Comparison of the Effects of Different Massage Techniques in Individuals With Bruxism
28. dubna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
42
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Kübra Kendal, PhD
- Telefonní číslo: +90 530-233-8078
- E-mail: kubra.kendal@okan.edu.tr
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Aktivní komparátor: 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.
|
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Visual Analog Scale (VAS)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. května 2026
Primární dokončení (Odhadovaný)
1. července 2026
Dokončení studie (Odhadovaný)
1. září 2026
Termíny zápisu do studia
První předloženo
28. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
28. dubna 2026
První zveřejněno (Aktuální)
5. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
5. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. dubna 2026
Naposledy ověřeno
1. dubna 2026
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