Comparison of 3D Printed Occlusal Splint Versus Conventional Occlusal Splint in Treating Temporomandibular Joint Disorder Utilizing Advanced Digital Assessment Techniques - A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual Analogue scale (VAS)
研究概览
简要总结
Temporomandibular Disorders (TMD) affect jaw movement, causing pain and discomfort. Treatment often involves occlusal splints, traditionally made with heat-cured acrylic. Advancements in 3-D printing offer new possibilities, but their effectiveness needs evaluation. Current research relies on subjective measures, lacking objective tools like T-Scan and Joint Vibration Analysis. Comparing conventional techniques with 3-D printed splints could provide insights into treatment success. Thus, a thorough assessment is necessary before transitioning to digital workflows in removable prosthetics. The aim of this study was to compare and evaluate the effectiveness of 3D printed occlusal splints to conventional occlusal splints in treating Temporomandibular Joint Disorder, utilizing advanced digital evaluation tools in a human trial. Specifically, the objectives were to compare the performance of 3D printed occlusal splints with conventional ones using advanced digital tools like JVA and T-scan, assess the efficiency of 3D printed occlusal splints in managing TMJ disorders, and measure TMJ pain levels using the visual analogue scale. The study was designed as a blinded crossover randomized controlled trial in accordance with the CONSORT guidelines. Twenty patients requiring occlusal splint therapy were included in the study based on the selected inclusion and exclusion criteria. Patients were divided into two groups. Each group received stabilization occlusal splint, one fabricated using conventional compression molding technique and the other using 3D printing technique with a 2-week follow-up period. The outcome measures were Pain assessment using VAS, occlusal contacts using T-scan, and TMJ health assessment using JVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants between the ages of 18 and 65 years.
- •2.Participants with disc displacement.
- •3.Participants with generalized dental attrition or loss of VDO or sensitivity due to loss of occlusal enamel.
- •4.Patient with full arch dentition.
- •5.No active periodontal disease.
- •6.Participants with good general health.
- •7.Participants who have given written informed consent to participate in the study.
排除标准
- •1.Participants with a known allergy to Polymethylmethacrylate.
- •2.Participants with systemic diseases affecting the oral cavity, such as uncontrolled diabetes, autoimmune diseases, or cancer.
- •3.Patient with impacted, partially erupted third molars.
- •4.Pregnant or breastfeeding women.
- •5.Participants with a history of mental illness or cognitive impairment.
- •6.Participants with history of recent multiple teeth extractions.
- •7.Participants with a history of severe periodontal disease or tooth mobility.
- •8.Participants with missing teeth that require immediate restoration.
- •9.Participants who are unable to comply with the study protocol or attend follow-up visits.
结局指标
主要结局
Visual Analogue scale (VAS)
时间窗: Baseline, 3 weeks
次要结局
- T Scan evaluation(Baseline, 3 weeks)
- Joint Vibration Analysis (JVA)(Baseline, 3 weeks)
- Chair Time(Insertion day)
研究者
Maaz Maksood Vohra
Saveetha Dental College