- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Thanomsuk Jearanaiphaisarn
- Numero di telefono: 6622188795
- Email: thanomsuk.j@chula.ac.th
Luoghi di studio
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Bangkok, Tailandia, 10330
- Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn university
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Contatto:
- Thanomsuk Jearanaiphaisarn
- Numero di telefono: 6622188795
- Email: thanomsuk.j@chula.ac.th
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Contatto:
- Uraiwan Chokechanachaisakul
- Numero di telefono: 6622188795
- Email: uraiwan.c@chula.ac.th
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Investigatore principale:
- Prom Wongmaneerojn
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Maximum bite force
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Patients' subjective perception of chewing function
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HREC-DCU 2025-206
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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