- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07626372
Bite Force and Occlusal Force Distribution Following Root Canal Treatment. (B-FORCE RCT)
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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Thanomsuk Jearanaiphaisarn
- 전화번호: 6622188795
- 이메일: thanomsuk.j@chula.ac.th
연구 장소
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Bangkok, 태국, 10330
- Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn university
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연락하다:
- Thanomsuk Jearanaiphaisarn
- 전화번호: 6622188795
- 이메일: thanomsuk.j@chula.ac.th
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연락하다:
- Uraiwan Chokechanachaisakul
- 전화번호: 6622188795
- 이메일: uraiwan.c@chula.ac.th
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수석 연구원:
- Prom Wongmaneerojn
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum bite force
기간: 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.
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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.
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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.
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Relative occlusal force
기간: 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.
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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.
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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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patients' subjective perception of chewing function
기간: 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.
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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.
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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.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HREC-DCU 2025-206
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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