跳至主要内容
临床试验/CTRI/2025/05/087448
CTRI/2025/05/087448尚未招募不适用

Comparative Clinical Evaluation of Piezoelectric Surgical System Versus Conventional Methods in the Healing Outcomes After Tooth Extraction in Patients with Oral Cancer: A Double-Blind Randomized Controlled Trial Study

Government Dental College And Hospital Jamnagar1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年6月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Wound healing evaluation

研究概览

简要总结

THE AIM OF THE STUDY IS TO SEE WHICH METHOD IS BETTER BY LOOKING AT PAIN, SWELLING, HEALING, AND OTHER PROBLEM AFTER THE SURGERY; IT’S IMPORTANT BECAUSE IT HELPS DOCTOR DECIDE WHICH METHOD TO USE BY LOOKING AT THE GOOD AND BAD SIDES OF EACH TECHNIQUES. THE STUDY IS WELL ORGANIZED, WITH ORAL CANCER PALTENTS BETWEEN 25 TO 60 YEARS OLD WHO NEED A TOOTH EXTRACION WILL BE INCLUDED IN STUDY. SOME PEOPLE CAN’T JOIN THE STUDY, LIKE THOSE WITH HEART PACEMAKERS OR WHO ARE TOO YOUNG OR TOO OLD. THE STUDY HAS TWO GROUPS: ONE USES A GENTLE CUTTING TOOL WITH SOUND WAVES WHICH PIEZOELECTRIC MACHINE THAT’S SAFER FOR SOFT TISSUES AND THE OTHER USES TRADITIONAL DENTAL DRILLS THAT ARE MORE COMMON BUT MIGHT HURT TISSUES MORE. THE PATIENTS DON’T KNOW WHICH METHOD IS USED ON THEM AND THE PEOPLE CHECKING THE RESULTS. DON’T KNOW EITHER, THEY JOINTLY LOOK AT HOW WELL THE WOUND HEALS AFTER 4, 7 AND 14 DAYS AND ALSO CHECK PAIN AND SWELLING THEY USE SPECIAL STATISTICS TO MAKE SURE THE RESULTS ARE RELIABLE THE STUDY IS VALUABLE BECAUSE TS GIVES NEW INFORMATION ON HOW TO EXTRACT THE TEETH IN PEOPLE WTH ORAL CANCER, WHICH CAN HELP IN MAKING BETTER TREATMENT DECISIONS

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 and Outcome Assessor Blinded

入排标准

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

入选标准

  • Diagnosed with oral cancer Mouth opening 15mm-40mm Lower molar teeth indicated for extraction Tooth/teeth cannot be extracted by closed method Willingness to participate Tooth/teeth cannot be saved endodontically.

排除标准

  • Cardiac pacemaker Ongoing chemotherapy Age less than 20 YEARS or more than 60 years Bleeding/clotting disorders Allergies to local anesthetics Cardiomyopathy.

结局指标

主要结局

Wound healing evaluation

时间窗: days 4, 7, and 14

次要结局

  • Postoperative pain evaluated daily using VAS(Postoperative swelling time taken for extraction, excluding suturing)

研究者

发起方
Government Dental College And Hospital Jamnagar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nishit Kumar

Government dental college and hospital Jamnagar

研究点 (1)

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