NCT07295574

Digital Occlusal Analysis and Bite Force Evaluation of the Hall Technique Vs Stainless Steel Crowns in Primary Molars Using T-scan

Digital Occlusal Analysis and Bite Force Evaluation of Hall Technique Vs Stainless-Steel Crowns as Conventional Restoration of Carious Primary Molars Using T-scan: A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled clinical trial aims to compare two restorative techniques for managing carious primary molars in children aged 6-9 years: the Hall Technique and conventional stainless-steel crown (SSC) placement. The study evaluates how each technique affects occlusal force distribution, mean bite force, and vertical dimension changes using the T-Scan digital occlusal analysis system. Additional outcomes include temporomandibular joint assessment, child discomfort levels, and parental satisfaction with treatment. Participants are allocated 1:1 to receive either the Hall Technique or conventional SSC restoration, and outcomes are measured at baseline, immediately after treatment, and at 2- and 4-week follow-ups. The study aims to determine whether the minimally invasive Hall Technique provides comparable occlusal function and patient-centered outcomes when compared to traditional SSC preparation methods.

Detailed description

This randomized controlled clinical trial evaluates the effect of two restorative techniques-the Hall Technique and conventional stainless-steel crown (SSC) placement-on digital occlusal parameters and bite force distribution in carious primary molars. The study uses T-Scan digital occlusal analysis to objectively measure changes in occlusion and vertical dimension following restoration. Children aged 6-9 years presenting with symptomless carious primary molars without pulpal involvement are eligible for inclusion. Participants are randomly assigned (1:1) to receive either an SSC placed using the Hall Technique (no caries removal or tooth preparation) or an SSC placed using the conventional technique (local anesthesia, caries removal, and tooth preparation). All clinical procedures are performed by a single operator to minimize performance bias, and the statistician is blinded during data analysis. Digital occlusal analysis is conducted using T-Scan Novus to measure bite force percentage and maximum intercuspal position at baseline, immediately after crown placement, and at follow-up visits (2 and 4 weeks). Changes in vertical dimension are evaluated using a digital caliper at the same intervals. Secondary assessments include temporomandibular signs and symptoms, child discomfort, and parental satisfaction using validated questionnaires. The primary objective is to compare mean biting force between the two restorative techniques over time. Secondary outcomes include changes in vertical dimension, presence of TMD-related symptoms, and subjective evaluations of comfort and esthetics. The study aims to provide clinical evidence regarding differences in occlusal equilibration and functional adaptation between biological minimally invasive management (Hall Technique) and the conventional restorative approach for carious primary molars. Results from this trial may help guide clinical decision-making regarding restorative methods that optimize occlusion, patient comfort, and treatment acceptance in pediatric dentistry.

Conditions

• Carious Primary Molars
• Bite Force
• Occlusal Analysis
• Stainless-steel Crown

Interventions

Type	Name	Description
PROCEDURE	Hall Technique Stainless Steel Crown Placement	Children allocated to the intervention group will receive stainless-steel crown (SSC) placement using the Hall technique, without local anesthesia, caries removal, or tooth preparation. An appropriately sized preformed stainless-steel crown (NuSmile®) will be selected based on mesiodistal width and crown fit, and cemented using glass ionomer luting cement. Orthodontic separators may be placed when required to facilitate crown seating. No occlusal adjustment will be performed. Digital occlusal analysis and bite force assessment will be conducted using the T-Scan system, and vertical dimension will be measured using a digital caliper preoperatively, immediately after crown placement, and during the follow-up period according to the study schedule.
PROCEDURE	Conventional Stainless Steel Crown Placement	Children allocated to the control group will receive conventional stainless-steel crown (SSC) restoration under local anesthesia following complete caries removal and standard tooth preparation, including occlusal reduction and proximal slicing. An appropriately sized preformed stainless-steel crown (NuSmile®) will be selected, adjusted if necessary, and cemented using glass ionomer luting cement. Occlusion will be clinically adjusted to eliminate premature contacts. Digital occlusal analysis and bite force assessment will be performed using the T-Scan system, and vertical dimension will be measured using a digital caliper preoperatively, immediately after crown placement, and during the follow-up period according to the study schedule.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-12-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: Egypt