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

NCT07295574 | Not Yet Recruiting

• 1 other identifier: HT-SSC-TSCAN-RCT-2025
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Hall Technique; Stainless Steel Crown; Carious Primary Molars; Digital Occlusal Analysis; T-Scan; Bite Force; Occlusal Force Distribution; Vertical Dimension; Pediatric Dentistry; Minimal Intervention Dentistry; Conventional Crown Preparation; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Mean Bite Force

  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 Outcomes (5)

• Change in Vertical Dimension

  Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative

• Temporomandibular Joint (TMJ) Assessment

  Baseline (pre-operative) and 4 weeks post-operative

• Child Discomfort Level

  Immediate post-operative and 4 weeks post-operative

• Parental Satisfaction with Esthetics

  Immediate post-operative and 4 weeks post-operative

• Parental Perception of Treatment Impact on the Child

  Immediate post-operative and 4 weeks post-operative

Study Arms (2)

Hall Technique Stainless-Steel Crown Placement

EXPERIMENTAL

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

Conventional Stainless-Steel Crown Restoration

ACTIVE COMPARATOR

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

Interventions

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.

Conventional Stainless-Steel Crown Restoration

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.

Hall Technique Stainless-Steel Crown Placement

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

Related Publications (13)

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Amlani DV, Brizuela M. Stainless Steel Crowns in Primary Dentition. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK574547/

  PMID: 34662061 BACKGROUND

• Nair K, Chikkanarasaiah N, Poovani S, Thumati P. Digital occlusal analysis of vertical dimension and maximum intercuspal position after placement of stainless steel crown using hall technique in children. Int J Paediatr Dent. 2020 Nov;30(6):805-815. doi: 10.1111/ipd.12647. Epub 2020 May 7.

  PMID: 32248585 RESULT

• Maheshkumar K, Chowdhary N, Chowdharry R, Vundela RR, Sonnahalli NK, Anuraaga AT. Bite force evaluation at maximal intercuspal position: An in vivo comparative study between stainless steel and zirconia crowns on primary molar teeth. J Indian Soc Pedod Prev Dent. 2023 Apr-Jun;41(2):89-97. doi: 10.4103/jisppd.jisppd_156_23.

  PMID: 37635466 RESULT

• Bhatia HP, Khari PM, Sood S, Sharma N, Singh A. Evaluation of Clinical Effectiveness and Patient Acceptance of Hall Technique for Managing Carious Primary Molars: An In Vivo Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):548-552. doi: 10.5005/jp-journals-10005-1699.

  PMID: 32440073 RESULT

• Aishwarya N, Nagarathna C, Poovani S, Thumati P. Comparison of Bite Force and the Influencing Factors Pre- and Post-cementation of Stainless Steel Crown in Children Using T-Scan. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):46-50. doi: 10.5005/jp-journals-10005-1900.

  PMID: 34326583 RESULT

Study Officials

• Osama A El Shahawy, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+201097906344; lujain.yasser@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student, Department of Pediatric Dentistry

Model Details: This study is designed as a prospective, parallel group, randomized controlled clinical trial with a 1:1 allocation ratio, comparing two restorative techniques for carious primary molars: the Hall Technique (intervention) and the conventional stainless-steel crown (control).

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)