- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07677228
Telerehabilitation Versus Home-Based Jaw Exercises in Temporomandibular Disorder With Bruxism (TELEROC)
24. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Nevşehir Province
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Nevşehir, Nevşehir Province, Türkei (türkiye), 50300
- Nevşehir Hacı Bektaş Veli University, Faculty of Dentistry
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
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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Aktiver 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pain intensity (Visual Analogue Scale)
Zeitfenster: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
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.
|
Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
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Maximum mouth opening
Zeitfenster: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
Maximum mouth opening measured in millimetres using a digital calliper (Mitutoyo, Japan); the mean of three consecutive measurements was recorded.
|
Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Temporomandibular joint range of motion
Zeitfenster: 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).
|
Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
|
TMD severity (Fonseca Anamnestic Index)
Zeitfenster: Baseline and week 4 (post-treatment)
|
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)
Zeitfenster: 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.
|
Baseline and week 4 (post-treatment)
|
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Sleep quality (Jenkins Sleep Scale)
Zeitfenster: 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)
Zeitfenster: 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.
|
Baseline and week 4 (post-treatment)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Nevin Ergun, Sanko University
- Hauptermittler: Taha Turgut, Msc. PT., Nevşehir Hacı Bektaş Veli University
- Hauptermittler: Mehmet Turgut, Nevsehir Haci Bektas Veli University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Dezember 2023
Primärer Abschluss (Tatsächlich)
20. Juli 2024
Studienabschluss (Tatsächlich)
20. Juli 2024
Studienanmeldedaten
Zuerst eingereicht
24. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. Juni 2026
Zuerst gepostet (Tatsächlich)
30. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
30. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2300080935
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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