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Clinical Trials/NCT07276841
NCT07276841
Not yet recruiting
Not Applicable

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

Cairo University1 site in 1 country11 target enrollmentStarted: January 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
11
Locations
1
Primary Endpoint
Mean Bite Force

Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 9 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Vertical Dimension(Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative)
  • Parental Rating of Esthetic Satisfaction(immediate post-operative and 4 weeks post-operative)
  • Parental Rating of Treatment Impact on Child(immediate post-operative and 4 weeks post-operative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lama Hatem Mohamed Kamal Belal

Master's Student, Department of Pediatric Dentistry

Cairo University

Study Sites (1)

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