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NCT Number: NCT07567183

Comparison of the Effects of Different Massage Techniques 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.

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Key information

Conditions

Bruxism Behavior Habits Stomatognathic Diseases Tooth Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Connective Tissue Massage

Other

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.

classic massage

Other

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.

Occlusal Splint Group

Other

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.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 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.

  2. Analysis of Jaw Muscle Tone and Stiffness

    Time frame: 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.

  3. Oral Habits

    Time frame: 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.

  4. Jaw Functional Restriction

    Time frame: 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.

  5. Sleep Quality

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kübra Kendal, PhD

CONTACT

[email protected]

+90 530-233-8078

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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