Faculty of Dentistry, Cairo University
Cairo, Giza Governorate, 12613, Egypt
NCT Number: NCT07276841
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.
Trial opening soon.
Get Notified6 year–9 year
All sexes
Interventional
Not applicable
Cairo, Giza Governorate, 12613, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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
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
Contact information is provided by the study sponsor or research team.
Lama Hatem Mohamed Kamal Belal, B.D.S Faculty of Dentistry
CONTACT
Prof.Dr.Osama El Shahawy Chief Supervisor, PhD
CONTACT
Cairo University
Other
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
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