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

NCT07276841 | Not Yet Recruiting

• 1 other identifier: PEDS-TSCAN-ZC-2025-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Occlusion; Bite Force; Pediatric Dentistry; Zirconia Crown; T-Scan; Primary Teeth; Restorative Dentistry

Outcome Measures

Primary Outcomes (1)

• Mean Bite Force

  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 Outcomes (3)

• 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

Study Arms (1)

Zirconia Crown Restoration of Pulp-Treated Primary Molars

EXPERIMENTAL

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

Interventions

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

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.

Zirconia Crown Restoration of Pulp-Treated Primary Molars

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

Related Publications (10)

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Maheshkumar K, Chowdhary N, Chowdharry R, Vundela RR, Sonnahalli NK, Anuraaga AT. Bite force evaluation at maximal intercuspal position: An in vivo comparative study between stainless steel and zirconia crowns on primary molar teeth. J Indian Soc Pedod Prev Dent. 2023 Apr-Jun;41(2):89-97. doi: 10.4103/jisppd.jisppd_156_23.

  PMID: 37635466 RESULT

• Bozhkova TP. The T-SCAN System in Evaluating Occlusal Contacts. Folia Med (Plovdiv). 2016 Apr-Jun;58(2):122-30. doi: 10.1515/folmed-2016-0015.

  PMID: 27552789 RESULT

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

Lama Hatem Mohamed Kamal Belal, B.D.S Faculty of Dentistry

CONTACT

+201010471384; lama.hatem@dentistry.cu.edu.eg

Prof.Dr.Osama El Shahawy Chief Supervisor, PhD

CONTACT

+201005634755; osama.shahawy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student, Department of Pediatric Dentistry

Model Details: This is a single-group, before-and-after interventional study. All participants will receive the intervention, which is restoration of pulp-treated primary molars with prefabricated zirconia crowns. Outcome measures, including bite force and occlusal adaptation, will be recorded prior to crown placement (baseline) and at follow-up visits 2 weeks and 4 weeks post-restoration to assess functional adaptation over time.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)