Device for Alleviating Temporomandibular Joint (TMJ) Pain
2026년 5월 29일 업데이트: BTL Industries Ltd.
Evaluating the Safety and Efficacy of the BTL-043 Device in Alleviating Temporomandibular Joint (TMJ) Pain
The goal of this clinical trial is to evaluate the safety and effectiveness of the investigational BTL-043 device in alleviating Temporomandibular Joint (TMJ) pain in adults aged 22 years and older. The main questions it aims to answer are:
Does the BTL-043 device effectively reduce TMJ pain? Does the treatment improve jaw mobility (mandibular range of motion) and reduce the impact of TMJ disorders on daily activities? Is the treatment comfortable and safe for participants?
Participants will:
Receive four 20-minute treatments with the BTL-043 laser, spaced 2 to 10 days apart.
Attend follow-up clinic visits 1 month and 3 months after their final treatment.
Complete questionnaires about their pain levels (Visual Analogue Scale), daily activities (TMD Disability Index), and treatment comfort and satisfaction.
Have their jaw mobility (mandibular range of motion) measured
연구 개요
연구 유형
중재적
등록 (실제)
31
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Colorado
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Steamboat Springs, Colorado, 미국, 80487
- McCreight Progressive Dentistry
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Florida
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Leesburg, Florida, 미국, 34748
- The Dental Touch
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Ocala, Florida, 미국, 34471
- Chandra Wellness Center
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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
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adults seeking alleviation of pain in the treatment area
- Age 22 years and older
- Voluntarily signed an informed consent form
- Subject is willing to comply with study instructions, to return to the clinic for the required visits
- Willingness to adhere to and continue current pain management plan
- Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without affecting significant change during study participation
- Subject willing and able to abstain from partaking in any new treatments other than this study procedure to treat TMJ pain
- Women of child-bearing potential* are required to use birth control measures during the whole duration of the study *Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Exclusion Criteria:
- Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus
- Current pregnancy
- Photosensitivity, medications affecting sensitivity to light
- Tattoos or other higher pigmented regions in the treated area
- Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use
- Anticoagulant therapy, bleeding disorders
- Hemorrhage in the treated area
- Application over the thyroid or other endocrine glands
- Application within 4 to 6 months after radiotherapy
- Known or suspected malignancy, history of cancer or any type of malignancy
- Febrile conditions, serious illness, chronic infection
- Epilepsy
- Sensory loss in the treatment area
- Deep vein thrombosis
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Treatment with BTL-043
Four (4) treatment sessions will be applied to the subjects' temporomandibular joint (TMJ) area using the BTL-043 device.
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Four (4) treatment sessions will be applied to the subjects' temporomandibular joint (TMJ) area using the BTL-043 system (a Class IV laser operating at a 1064 nm wavelength).
Each treatment session lasts 20 minutes and is spaced 2 to 10 days apart.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months
기간: Baseline and 3 months
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The Visual Analogue Scale (VAS) is a self-reported measure used to assess the intensity of TMJ-related pain experienced by the participants in the treatment area.
Participants rate their perceived pain level on a numerical scale ranging from 0 to 10.
On this scale, 0 is equivalent to "no pain" and 10 indicates the "worst possible pain".
The baseline score is compared to the score collected at the 3-month follow-up visit.
A negative change from baseline (a decrease in the VAS score) indicates a reduction in pain intensity and an improvement in the participant's condition over time.
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Baseline and 3 months
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Change from Baseline in the Temporomandibular Dysfunction (TMD) Disability Index Score at 3 Months
기간: Baseline and 3 months
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The Temporomandibular Dysfunction (TMD) Disability Index is a self-reported questionnaire used to assess the impact of TMJ disorders on a participant's daily activities, such as talking, chewing, and sleeping.
The questionnaire consists of 10 categories, each containing 5 statements.
Each category is scored on a scale from 0 to 4, where 0 represents no limitation and 4 represents maximum restriction due to pain.
The overall score is calculated by summing the scores of all 10 items, resulting in a total possible score ranging from 0 to 40.
On this scale, a total score of 0 indicates no disability and 40 indicates extreme disability.
A negative change from baseline (a decrease in the total score) indicates a reduction in disability and an improvement in the participant's condition over time.
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Baseline and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Mandibular Range of Motion at 3 Months
기간: Baseline and 3 months
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Mandibular range of motion is measured objectively in millimeters (mm) using a specialized scale.
Two measurements are taken: "comfort" (opening the mouth to a comfortable level without pain) and "active" (opening the mouth as wide as possible despite the presence of pain).
A positive change from baseline (an increase in the measured mm) indicates an improvement in jaw mobility.
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Baseline and 3 months
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Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire
기간: 3 months post treatment
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Subject satisfaction with the treatment outcomes and its impact on quality of life is assessed using a 13-item self-reported questionnaire.
Each item is rated on a 5-point Likert scale, where 1 indicates "strongly disagree" and 5 indicates "strongly agree".
Higher scores represent greater treatment satisfaction and improvement in the subject's quality of life.
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3 months post treatment
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Therapy Comfort Assessed by the Therapy Comfort Questionnaire
기간: Immediately after the final (fourth) treatment
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Therapy comfort is assessed using a self-reported questionnaire.
Participants indicate their overall comfort on a 5-point Likert scale (where 1 is "strongly disagree" and 5 is "strongly agree" with the statement "I found the treatment comfortable").
Additionally, any pain experienced during treatment is rated on a Numerical Analogue Scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Lower pain scores and higher agreement scores indicate greater therapy comfort.
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Immediately after the final (fourth) treatment
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Incidence of Treatment-related Adverse Events
기간: From baseline up to 3 months post-treatment
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Overall safety is evaluated continuously by monitoring, assessing, and recording the occurrence and severity of any adverse events, side effects, or unanticipated problems throughout the course of the study
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From baseline up to 3 months post-treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2024년 8월 21일
기본 완료 (실제)
2025년 5월 14일
연구 완료 (실제)
2025년 5월 14일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 5월 29일
처음 게시됨 (실제)
2026년 6월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
2026년 5월 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. .