- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07567183
Comparison of the Effects of Different Massage Techniques in Individuals With Bruxism
28. April 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
42
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Kübra Kendal, PhD
- Telefonnummer: +90 530-233-8078
- E-Mail: kubra.kendal@okan.edu.tr
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:
- 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.
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: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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.
|
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.
|
|
Aktiver Komparator: 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.
|
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.
|
|
Aktiver Komparator: 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Visual Analog Scale (VAS)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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 (Geschätzt)
1. Mai 2026
Primärer Abschluss (Geschätzt)
1. Juli 2026
Studienabschluss (Geschätzt)
1. September 2026
Studienanmeldedaten
Zuerst eingereicht
28. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. April 2026
Zuerst gepostet (Tatsächlich)
5. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IstanbulOkanUnive
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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