NCT07567183

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Study Progress5%
May 2026Sep 2026

First Submitted

Initial submission to the registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 28, 2026

Last Update Submit

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 COMPARATOR

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.

Other: Classic massage

Connective Tissue Massage Group (CMM)

ACTIVE COMPARATOR

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.

Other: Connective tissue massage

Occlusal Splint Group (OS)

ACTIVE COMPARATOR

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.

Other: Occlusal Splint Group

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.

Connective Tissue Massage Group (CMM)

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.

Classical Massage Group (CM)

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.

Occlusal Splint Group (OS)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

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
Model Details: Randomized controlled study
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