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NCT Number: NCT07295574

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

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.

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Key information

Conditions

Carious Primary Molars Bite Force Occlusal Analysis Stainless-steel Crown

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hall Technique Stainless Steel Crown Placement

Procedure

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.

Conventional Stainless Steel Crown Placement

Procedure

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.

Primary outcomes

  1. 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 %.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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).

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lujain Y Wagih Youssef, B.D.S Faculty of Dentistry

CONTACT

[email protected]

+201097906344

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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