session ART
ART has been widely used in pediatric dentistry because it is linked with lower levels of anxiety pain and discomfort as well as better acceptance by children compared to conventional treatment
ART uses only hand instruments to remove carious tissue and prepare the cavity Additional extended clinical investigations are required to assess the effectiveness of these methods in addressing carious lesions on diverse tooth surfaces and various dentin layers and to provide evidence supporting the integration of these techniques into standard practice
Since there is a need for further research with larger sample sizes and extended follow-up durations in Egypt to assess the effectiveness of these methods for treating carious primary teeth this study will be conducted
This research aims to compare the success of the Hall Technique to the Atraumatic Restorative treatment in the management of carious primary molars in children
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