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- Essai clinique NCT07677228
Telerehabilitation Versus Home-Based Jaw Exercises in Temporomandibular Disorder With Bruxism (TELEROC)
24 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Nevşehir Province
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Nevşehir, Nevşehir Province, Turquie (Türkiye), 50300
- Nevşehir Hacı Bektaş Veli University, Faculty of Dentistry
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain intensity (Visual Analogue Scale)
Délai: 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)
|
|
Maximum mouth opening
Délai: 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.
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Baseline, week 2 (mid-treatment) and week 4 (post-treatment)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Temporomandibular joint range of motion
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Nevin Ergun, Sanko University
- Chercheur principal: Taha Turgut, Msc. PT., Nevşehir Hacı Bektaş Veli University
- Chercheur principal: Mehmet Turgut, Nevsehir Haci Bektas Veli University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 décembre 2023
Achèvement primaire (Réel)
20 juillet 2024
Achèvement de l'étude (Réel)
20 juillet 2024
Dates d'inscription aux études
Première soumission
24 juin 2026
Première soumission répondant aux critères de contrôle qualité
24 juin 2026
Première publication (Réel)
30 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2300080935
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .