Comparative evaluation of efficacy of 12.5% Vs 25% Dextrose Prolotherapy on Temporomandibular joint dysfunction – A Single blind Randomized controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Efficacy of 12.5 percent versus 25 percent dextrose prolotherapy on temperomandibular joint dysfunction on pain using VAS scale, maximum mouth opening using interincisal distance, TMJ tenderness checked by palpation, presence or absence of TM joint sounds(clicking/crepitations) checked by palpation.
研究概览
简要总结
This is a single-center, single-blind, randomized controlled trial evaluating the comparative efficacy of 12.5% versus 25% dextrose prolotherapy in patients with temporomandibular joint dysfunction. The study aims to assess improvement in pain, joint function, and joint sounds over a 3-month follow-up period using validated outcome measures such as the Visual Analog Scale (VAS), maximum interincisal opening, and presence of TMJ clicking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 to 50 years diagnosed with TMD.
- •Patients ready to give informed consent and willingness to comply with follow-up visits.
- •Presence of persistent TMJ pain for more than 3 months.
- •Limited jaw mobility or joint noises (clicking, crepitations) associated with TMD.
- •Has not undergone any prior treatment for TMD.
排除标准
- •History of TMJ surgery or severe TMJ degenerative disease.
- •Presence of systemic inflammatory conditions (e.g., rheumatoid arthritis, lupus) or blood dyscrasias are excluded from the study.
- •Recent use of corticosteroid injections.
- •Pregnancy or lactation.
- •Active infection or tumor in the injection site.
- •Severe psychiatric disorders that may affect pain perception and compliance.
结局指标
主要结局
Efficacy of 12.5 percent versus 25 percent dextrose prolotherapy on temperomandibular joint dysfunction on pain using VAS scale, maximum mouth opening using interincisal distance, TMJ tenderness checked by palpation, presence or absence of TM joint sounds(clicking/crepitations) checked by palpation.
时间窗: Post operative 2 weeks, 4 weeks, 1 month and 3 months
次要结局
- 1. Presence or absence of deviation during mouth opening.
- 2. Any adverse events related to injection (swelling, prolonged pain)(Within 48 hours and at each follow up)
研究者
Dr Jyothsna M
KVG Dental College and Hospital