Digital Occlusal Analysis and Bite Force Evaluation of Primary Molars Restored With Zirconia Crowns Using T-Scan

November 30, 2025 updated by: Lama Hatem Mohamed Kamal Belal, Cairo University

Digital Occlusal Analysis and Bite Force Evaluation of Pulp Treated Primary Molars Restored With Zirconia Crowns Using T-Scan: An Experimental Before-and-After Study

The goal of this observational study is to evaluate the adaptation of occlusion and bite force after zirconia crown restoration in children with pulp-treated primary molars. The main questions it aims to answer are:

How does occlusion adapt after placement of zirconia crowns?

Does bite force change following crown restoration?

Participants will:

Undergo routine pulp treatment and restoration of primary molars with zirconia crowns.

Have bite force and occlusal contacts measured using the T-Scan digital occlusal analysis system before and after crown placement.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

his observational before-and-after study is designed to evaluate occlusal adaptation and functional outcomes in children undergoing pulp treatment and restoration of primary molars with zirconia crowns. The study employs the T-Scan Novus digital occlusal analysis system to objectively measure bite force distribution and occlusal contact patterns.

After informed consent is obtained from parents or legal guardians, baseline occlusal measurements will be collected using the T-Scan system prior to crown placement. Standard pulp therapy and restoration procedures will be performed according to pediatric dental protocols. Prefabricated zirconia crowns will be selected and fitted, with occlusal adjustments performed as needed to ensure proper seating and contact.

Participants will be scheduled for follow-up visits at 2 weeks and 4 weeks post-restoration, during which occlusal measurements will be repeated using the T-Scan system. These follow-ups are designed to track the progressive adaptation of occlusion and detect any functional changes following crown placement.

Additional technical considerations include:

Calibration of the T-Scan system prior to each measurement session.

Standardized patient positioning during measurements to ensure reproducibility.

Recording of bite force in a controlled environment, minimizing variables such as head posture and tongue position.

Monitoring of crown integrity and fit during follow-up visits.

This study will provide detailed insight into the functional adaptation of primary molars after zirconia crown restoration, including occlusal contact patterns and bite force distribution, contributing to evidence-based recommendations for pediatric restorative dentistry.

Study Type

Interventional

Enrollment (Estimated)

11

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 Contact Backup

Study Locations

  • Egypt
    • Giza Governorate
      • Cairo, Giza Governorate, Egypt, 12613
        • Faculty of Dentistry, Cairo University
        • Contact:

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:

  • Children aged 6 to 9 years.
  • Both boys and girls can participate.
  • A pulp-treated primary molar (pulpotomy) that is healthy and shows no pain, no swelling, no mobility, and no radiographic problems (such as internal resorption or infection).
  • The lower first permanent molar must be erupted.
  • The child is cooperative during dental treatment (positive behavior on the Frankl scale).
  • The child has no missing teeth.
  • The child has a normal bite (normal overjet and overbite).
  • The child is generally healthy with no systemic diseases, to ensure they can attend follow-ups.

Exclusion Criteria:

  • Children with medical conditions or who are uncooperative during dental care.
  • Children with parafunctional habits, such as teeth grinding (bruxism), thumb-sucking, or other habits that may affect bite-force measurements.
  • Teeth that are close to falling out, have severe root resorption, or need extraction.
  • Teeth with deep cavities below the gum line that prevent proper crown placement.
  • Teeth that are mobile (Miller's Grade 2 or higher).
  • Teeth that have had previous pulp therapy other than the included pulpotomy.
  • Children who are unable to attend follow-up visits or whose parents do not agree to participate.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zirconia Crown Restoration of Pulp-Treated Primary Molars
All participants will receive pulp therapy and restoration of primary molars with prefabricated zirconia crowns. Bite force and occlusal contacts will be measured using the T-Scan digital occlusal analysis system at baseline, 2 weeks, and 4 weeks post-restoration. Participants act as their own control, with pre-restoration measurements compared to post-restoration outcomes. No comparison or additional study arms are included.
Procedure: Pulp Therapy and Zirconia Crown Restoration of Primary Molars with T-Scan Occlusal Analysis
Participants will receive pulp therapy followed by restoration of primary molars with prefabricated zirconia crowns according to standard pediatric dental protocols. Occlusal function and bite force will be assessed using the T-Scan digital occlusal analysis system at baseline, and at 2 and 4 weeks post-restoration. This intervention combines a therapeutic dental procedure with objective, instrumented measurement of occlusal adaptation, allowing participants to act as their own controls. Follow-up visits will monitor crown fit, occlusal contacts, and bite force changes over time.

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
Bite force will be measured using the T-Scan digital occlusal analysis system. Participants will bite on the sensor in a standardized position, and the system will record bite force as a percentage of total occlusal force distributed among teeth. This measure reflects functional adaptation of occlusion after crown placement.
Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical Dimension
Time Frame: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative
Vertical dimension will be measured using a digital vernier caliper. Before local anesthesia, the vertical distance (overbite) at the cuspid will be measured, with the child seated upright in maximum intercuspal position. The most prominent incisal edge of the maxillary cuspid will be marked, and the vertical distance to the mandibular cuspid measured. Measurements will be recorded at pre-operative, immediate post-operative, and 1, 2, and 4 weeks post-operative to assess changes in occlusion following operative zirconia crown placement.
Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative
Parental Rating of Esthetic Satisfaction
Time Frame: immediate post-operative and 4 weeks post-operative
Description: Parents will rate the appearance of the treated teeth using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). This measure assesses parental satisfaction with the esthetics of the operative zirconia crown placement at each follow-up
immediate post-operative and 4 weeks post-operative
Parental Rating of Treatment Impact on Child
Time Frame: immediate post-operative and 4 weeks post-operative

Parents will complete a structured questionnaire assessing the perceived impact of zirconia crown placement on their child's oral health, appearance, and psychosocial comfort. The questionnaire consists of 5 items, each scored on a 5-point Likert scale, where:

1 = Not at all satisfied

5 = Very much satisfied

Items include:

Oral health of the child improved after crowns

Parents' concern about appearance before the crowns

Child avoided smiling before the crowns

Child smiled after crowns

Crowns improved the appearance of the child's teeth

Higher scores indicate greater positive impact of the treatment on the child's oral health and well-being
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

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

November 30, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEDS-TSCAN-ZC-2025-01

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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