Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Comparative Efficacy of Conventional, 3D-Printed, and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders: A Randomized Clinical Trial
Occlusal splint therapy is a well-established conservative approach for the management of temporomandibular disorders (TMDs); however, variability in clinical outcomes suggests that no single splint design is universally optimal. Conventional chairside stabilization splints are widely used and allow immediate intraoral adjustments; however, they are technique-sensitive and may compromise long-term fit and patient comfort. Conversely, 3D-printed occlusal splints provide superior precision, reproducibility, and material stability; however, their uniformly rigid structure may limit initial comfort and patient compliance, particularly in patients with acute pain or muscle tenderness.
To address these limitations, the researchers intend to develop an innovative hybrid occlusal splint i.e. Dual material 3D printed stabilization splint, that integrates both hard and soft components. This design aims to combine the biomechanical stability and occlusal precision characteristic of rigid splints with the cushioning effect and enhanced comfort provided by soft splints. The objective is to improve adaptation, compliance, and the sustained therapeutic efficacy of the splint.
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dr. Subhadeepa Paul
- 전화번호: +918638461860
- 이메일: Subhadeepa01@gmail.com
연구 연락처 백업
- 이름: Dr. Harneet Singh, MDS
- 전화번호: +919315903300
- 이메일: drharneetomdr@gmail.com
연구 장소
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Haryana
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Rohtak, Haryana, 인도, 124001
- Post Graduate Institute of Dental Sciences, Rohtak
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연락하다:
- Dr. Harneet Singh, MDS
- 전화번호: +919034900501
- 이메일: drambikagupta79@rediffmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients presenting with clinical symptoms of TMJ pain disorders were diagnosed using the DC/TMD criteria.
- Age between 18 and 60.
- The same number of original molars was used to avoid affecting periodontal proprioception and bite force.
- The Patient's consent to participate in the study.
Exclusion Criteria:
- Pregnancy
- Not willing to participate in the study
- Healing disorders or systemic diseases where healing is compromised.
- Allergic to PMMA, TPU, PETG or any other 3D printing or conventional prosthetic material.
- Patients with epilepsy or any other neurological disorders.
- Systemic Arthritis or any other osteo-degenerative disorder.
- Acute TMJ trauma or fracture in < 30 days.
- Any obvious dental decay or periodontal disease to which fascial pain could be attributed.
- Patient with psychiatric disorder or on anti-anxiety or anti-depressant drugs.
- Patients with dental implants.
- Any systemic condition associated with widespread pain such as in fibromyalgia.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Conventional Stabilization Splints
Patients will be given conventional hard stabilization splints.
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Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.
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활성 비교기: 3D Printed stabilization splints
Patients will be given single material 3D printed stabilization splints made of PETG.
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3d printed stabilization splint for treatment of temporomandibular joint disorders.
다른 이름들:
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실험적: Hybrid Stabilization Splint
Patients will be given Novel Hybrid stabilization splints made of PETG and TPU.
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3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analog Scale (VAS)
기간: Baseline, 1 week, 2 weeks, 4 weeks
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To evaluate and contrast pain relief by using the Visual Analog Scale (VAS).The scale ranges from 0 to 10 where 0 is the minimum VAS score and 10 is the maximum score.
Score of 0 indicates no pain and score of 10 indicates maximum pain intensity.
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Baseline, 1 week, 2 weeks, 4 weeks
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Maximum Mouth Opening
기간: Baseline, 1 week, 2 weeks, 4 weeks
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To evaluate functional improvement by Measuring the change in Maximum Mouth Opening (MMO) in millimetres from baseline to 1 month.
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Baseline, 1 week, 2 weeks, 4 weeks
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Maximum Bite Force
기간: baseline, 1 week, 2 weeks, 4 weeks
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To quantify masticatory efficiency by measuring changes in Maximum Bite Force (MBF) using a bite force analyser device.
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baseline, 1 week, 2 weeks, 4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Compliance
기간: Baseline, 1 week, 2 weeks, 4 weeks
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To evaluate patient compliance and comfort using Likert Scale.
The Likert Scale is a 5-point scale where 1 is the minimum score and 5 is the maximum score.
Score 1 indicates very dissatisfied and Score 5 indicates very satisfied.
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Baseline, 1 week, 2 weeks, 4 weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: Dr. Harneet Singh, MDS, Post Graduate Institute of Dental Sciences, Rohtak
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Subhadeepa Omr 26/39
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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