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Clinical Trials/NCT04875650
NCT04875650CompletedNot Applicable

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

Melaka Manipal Medical College2 sites in 1 country20 target enrollmentStarted: December 2, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
Incidence of Alveolar Bone Fracture

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Incidence of Alveolar Bone Fracture

Time Frame: Day 1

Fracture 1 and No fracture 0

Relative Pain Score

Time Frame: Day 1

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

Soft Tissue Healing Post Extraction

Time Frame: Day 3

Soft Tissue Healing Index by Landry et al.

Patient Satisfaction

Time Frame: Day 1

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

Success of Extraction

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Melaka Manipal Medical College
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Auric Bhattacharya

Principal Investigator, Associate Professor

Melaka Manipal Medical College

Study Sites (2)

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