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

NCT07295574 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-12-19

No results posted yet for this study

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

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

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 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.

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Osama A El Shahawy, PhD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Egypt

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07295574 on ClinicalTrials.gov