Comparing Minimally Invasive Techniques Used in Treatment of Carious Primary Molars in Children

NCT ID: NCT06592885

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-11-01

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.

Conditions

Pediatric Dentistry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hall Technique in treatment of carious primary molars

The Hall technique, proposed by Norna Hall in the 1980s, involves the placement of preformed metal crowns on primary molars without any tooth preparation or local anesthesia

Group Type: ACTIVE_COMPARATOR

Hall Technique in treatment of carious primary molars

Intervention Type: PROCEDURE

The Hall technique, proposed by Norna Hall in the 1980s, involves the placement of preformed metal crowns on primary molars without any tooth preparation or local anesthesia.

Advocates of the Hall technique emphasize its simplicity, reduced need for traditional drilling, and high reported success rates in clinical studies.

However, concerns have been raised regarding long-term aesthetics and potential psychological impacts due to the visibility of metal crowns.

Atraumatic Restorative Treatment in treatment of carious primary molars

ART, which took place in Tanzania during the mid-1980s, is a conservative approach involving the removal of carious lesions using hand instruments, followed by the application of a glass ionomer restoration, promoting the preservation of tooth structure.

Group Type: EXPERIMENTAL

Atraumatic Restorative Treatment in treatment of carious primary molars

Intervention Type: PROCEDURE

ART, which took place in Tanzania during the mid-1980s, is a conservative approach involving the removal of carious lesions using hand instruments, followed by the application of a glass ionomer restoration. This technique aims to be minimally invasive, promoting the preservation of tooth structure. The ART technique, employed in situations where ideal clinical conditions are challenging to achieve, has demonstrated effectiveness as a reliable method for managing cases where conventional treatment methods face resistance from children . However, concerns exist regarding the longevity of ART restorations and the impact of operator skill on outcomes.

Interventions

Atraumatic Restorative Treatment in treatment of carious primary molars

ART, which took place in Tanzania during the mid-1980s, is a conservative approach involving the removal of carious lesions using hand instruments, followed by the application of a glass ionomer restoration. This technique aims to be minimally invasive, promoting the preservation of tooth structure. The ART technique, employed in situations where ideal clinical conditions are challenging to achieve, has demonstrated effectiveness as a reliable method for managing cases where conventional treatment methods face resistance from children . However, concerns exist regarding the longevity of ART restorations and the impact of operator skill on outcomes.

Intervention Type: PROCEDURE

Hall Technique in treatment of carious primary molars

The Hall technique, proposed by Norna Hall in the 1980s, involves the placement of preformed metal crowns on primary molars without any tooth preparation or local anesthesia.

Advocates of the Hall technique emphasize its simplicity, reduced need for traditional drilling, and high reported success rates in clinical studies.

However, concerns have been raised regarding long-term aesthetics and potential psychological impacts due to the visibility of metal crowns.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Atef Ahmed

Principal invistigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gihan Abou Elneil Professor of Pediatric Dentistry and Dental Public Health, Professor

Role: STUDY_DIRECTOR

Cairo University

Ahmed El. Khadem Associate Professor of Pediatric Dentistry, Associate Professor

Role: STUDY_DIRECTOR

Cairo University

Dr. Shereen Hassan El-Shamy Lecturer of Pediatric Dentistry

Role: STUDY_DIRECTOR

Cairo University

Locations

Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.

Cairo, , Egypt

Countries

Egypt

Central Contacts

Mariam Atef Ahmed Dentist, B.D.S., Faculty of Dentistry

Role: CONTACT

mariam.wahid@dentistry.cu.edu.eg

1111199543 ext. +20

Facility Contacts

Faculty of Dentistry Cairo University Faculty of Dentistry Cairo University

Role: primary

dentmail@dentistry.cu.edu.eg

(+202) 23634965

References

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.

Reference Type: BACKGROUND

PMID: 33723119 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/33723119/

Related Info

Other Identifiers

HT Vs ART in pedodontics

Identifier Type: -

Identifier Source: org_study_id