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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Carious Primary Molars; Occlusal Analysis; Bite Force; Stainless-steel Crown

Treatments: Procedure: Conventional Stainless Steel Crown Placement; Procedure: Hall Technique Stainless Steel Crown Placement

Study type: Interventional

Funder types: Other

Identifiers

NCT07295574

HT-SSC-TSCAN-RCT-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Systemically healthy children
2. Age ranging from 6 to 9 years
3. Cooperative behavior (positive rating on the Frankl Behavior Rating Scale)
4. Unrestored carious primary molar
5. Extent of caries radiographically confined to dentin (≤ or > ½ dentin thickness)
6. Tooth must be vital and symptomless, with no clinical or radiographic signs of pulpal pathology

Exclusion criteria

1. Children with special health care needs
2. Temporomandibular disorders, bruxism or parafunctional habits
3. pathological facial swelling
4. periodontal diseases such as gingivitis, drug-induced gingival enlargement, juvenile or aggressive periodontitis
5. Any child showing mobility, bone loss, or signs of pulpal pathology is also excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Hall Technique Stainless-Steel Crown Placement

Experimental group

Description:

Participants in this arm will receive a stainless-steel crown (NuSmile) placed using the Hall Technique, a minimally invasive method that does not require local anesthesia, caries removal, or tooth preparation. The appropriately sized crown will be selected based on mesiodistal measurements and trial fitting, then cemented using glass ionomer luting cement. Orthodontic separators may be placed when contacts are tight. Outcome measurements (T-Scan bite force, vertical dimension, questionnaires) will be taken at baseline, immediately after placement, and at 2- and 4-week follow-ups.

Treatment:

Procedure: Hall Technique Stainless Steel Crown Placement

Conventional Stainless-Steel Crown Restoration

Active Comparator group

Description:

Participants in this arm will receive a stainless-steel crown (NuSmile) placed using the traditional conventional technique. This includes local anesthesia, complete caries removal, and tooth preparation (occlusal reduction \~1.5 mm, proximal slicing). The crown will be fitted, adjusted for proper occlusion, and cemented using glass ionomer luting cement. Standardized outcome measurements (T-Scan bite force, vertical dimension, questionnaires) will be recorded at baseline, immediately post-operatively, and at 2- and 4-week follow-ups.

Treatment:

Procedure: Conventional Stainless Steel Crown Placement