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Bite Force and Occlusal Force Distribution Following Root Canal Treatment. (B-FORCE RCT)

31. mai 2026 oppdatert av: Thanomsuk Jearanaiphaisarn, Chulalongkorn University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Observasjonsmessig

Registrering (Antatt)

70

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Bangkok, Thailand, 10330
        • Graduate Endodontic Clinic, Faculty of Dentistry, Chulalongkorn university
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Prom Wongmaneerojn

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum bite force
Tidsramme: 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.
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
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patients' subjective perception of chewing function
Tidsramme: 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.
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.
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

8. juni 2026

Primær fullføring (Antatt)

31. oktober 2027

Studiet fullført (Antatt)

31. oktober 2030

Datoer for studieregistrering

Først innsendt

31. mai 2026

Først innsendt som oppfylte QC-kriteriene

31. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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