NCT07626372

Brief Summary

Understanding the changes in bite force and occlusal force distribution in ETT is clinically important, as it can directly influence tooth prognosis, guide restorative treatment planning, and impact the long-term survival of the treated tooth. Therefore, this study aims to further explore changes and possible correlation in maximum bite force (MBF), occlusal force distribution and patients' subjective perception of chewing function of endodontically treated teeth after non-surgical root canal treatment, subsequent restoration, and during long-term follow-up, along with comparing to contralateral vital teeth. Methods: Patients aged 20-60 years who underwent non-surgical root canal treatment at the Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn University, with the following teeth indicated for endodontic treatment. Measurements of maximum bite force (MBF) of ETT and contralateral vital teeth, relative occlusal force (ROF), and questionnaire responses, are performed at the following time points: before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT. Differences in MBF and ROF over time points within subjects and differences in MBF and ROF between ETT and their contralateral vital teeth were statistically analyzed.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
52mo left

Started Jun 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Oct 2030

First Submitted

Initial submission to the registry

May 31, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 8, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2030

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 31, 2026

Last Update Submit

May 31, 2026

Conditions

Keywords

Bite forceocclusal force distributionEndodontically treated teethChewing side preferenceEndodontic restorationProspective study

Outcome Measures

Primary Outcomes (2)

  • Maximum bite force

    Maximum bite force of the endodontically treated tooth and its contralateral tooth in each patient will be measured using the FlexiForce ELF System and FlexiForce B201 sensor.

    before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.

  • Relative occlusal force

    Relative Occlusal Force are measured with the T-Scan III system. A device will be inserted into the mouth of the patients, and they are instructed to bite firmly three times at the maximum cusp intersection position.

    before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.

Secondary Outcomes (1)

  • Patients' subjective perception of chewing function

    before NS-RCT, 1 month after completion of NS-RCT (before doing restoration), 3 months after crown restoration, 1, 2 and 4 years after completion of NS-RCT.

Study Arms (1)

Endodontic patient

Patients aged 20-60 years undergoing non-surgical root canal treatment and subsequent restoration at the Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn University, with prospective assessment of bite force and occlusal force distribution over time.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent non-surgical root canal treatment at the Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn University

You may qualify if:

  • Premolars or molars diagnosed with pulp necrosis or previously initiate therapy with normal apical tissues, asymptomatic apical periodontitis, or chronic apical abscess without full coverage restoration.
  • Adequate remaining tooth structure for cuspal coverage restoration.
  • Presence of adjacent teeth and functional opposing natural teeth.
  • No analgesics drug effect at the time of investigation or not have taken analgesics 6 hours ago.

You may not qualify if:

  • Patients undergoing other dental treatments during the study period that may interfere with occlusion or bite force distribution, such as orthodontic treatment, jaw surgery, or full mouth restoration.
  • Received treatments that cause weakness of the jaw and facial muscles, such as botox injections.
  • History or symptoms of temporomandibular disorders (TMD)
  • Periodontal disease with second- or third-degree mobility
  • Teeth presenting crack lines extending into the pulp chamber floor or root canal orifices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn university

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Central Study Contacts

Thanomsuk Jearanaiphaisarn

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Operative Dentistry

Study Record Dates

First Submitted

May 31, 2026

First Posted

June 4, 2026

Study Start

June 8, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2030

Last Updated

June 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations