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- Klinische proef NCT07677228
Telerehabilitation Versus Home-Based Jaw Exercises in Temporomandibular Disorder With Bruxism (TELEROC)
24 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Nevşehir Province
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Nevşehir, Nevşehir Province, Turkije (Türkiye), 50300
- Nevşehir Hacı Bektaş Veli University, Faculty of Dentistry
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pain intensity (Visual Analogue Scale)
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Temporomandibular joint range of motion
Tijdsspanne: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Nevin Ergun, Sanko University
- Hoofdonderzoeker: Taha Turgut, Msc. PT., Nevşehir Hacı Bektaş Veli University
- Hoofdonderzoeker: Mehmet Turgut, Nevsehir Haci Bektas Veli University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 december 2023
Primaire voltooiing (Werkelijk)
20 juli 2024
Studie voltooiing (Werkelijk)
20 juli 2024
Studieregistratiedata
Eerst ingediend
24 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
24 juni 2026
Eerst geplaatst (Werkelijk)
30 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
24 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2300080935
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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