Comparison of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Combination versus Injectable Platelet-Rich Fibrin Only in Internal Derangement Of Temporomandibular Joint: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 1.Pain at rest & chewing, assessed by means of a visual analog scale.
研究概览
简要总结
The aim of the study is to investigate the efficacy of combination of Hyaluronic acid, I-PRF and I-PRF alone in patients with internal derangements of the temporomandibular joint (TMJ).A total of 28 patients with tmj internal derangement will be selected from outpatient department of oral and maxillofacial surgery,vishnu dental college,bhimavaram, and will be equally divided into 2 groups of 14 each.in group-A arthrocentesis followed by i-prf injection and in group-B arthrocentesis followed by i-prf and hyaluronic acid combination.The study is interventional prospective study.computer generated randomization will be used as sampling method.The following primary outcomes
a) Pain at rest and chewing
b) Mandibular range of movement
c) Clicking
d) QOL questionnaire
d)functional limitation
will be measured at preoperative,1 week,1 month,3 months,6 months.
The data will be analyzed individually for all the patients.There is no conflict of interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients in the age group of 18-60 years.
- •2.Patients diagnosed with Wilkes stage II and III of ID of temporomandibular joint.
- •3.Patients not responding to conservative treatments.
- •4.Willingness to participate in the study and to give informed consent.
- •5.Willing for a minimum 6-month follow-up after undergoing treatment.
排除标准
- •1.Any systemic or malignant disease that could interfere with the TMJ treatment or assessment.
- •2.History of Previous TMJ surgery/condylar trauma.
- •3.Failure during intra-articular injection procedure.
- •4.Fibrous or osseous ankylosis of the TMJ.
- •5.Cutaneous, otic, or articular infections.
- •6.Edentulous patients.
- •7.Pregnant and breastfeeding.
- •8.Bilateral TMJ pain.
结局指标
主要结局
1.Pain at rest & chewing, assessed by means of a visual analog scale.
时间窗: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements.
时间窗: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
5.Functional limitation during usual jaw movements.
时间窗: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
3.Clicking by Auscultation.
时间窗: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
4.QOL questionnaire.
时间窗: 1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative. | 2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative. | 3.Clicking at 1 Week,1 month,3 months,6 months postoperative. | 4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative. | 5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative.
次要结局
- 1.Pain at rest & chewing, assessed by means of a visual analog scale.(2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements.)