跳至主要内容
临床试验/CTRI/2025/07/090395
CTRI/2025/07/090395招募中不适用

A Comparative Clinical Evaluation of Piezo Surgical System Versus Conventional Drilling Techniques in Healing Outcomes Following Tooth Extraction in Patients with Oral Submucous Fibrosis: A Randomized Controlled Trial.

Dr Jyot Sarvaiya1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月17日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

A study titled as a comparative clinical evaluation of piezo surgical system versus conventional drilling techniques in healing outcomes following tooth extraction in patients with oral submucous fibrosis, a randomized controlled trial compares piezoelectric surgical system with conventional drilling techniques in mandibular third molar extraction in patients with oral submucous fibrosis. Oral submucous fibrosis can complicate third molar extraction due to fibrosis and limited mouth opening. The primary outcome of the study is to evaluate post operative pain, swelling and wound healing and secondary outcome of the study is to evaluate intra operative patient reported comfort, acceptability and duration of operative intervention during extraction. Sixty patients diagnosed with oral submucous fibrosis are randomly assigned to either group. Piezoelectric surgery uses ultrasonic vibrations for precise bone cutting, reducing tissue damage and bleeding, while conventional drilling can cause more trauma.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed with oral sub mucous fibrosis Age between 25 to 60 years Mouth Opening between 15mm to 35mm Mandibular third molar teeth indicated for surgical extraction(Pederson score: Slightly difficult and moderately diffiicult[3-6] Patient willing to participate in the study and available for long term follow up Teeth cannot be saved endodontically.

排除标准

  • Patients with cardiac pacemakers Patients with systemic diseases(ASA-2, ASA-3, ASA-4) Age less than 25 years and greater than 60 years Patients with bleeding and clotting disorders Patients with a history of allergies or adverse effects to local aesthetic agents.

结局指标

主要结局

Postoperative pain

时间窗: 1st 3rd and 7th days

Swelling

时间窗: 1st 3rd and 7th days

Wound Healing

时间窗: 1st 3rd and 7th days

次要结局

  • Intraoperative(Patient reported comfort)

研究者

发起方
Dr Jyot Sarvaiya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Jyot Sarvaiya

Government Dental College and Hospital

研究点 (1)

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