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

December 16, 2025 updated by: Lujain Yasser Wagih Youssef, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Giza Governorate
      • Cairo, Giza Governorate, Egypt, 12613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hall Technique Stainless-Steel Crown Placement
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.
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.
Active Comparator: Conventional Stainless-Steel Crown Restoration
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Bite Force
Time Frame: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative
Occlusal evaluation for bite force will be done using T-Scan III. Changes in bite force at different periods will be assessed using a standardized T-Scan III Software. The obtained bite force will be recorded in percentage concerning the crowned tooth, opposing tooth, right and left side of the arch, during preoperative, postoperative and follow up periods after 2 and 4 weeks. The maximum intercuspal position (MIP) will be measured by changes in the bite force %.
Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vertical Dimension
Time Frame: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative
The vertical dimension will be assessed to evaluate any changes in occlusal height following crown placement using either the Hall technique or the conventional stainless steel crown technique. Measurements will be taken using a digital caliper at four time points: preoperatively, immediately after crown placement, at 2 weeks, and at 4 weeks postoperatively. The vertical distance of the overbite will be measured in millimeters between the maxillary and mandibular canines while the child is in maximum intercuspal position. This outcome is used to detect temporary occlusal discrepancies and to monitor the process of occlusal re-equilibration over time following crown placement.
Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative
Temporomandibular Joint (TMJ) Assessment
Time Frame: Baseline (pre-operative) and 4 weeks post-operative
Temporomandibular joint status will be evaluated using a standardized questionnaire based on the American Academy of Pediatric Dentistry (AAPD) guidelines. The assessment consists of binary (yes/no) questions addressing symptoms such as pain during chewing, jaw clicking, difficulty in mouth opening, jaw locking, or discomfort around the ears and cheeks. This outcome is measured to detect any functional disturbance associated with changes in occlusion after stainless steel crown placement by either technique.
Baseline (pre-operative) and 4 weeks post-operative
Child Discomfort Level
Time Frame: Immediate post-operative and 4 weeks post-operative
The level of discomfort experienced by the child after crown placement will be assessed using the Wong-Baker FACES Pain Rating Scale. This validated tool allows children to express their perceived pain using facial expressions representing increasing levels of discomfort, ranging from 0 (no pain, smiling face) to 10 (worst pain, crying face), with intermediate scores of 2, 4, 6, and 8 corresponding to increasing pain intensity. This outcome helps compare patient tolerance and comfort between the minimally invasive Hall technique and the conventional stainless ste
Immediate post-operative and 4 weeks post-operative
Parental Satisfaction with Esthetics
Time Frame: Immediate post-operative and 4 weeks post-operative
Parental satisfaction with the esthetic appearance of the crown will be assessed using a structured questionnaire based on a five-point Likert scale. Parents will be asked to rate the size, shape, color, and overall appearance of the crown, with responses ranging from 1 (very dissatisfied), 2 (dissatisfied), 3 (neutral), 4 (satisfied), to 5 (very satisfied).
Immediate post-operative and 4 weeks post-operative
Parental Perception of Treatment Impact on the Child
Time Frame: Immediate post-operative and 4 weeks post-operative
Parents will evaluate the overall impact of the treatment on their child using a structured questionnaire with a five-point Likert scale, with responses ranging from 1 (not at all satisfied) to 5 (very much satisfied). The questionnaire will assess the following aspects: improvement in the child's oral health after crown placement, parents' concern about the appearance of the teeth before crowns, whether the child avoided smiling before crowns, whether the child smiled after crowns, and whether the crowns improved the overall appearance of the child's teeth. This outcome helps assess the psychosocial and functional impact of both the Hall technique and the conventional stainless steel crown technique from the caregiver's perspective.
Immediate post-operative and 4 weeks post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Osama A El shahawy, PHD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HT-SSC-TSCAN-RCT-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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