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

Official 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

Overview

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.

Interventions

• 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 an
• 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 an

Primary outcome measures

• Mean Bite Force [Time frame: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative]

Secondary outcome measures (5)

• Change in Vertical Dimension [Time frame: 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]
• Child Discomfort Level [Time frame: Immediate post-operative and 4 weeks post-operative]
• Parental Satisfaction with Esthetics [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Cairo University — Cairo

Publications

• Umapathy Thimmegowda and Radhakrishnan, A. (2023). Application of Tekscan in Pediatric Dentistry:AReview.pp.132-142. doi:Hall techniquetps://doi.org/10.9734/bpi/cidhr/v1/6603a
• Schuler IM, Hiller M, Roloff T, Kuhnisch J, Heinrich-Weltzien R. Clinical success of stainless steel crowns placed under general anaesthesia in primary molars: an observational follow up study. J Dent. 2014 Nov;42(11):1396-403. doi: 10.1016/j.jdent.2014.06.009. Epub 2014 Jun 30. PMID 24994618
• Herkar PP, Anantharaj A, Praveen P, Shankarappa PR, Sudhir R. A comparative study of conventional and Hall techniques of crown placement using finite element stress analysis. J Indian Soc Pedod Prev Dent. 2022 Jul-Sep;40(3):302-310. doi: 10.4103/jisppd.jisppd_173_22. PMID 36260472
• Rahate I, Fulzele P, Thosar N. Comparative evaluation of clinical performance, child and parental satisfaction of Bioflx, zirconia and stainless steel crowns in pediatric patients. F1000Res. 2023 Dec 21;12:756. doi: 10.12688/f1000research.133464.2. eCollection 2023. PMID 38911945
• Hu S, BaniHani A, Nevitt S, Maden M, Santamaria RM, Albadri S. Hall technique for primary teeth: A systematic review and meta-analysis. Jpn Dent Sci Rev. 2022 Nov;58:286-297. doi: 10.1016/j.jdsr.2022.09.003. Epub 2022 Sep 27. PMID 36185501
• Boyd DH, Thomson WM, Leon de la Barra S, Fuge KN, van den Heever R, Butler BM, Leov F, Foster Page LA. A Primary Care Randomized Controlled Trial of Hall and Conventional Restorative Techniques. JDR Clin Trans Res. 2021 Apr;6(2):205-212. doi: 10.1177/2380084420933154. Epub 2020 Jun 19. PMID 32559403
• Ayedun OS, Oredugba FA, Sote EO. Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars. Niger J Clin Pract. 2021 Apr;24(4):584-594. doi: 10.4103/njcp.njcp_460_20. PMID 33851682
• Araujo MP, Uribe S, Robertson MD, Mendes FM, Raggio DP, Innes NPT. The Hall Technique and exfoliation of primary teeth: a retrospective cohort study. Br Dent J. 2020 Feb;228(3):213-217. doi: 10.1038/s41415-020-1251-1. PMID 32060464

Identifiers

NCT: NCT07295574 · HT-SSC-TSCAN-RCT-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗