- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07567183
Comparison of the Effects of Different Massage Techniques in Individuals With Bruxism
2026년 4월 28일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
42
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kübra Kendal, PhD
- 전화번호: +90 530-233-8078
- 이메일: kubra.kendal@okan.edu.tr
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
|
활성 비교기: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Visual Analog Scale (VAS)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2026년 7월 1일
연구 완료 (추정된)
2026년 9월 1일
연구 등록 날짜
최초 제출
2026년 4월 28일
QC 기준을 충족하는 최초 제출
2026년 4월 28일
처음 게시됨 (실제)
2026년 5월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 28일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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