A Randomized Clinical Trial Comparing Hall vs. Conventional Technique in Primary Molars.

Dental Caries Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 child's 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.

Methods/Design:

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), children's 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 children's pain perception and cooperation in dental setting and parents' acceptability as well. ;

Related Conditions & MeSH terms

• Dental Caries

• NCT number: NCT06350578
• Study type: Interventional
• Source: Primary Health Care Corporation, Qatar
• Contact: Hanan A Mohamed
• Phone: +97450132314
• Email: hananmohamed@phcc.gov.qa
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Completion date: June 2025