Endodontically Treated TeethB-FORCE RCTNCT07626372
Bite Force and Occlusal Force Distribution Following Root Canal Treatment.
An observational study of Endodontically Treated Teeth, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- 8 Jun 2026to 31 Oct 2030
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who underwent non-surgical root canal treatment at the Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn University
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn university
Bangkok, 10330
Uraiwan Chokechanachaisakul, 6622188795, uraiwan.c@chula.ac.th
Thanomsuk Jearanaiphaisarn, 6622188795, thanomsuk.j@chula.ac.th
About this study
Official title: Changes in Bite Force and Occlusal Force Distribution Following Root Canal Treatment, Restoration, and Over Time: A Prospective Observational Study
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.
- Conditions
- Endodontically Treated Teeth
- Keywords
- Bite force, occlusal force distribution, Endodontically treated teeth, Chewing side preference, Endodontic restoration, Prospective study
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
A questionnaire will be used to assess patients' subjective perceptions of chewing function, including preferred chewing side, frequency of hard food consumption, and parafunctional habits such as bruxism and clenching.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start8 Jun 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanomsuk Jearanaiphaisarn, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626372
- Sponsor's protocol ID
- HREC-DCU 2025-206
- Acronym
- B-FORCE RCT
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Bite Force and Occlusal Force Distribution Following Root Canal Treatment, Restoration, and Over Time: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07626372
- Acronym / sponsor ID
- B-FORCE RCT / HREC-DCU 2025-206
- Conditions
- Endodontically Treated Teeth
- Keywords
- Bite force, occlusal force distribution, Endodontically treated teeth, Chewing side preference, Endodontic restoration, Prospective study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who underwent non-surgical root canal treatment at the Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn University
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum bite force
Time frame: 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.
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.
Relative occlusal force
Time frame: 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 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.
1 secondary outcome
Patients' subjective perception of chewing function
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endodontically Treated Teeth, run by Chulalongkorn University at 1 site in Thailand.
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 4 inclusion and 5 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 4 Jun 2026. 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 Thailand. 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 Thanomsuk Jearanaiphaisarn (6622188795, thanomsuk.j@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum bite force (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.