Clinical trial NCT06592885: Comparing Minimally Invasive Techniques Used in Treatment of Carious Primary Molars in Children
Official title: Evaluation of Success of Hall Technique Versus Atraumatic Restorative Treatment in the Management of Carious Primary Molars: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Dentistry
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 68
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and/or 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.

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 child's 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.

Eligibility criteria: Inclusion Criteria:

1. Age: From 4 to 6 years.
2. Caries in primary molars within enamel/dentin with vital pulp.
3. Healthy children.
4. Cooperative children.

Exclusion Criteria:

1. Presence of signs and symptoms of necrosis.
2. Root caries.
3. History of Spontaneous pain.

Primary outcomes:
measure: Clinical Success, Assessed by clinical examination
timeFrame: From enrollment to the end of treatment at 12 months (with follow up at 3-6-9-12 months)
Secondary outcomes:
measure: Post-operative pain and discomfort
timeFrame: Measured immediately after placement of SSC or restoration
measure: Child Behavior
timeFrame: Measured immediately after placement of SSC or restoration
measure: Child Anxiety
timeFrame: Measured immediately after placement of SSC or restoration
measure: Canine overbite: HT
timeFrame: Measured in millimeters immediately after placement of pre-fabricated stainless steel crown (SSC)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.
Study officials:
affiliation: Cairo University
name: Gihan Abou Elneil Professor of Pediatric Dentistry and Dental Public Health, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ahmed El. Khadem Associate Professor of Pediatric Dentistry, Associate Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Dr. Shereen Hassan El-Shamy Lecturer of Pediatric Dentistry
role: STUDY_DIRECTOR
References:
citation: Kaptan A, Korkmaz E. Evaluation of success of stainless steel crowns placed using the hall technique in children with high caries risk: A randomized clinical trial. Niger J Clin Pract. 2021 Mar;24(3):425-434. doi: 10.4103/njcp.njcp_112_20.