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

Official title

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

Overview

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.

Interventions

• 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-

Primary outcome measures

• Mean Bite Force [Time frame: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative]

Secondary outcome measures (3)

• Vertical Dimension [Time frame: 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]
• Parental Rating of Treatment Impact on Child [Time frame: immediate post-operative and 4 weeks post-operative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry, Cairo University — Cairo

Publications

• Umapathy Thimmegowda and Radhakrishnan, A. (2023). Application of Tekscan in Pediatric Dentistry: A Review. Researchgate, pp.132-142. doi:https://doi.org/10.9734/bpi/cidhr/v1/6603a.
• Nair K, Chikkanarasaiah N, Poovani S, Thumati P. Digital occlusal analysis of vertical dimension and maximum intercuspal position after placement of stainless steel crown using hall technique in children. Int J Paediatr Dent. 2020 Nov;30(6):805-815. doi: 10.1111/ipd.12647. Epub 2020 May 7. PMID 32248585
• Panwar, M., Gupta, S., Singh, U., Das, A., & Isha, S. (2023). Role of Intraoral Scanners in Pediatric Dentistry. International Journal of Medical and Dental Sciences, 2071-2076. https://doi.org/10.18311/ijmds/2023/646
• Rahate I, Fulzele P, Thosar N. Comparative evaluation of clinical performance, child and parental satisfaction of Bioflx, zirconia and stainless steel crowns in pediatric patients. F1000Res. 2023 Dec 21;12:756. doi: 10.12688/f1000research.133464.2. eCollection 2023. PMID 38911945
• Haghgoo R, Abbasi F. Clinical and Radiographic Success of Pulpotomy with MTA in Primary Molars: 30 Months Follow up. Iran Endod J. 2010 Fall;5(4):157-60. Epub 2010 Nov 15. PMID 23130045
• Sowmya Gujjar Vishnurao, Madhusudan Astekar and Aggarwal, A. (2023). T scan - A review on an occlusal indicator in dentistry. International Journal of Maxillofacial Imaging, 9(3), pp.119-124. doi:https://doi.org/10.18231/j.ijmi.2023.021
• Abutayyem H, M Annamma L, Desai VB, Alam MK. Evaluation of occlusal bite force distribution by T-Scan in orthodontic patients with different occlusal characteristics: a cross sectional-observational study. BMC Oral Health. 2023 Nov 20;23(1):888. doi: 10.1186/s12903-023-03544-4. PMID 37986159
• Alzanbaqi SD, Alogaiel RM, Alasmari MA, Al Essa AM, Khogeer LN, Alanazi BS, Hawsah ES, Shaikh AM, Ibrahim MS. Zirconia Crowns for Primary Teeth: A Systematic Review and Meta-Analyses. Int J Environ Res Public Health. 2022 Feb 28;19(5):2838. doi: 10.3390/ijerph19052838. PMID 35270531

Identifiers

NCT: NCT07276841 · PEDS-TSCAN-ZC-2025-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗