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Dental OcclusionNCT07276841

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

A study testing Pulp Therapy and Zirconia Crown Restoration of Primary Molars with T-Scan Occlusal Analysis in people with Dental Occlusion and Primary Teeth, run by Cairo University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 9 years
What is being tested?
Pulp Therapy and Zirconia Crown Restoration of Primary Molars with T-Scan Occlusal Analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteEgypt
Study dates
Jan 2026to Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Egypt1 site
  • Faculty of Dentistry, Cairo University

    Cairo, Giza Governorate, 12613

    Lama Hatem Mohamed Kamal Belal, BDS, +201010471384, lama.hatem@dentistry.cu.edu.eg

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
Pulp Therapy and Zirconia Crown Restoration of Primary Molars with T-Scan Occlusal Analysis
Keywords
Occlusion, Bite Force, Pediatric Dentistry, Zirconia Crown, T-Scan, Primary Teeth, Restorative Dentistry
Medical subject headings
Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulp Therapy and Zirconia Crown Restoration of Primary Molars with T-Scan Occlusal AnalysisProcedure or surgery

    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.

Study groups in NCT07276841
Study groupRoleWhat they receive
Zirconia Crown Restoration of Pulp-Treated Primary MolarsExperimentalAll 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.
Receives: Procedure: Pulp Therapy and Zirconia Crown Restoration of Primary Molars with T-Scan Occlusal Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative

Secondary outcomes (3)
  1. Vertical Dimension

    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.

    Measured: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative

  2. Parental Rating of Esthetic Satisfaction

    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

    Measured: immediate post-operative and 4 weeks post-operative

  3. Parental Rating of Treatment Impact on Child

    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

    Measured: immediate post-operative and 4 weeks post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study startJan 2026 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
11 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07276841
Sponsor's protocol ID
PEDS-TSCAN-ZC-2025-01
Status last verified
Nov 2025
First submitted
30 Nov 2025
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35270531
  • 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.

    PubMed 37635466
  • 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.

    PubMed 27552789

Questions about this trial

What is this clinical trial studying?

A study testing Pulp Therapy and Zirconia Crown Restoration of Primary Molars with T-Scan Occlusal Analysis in people with Dental Occlusion and Primary Teeth, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lama Hatem Mohamed Kamal Belal, B.D.S Faculty of Dentistry (+201010471384, lama.hatem@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Bite Force (time frame: Baseline (pre-operative), immediate post-operative, 2 weeks post-operative, 4 weeks post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07276841, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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