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临床试验/NCT04875650
NCT04875650已完成不适用

Comparison of Physics Forceps and Conventional Forceps in Extraction of Mandibular Molars: A Double-Blinded Randomized Controlled Trial

Melaka Manipal Medical College2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Incidence of Alveolar Bone Fracture

研究概览

简要总结

Our study compared two different forceps for extraction of mandibular molars, the conventional extraction forceps and the Physics forceps. We assesed the relative pain score, patient satisfaction, success of extraction, incidence of alveolar plate fracture and soft tissue healing; post extraction. Our results found statistical significance in comparison of both forceps under relative pain score, patient satisfaction and soft tissue healing post extraction.

详细描述

Abstract

  • INTRODUCTION/ BACKGROUND Tooth extractions are commonly done with conventional forceps. Recent advances like physics forceps help in atraumatic extractions by preserving the buccal plate, having less pain and better gingival healing. The buccal portion of the forceps is a plastic covered bumper which prevents reflection of buccal gingiva and buccal plate fracture. This is the first such comparison study to measure gingival healing in mandibular molar region with D2 bone quality.
  • OBJECTIVE To compare the efficacy of Physics Forceps and Conventional Forceps in extraction of mandibular molars by randomly dividing the patients in two groups. The efficacy is determined by comparing the success of extraction, relative pain score, incidence of alveolar fracture, patient satisfaction and soft tissue healing on 3rd post-operative day.
  • METHODOLOGY Patients who were indicated for extraction were included in the study. They were divided into two groups of 10 by double blinded randomization. Local Anesthesia was administered and the extraction was carried out using either Physics or Conventional forceps. Post extraction, the pain score was assessed using the VAS. Along with these, the gingival healing, success of extraction and alveolar plate fracture was assessed by the subject expert on the 3rd day post-operative day.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18-55 years
  • Mandibular molar teeth indicated for extractions with gingival index 1.

排除标准

  • Patients with uncontrolled systemic diseases, that compromise dental extraction
  • Mandibular 3rd Molars
  • Grade 2 and 3 mobile teeth
  • Grossly decayed mandibular molars

结局指标

主要结局

Incidence of Alveolar Bone Fracture

时间窗: Day 1

Fracture 1 and No fracture 0

Relative Pain Score

时间窗: Day 1

Use of a Visual Analogue Scale with 0 meaning no pain and 100 meaning severe pain

Soft Tissue Healing Post Extraction

时间窗: Day 3

Soft Tissue Healing Index by Landry et al.

Patient Satisfaction

时间窗: Day 1

4 point likert scale where 1 is very dissatisfied and 4 is very satisfied

Success of Extraction

时间窗: Day 1

1 is Failure, 2 is limited success with osteotomy, 3 is limited success with root fracture, 4 is limited success with apical fracture and 5 is complete success

次要结局

未报告次要终点

研究者

发起方
Melaka Manipal Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Auric Bhattacharya

Principal Investigator, Associate Professor

Melaka Manipal Medical College

研究点 (2)

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