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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Zirconia Crowns; Pulp-treated Primary Molars; Primary Teeth; Dental Occlusion

Treatments: Procedure: Pulp Therapy and Zirconia Crown Restoration of Primary Molars with T-Scan Occlusal Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07276841

PEDS-TSCAN-ZC-2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Zirconia Crown Restoration of Pulp-Treated Primary Molars

Experimental group

Description:

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.

Treatment:

Procedure: Pulp Therapy and Zirconia Crown Restoration of Primary Molars with T-Scan Occlusal Analysis