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Not yet recruiting NCT07567183

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

No phase Interventional Bruxism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Connective tissue massage, Classic massage, Occlusal Splint Group.
Who it may be relevant to
Registry conditions: Bruxism. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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, slo
  • Other 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 mu
  • Other 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 b

Primary outcome measures

  • Visual Analog Scale (VAS) [Time frame: Before intervention, 4th week and 8th week after intervention]
  • Analysis of Jaw Muscle Tone and Stiffness [Time frame: Before intervention, 4th week and 8th week after intervention]
  • Oral Habits [Time frame: Before intervention, 4th week and 8th week after intervention]
  • Jaw Functional Restriction [Time frame: Before intervention, 4th week and 8th week after intervention]
  • Sleep Quality [Time frame: Before intervention, 4th week and 8th week after intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07567183 · IstanbulOkanUnive

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗