Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars

Sponsor
Melaka Manipal Medical College (Other)
Overall Status
Completed
CT.gov ID
NCT04875650
Collaborator
(none)
20
1
2
4.6
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Extraction of Mandibular Molar using Physics Forceps
  • Procedure: Extraction of Mandibular Molar using Conventional Forceps
N/A

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
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Physics Forceps and Conventional Forceps in Extraction of Mandibular Molars: A Double-Blinded Randomized Controlled Trial
Actual Study Start Date :
Dec 2, 2020
Actual Primary Completion Date :
Apr 20, 2021
Actual Study Completion Date :
Apr 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physics Forceps

Procedure: Extraction of Mandibular Molar using Physics Forceps
Extraction of mandibular molars using physics forceps

Other: Conventional Forcep

Procedure: Extraction of Mandibular Molar using Conventional Forceps
Extraction of mandibular molars using conventional forceps

Outcome Measures

Primary Outcome Measures

  1. Relative Pain Score [Day 1]

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

  2. Soft Tissue Healing Post Extraction [Day 3]

    Soft Tissue Healing Index by Landry et al.

  3. Patient Satisfaction [Day 1]

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

  4. Success of Extraction [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

  5. Incidence of Alveolar Bone Fracture [Day 1]

    Fracture 1 and No fracture 0

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Melaka Manipal Medical College Melaka Malaysia 75150

Sponsors and Collaborators

  • Melaka Manipal Medical College

Investigators

  • Principal Investigator: Auric Bhattacharya, BDS, MDS, FICOI, MFDS, RCPS, Melaka Manipal Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Auric Bhattacharya, Principal Investigator, Associate Professor, Melaka Manipal Medical College
ClinicalTrials.gov Identifier:
NCT04875650
Other Study ID Numbers:
  • MMMC/FOD/AR/B8/E C-2020 (01)
First Posted:
May 6, 2021
Last Update Posted:
May 6, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 6, 2021