- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07677228
Telerehabilitation Versus Home-Based Jaw Exercises in Temporomandibular Disorder With Bruxism (TELEROC)
24. juni 2026 opdateret af: Mehmet Turgut
Effectiveness of Telerehabilitation-Based Rocabado Exercises Compared With Home-Based Rocabado Exercises in Patients With Myofascial Temporomandibular Dysfunction Accompanied by Bruxism: A Randomised Controlled Trial
This study looked at whether jaw exercises (the Rocabado exercise programme) work better when delivered through supervised online video sessions than when done at home with written instructions alone, in adults who have jaw-joint pain (temporomandibular disorder) together with teeth grinding (bruxism).
Thirty adults were randomly placed into one of two groups.
Both groups were taught the same exercises and asked to do them twice a day for four weeks.
One group also took part in supervised video sessions three times a week, where a physiotherapist watched their exercises and gave feedback; the other group used printed exercise leaflets with weekly text-message reminders.
The researchers measured jaw pain, how wide participants could open their mouth, jaw movement, stress, sleep quality and oral habits before treatment, after two weeks and after four weeks, to see which approach gave better results.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This single-centre, parallel-group, randomised controlled trial was conducted at the Faculty of Dentistry, Nevşehir Hacı Bektaş Veli University.
Participants who met the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for myofascial temporomandibular disorder with concurrent bruxism were randomly allocated in a 1:1 ratio using a computer-generated simple randomisation sequence.
Allocation was concealed using sequentially numbered, opaque, sealed envelopes that were opened only after enrolment.
The outcome assessor was blinded to group allocation; participants were not blinded owing to the nature of the intervention.
Both groups received identical initial face-to-face training in the Rocabado 6×6 exercise programme and were instructed to perform the exercises twice daily for four weeks.
The telerehabilitation group additionally received supervised video sessions, whereas the comparator group followed the programme at home with printed materials and reminders only.
Assessments were performed in person at baseline, at week 2 (mid-treatment) and at week 4 (post-treatment).
The sample size was estimated using G*Power, and data were analysed with within-group and between-group statistical comparisons.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Nevşehir Province
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Nevşehir, Nevşehir Province, Tyrkiet (Türkiye), 50300
- Nevşehir Hacı Bektaş Veli University, Faculty of Dentistry
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Adults aged 18-60 years
- Diagnosis of myofascial temporomandibular disorder (TMD) with bruxism according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- Visual Analogue Scale (VAS) pain score ≥ 3
- No medical treatment for TMD in the preceding 6 months
- Access to a smartphone with internet connectivity
- Turkish literacy and communication ability
Exclusion Criteria:
- Active orthodontic or splint treatment
- History of temporomandibular joint surgery
- Systemic inflammatory disease
- Pregnancy
- Major psychiatric disorders
- Neurological deficits in the cervical region
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Telerehabilitation group
Participants received supervised Rocabado 6×6 exercise training through video sessions delivered via WhatsApp three times per week, with real-time physiotherapist feedback, in addition to performing the Rocabado exercises at home twice daily for four weeks.
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Supervised Rocabado 6×6 exercise programme delivered through video sessions via WhatsApp three times per week, with real-time physiotherapist feedback on exercise performance and technique, performed in addition to twice-daily home Rocabado exercises for four weeks.
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Aktiv komparator: Home exercise group
Participants performed the same Rocabado 6×6 exercise programme at home twice daily for four weeks, supported by printed exercise brochures and weekly SMS reminders, without supervised video sessions.
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Rocabado 6×6 exercise programme performed at home twice daily for four weeks, supported by printed exercise brochures and weekly SMS reminders, without supervised video sessions or physiotherapist feedback.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain intensity (Visual Analogue Scale)
Tidsramme: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
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Pain intensity assessed using the Visual Analogue Scale (VAS), scored from 0 to 10 cm, for morning pain, pain during chewing (mastication) and night pain.
Higher scores indicate greater pain.
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Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
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Maximum mouth opening
Tidsramme: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
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Maximum mouth opening measured in millimetres using a digital calliper (Mitutoyo, Japan); the mean of three consecutive measurements was recorded.
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Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Temporomandibular joint range of motion
Tidsramme: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
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Active and passive maximum mouth opening, right and left lateral movements, and protrusion measured in millimetres using a digital calliper (Mitutoyo, Japan).
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Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
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TMD severity (Fonseca Anamnestic Index)
Tidsramme: Baseline and week 4 (post-treatment)
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Severity of temporomandibular disorder assessed using the Fonseca Anamnestic Index (0-100 points); higher scores indicate greater severity.
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Baseline and week 4 (post-treatment)
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Perceived stress (Perceived Stress Scale)
Tidsramme: Baseline and week 4 (post-treatment)
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Perceived stress assessed using the Perceived Stress Scale (PSS-14), scored from 0 to 40; higher scores indicate greater perceived stress.
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Baseline and week 4 (post-treatment)
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Sleep quality (Jenkins Sleep Scale)
Tidsramme: Baseline and week 4 (post-treatment)
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Sleep quality assessed using the Jenkins Sleep Scale, scored from 0 to 20; higher scores indicate poorer sleep quality.
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Baseline and week 4 (post-treatment)
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Oral parafunctional habits (Oral Behaviours Checklist)
Tidsramme: Baseline and week 4 (post-treatment)
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Oral parafunctional habits assessed using the Oral Behaviours Checklist (OBC), scored from 0 to 40; higher scores indicate more frequent oral parafunctional behaviours.
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Baseline and week 4 (post-treatment)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Nevin Ergun, Sanko University
- Ledende efterforsker: Taha Turgut, Msc. PT., Nevşehir Hacı Bektaş Veli University
- Ledende efterforsker: Mehmet Turgut, Nevsehir Haci Bektas Veli University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Turgut T. Effectiveness of telerehabilitation-based Rocabado exercises compared to home-based Rocabado exercises in myofascial temporomandibular dysfunctions accompanied by bruxism [master's thesis]. Nevşehir: Nevşehir Hacı Bektaş Veli University; 2024.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. december 2023
Primær færdiggørelse (Faktiske)
20. juli 2024
Studieafslutning (Faktiske)
20. juli 2024
Datoer for studieregistrering
Først indsendt
24. juni 2026
Først indsendt, der opfyldte QC-kriterier
24. juni 2026
Først opslået (Faktiske)
30. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2300080935
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data are not made publicly available.
De-identified data generated and analysed during the study are available from the corresponding author on reasonable request, subject to institutional and ethical approval.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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