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Comparison of the Effects of Different Massage Techniques in Individuals With Bruxism

28 aprile 2026 aggiornato da: Kübra Kendal, Okan University

Comparison of the Effects of Different Massage Techniques on Pain, Orofacial Muscle Characteristics, Disability, and Sleep Quality in Individuals With Bruxism

The aim of this study is to compare the effects of occlusal splint therapy and different massage techniques on pain intensity and orofacial muscle tone and stiffness in individuals with possible sleep bruxism. A secondary aim is to evaluate the effects of these interventions on oral parafunctional behaviors, disability, and sleep quality.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Individuals meeting the inclusion criteria will be randomly assigned to three groups using block randomization: classic massage group (CM), connective tissue massage group (CTM), and occlusal splint group (OCG). Following their assessments, individuals will be assigned to their respective groups. The CM and CTM groups will receive different massage techniques twice a week from a physiotherapist for four weeks, while the OCG group will be instructed to use a custom-made occlusal splint provided by a dentist for four weeks. Assessments will be repeated for all individuals at the 4th and 8th weeks.

Tipo di studio

Interventistico

Iscrizione (Stimato)

42

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Possible diagnosis of sleep bruxism,
  • Reporting jaw or chewing muscle pain within the last 3 months

Exclusion Criteria:

  • Having any orthopedic, neurological, or psychiatric diagnosis,
  • Having systemic and/or degenerative disorders,
  • Neurological or psychiatric disorders (excluding anxiety and depression),
  • Using medications that affect sleep or motor behavior,
  • Having arthrogenic or mixed temporomandibular disorders,
  • Using an intraoral prosthesis,
  • Having a history of direct trauma or previous surgery in the orofacial region,
  • Using muscle relaxants and non-steroidal anti-inflammatory drugs,
  • Using a removable prosthesis,
  • Receiving any treatment for bruxism within the last 4 weeks.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Classical Massage Group (CM)
The classic massage treatment will be planned to include superficial and deep manual techniques targeting the facial and chewing muscles. Prior to the treatment, the individual will be positioned supine in a comfortable position. The massage protocol will include effleurage (superficial stroking), petrissage (kneading), friction (circular deep pressure), and gentle vibration techniques. The application will be performed bilaterally, targeting the masseter, temporalis, buccinator, and perioral muscle groups. Pressure intensity will be adjusted according to the individual's tolerance, avoiding pain provocation. Each session will last approximately 30 minutes and will be performed twice a week for a total of 4 weeks.
Altro: Classic massage
The classic massage treatment will be planned to include superficial and deep manual techniques targeting the facial and chewing muscles. Prior to the treatment, the individual will be positioned supine in a comfortable position. The massage protocol will include effleurage (superficial stroking), petrissage (kneading), friction (circular deep pressure), and gentle vibration techniques. The application will be performed bilaterally, targeting the masseter, temporalis, buccinator, and perioral muscle groups. Pressure intensity will be adjusted according to the individual's tolerance, avoiding pain provocation. Each session will last approximately 30 minutes and will be performed twice a week for a total of 4 weeks.
Comparatore attivo: Connective Tissue Massage Group (CMM)
Connective tissue massage will be planned to include reflex-activated manual techniques targeting the subcutaneous connective tissue in the face and mandibular region. The individual will be positioned supine, and the application will be performed using specific skin-tightening maneuvers that create gliding between the skin and subcutaneous tissues. The techniques will focus particularly on connective tissue areas around the masseter, temporalis, and mandibular ramus. During the application, slow and controlled maneuvers aimed at creating tension in the connective tissue rather than deep mechanical pressure will be preferred. Each session will last approximately 30 minutes and will be applied twice a week for a total of 4 weeks.
Altro: Connective tissue massage
Connective tissue massage will be planned to include reflex-activated manual techniques targeting the subcutaneous connective tissue in the face and mandibular region. The individual will be positioned supine, and the application will be performed using specific skin-tightening maneuvers that create gliding between the skin and subcutaneous tissues. The techniques will focus particularly on connective tissue areas around the masseter, temporalis, and mandibular ramus. During the application, slow and controlled maneuvers aimed at creating tension in the connective tissue rather than deep mechanical pressure will be preferred. Each session will last approximately 30 minutes and will be applied twice a week for a total of 4 weeks.
Comparatore attivo: Occlusal Splint Group (OS)
Individuals in the OS group will have an occlusal splint fitted by the dental department and will be provided with guidance on lifestyle changes to be considered in daily living activities. Following a clinical examination by the dentist, an impression will be taken of each volunteer's upper dental arch using irreversible hydrocolloid and used to prepare a maxillary Michigan type occlusal splint. Volunteers will be instructed to wear the splint while sleeping and the necessary adjustments will be made by the same dentist after two weeks.
Altro: Occlusal Splint Group
Individuals in the OS group will have an occlusal splint fitted by the dental department and will be provided with guidance on lifestyle changes to be considered in daily living activities. Following a clinical examination by the dentist, an impression will be taken of each volunteer's upper dental arch using irreversible hydrocolloid and used to prepare a maxillary Michigan type occlusal splint. Volunteers will be instructed to wear the splint while sleeping and the necessary adjustments will be made by the same dentist after two weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Analog Scale (VAS)
Lasso di tempo: Before intervention, 4th week and 8th week after intervention
The VAS is a widely validated and reliable measurement tool developed to quantitatively assess an individual's perception of pain. It is typically designed as a straight line approximately 10 cm long; the left end of the line represents "no pain," and the right end represents "very severe/unbearable pain." Participants indicate the pain they feel by marking a point on the line as they see fit. The value obtained by measuring the marked point numerically expresses the individual's pain level. This scale was chosen for this study due to its ease of application, sensitivity, and widespread acceptance in clinical and research settings.
Before intervention, 4th week and 8th week after intervention
Analysis of Jaw Muscle Tone and Stiffness
Lasso di tempo: Before intervention, 4th week and 8th week after intervention
Using the Myoton Pro device, physical characteristics such as tone (F) and stiffness (S) of the upper trapezius, sternocleidomastoid, and masseter muscles will be measured. These measurements will help determine the adaptations that bruxism creates in the soft tissues.
Before intervention, 4th week and 8th week after intervention
Oral Habits
Lasso di tempo: Before intervention, 4th week and 8th week after intervention
The 21-item Oral Habits Checklist (OHAC) will be used to assess participants' oral parafunctional behaviors. The questionnaire, which asks about the frequency of parafunctional habits such as teeth clenching, teeth grinding, nail biting, lip biting, cheek biting, pen chewing, and gum chewing in the past month, will be answered using a 4-point Likert scale.
Before intervention, 4th week and 8th week after intervention
Jaw Functional Restriction
Lasso di tempo: Before intervention, 4th week and 8th week after intervention
The 'Jaw Functional Restriction Scale-8' (CFRS) will be used for functional assessment. Individuals will be asked to determine their level of restriction for each of the 8 items on the scale within the last month. Individuals will be informed that on a 10 cm horizontal line, the number '0' represents 'no restriction' and the number '10' represents 'severe restriction'. The average of the individual's answers will be taken to calculate the functional restriction.
Before intervention, 4th week and 8th week after intervention
Sleep Quality
Lasso di tempo: Before intervention, 4th week and 8th week after intervention
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. PSQI items are structured based on clinical observations of individuals with sleep disorders, existing sleep quality scales referenced in the literature, and 18-month clinical follow-up findings focusing on the PSQI.
Before intervention, 4th week and 8th week after intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Okan University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 luglio 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IstanbulOkanUnive

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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