Comparison of the Effects of Different Massage Techniques in Individuals With Bruxism
1 other identifier
interventional
42
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
May 5, 2026
April 1, 2026
2 months
April 28, 2026
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Visual Analog Scale (VAS)
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
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
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
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
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
Study Arms (3)
Classical Massage Group (CM)
ACTIVE COMPARATORThe 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.
Connective Tissue Massage Group (CMM)
ACTIVE COMPARATORConnective 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.
Occlusal Splint Group (OS)
ACTIVE COMPARATORIndividuals 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Possible diagnosis of sleep bruxism,
- Reporting jaw or chewing muscle pain within the last 3 months
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Okan Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants will be blind to groups, outcomes assessor will be blind to groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
April 28, 2026
First Posted
May 5, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share