Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars

Tooth Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875650
• Other study ID #: MMMC/FOD/AR/B8/E C-2020 (01)
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: April 20, 2021

Study information

• Verified date: May 2021
• Source: Melaka Manipal Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Extraction

Intervention

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

Locations

Country	Name	City	State
Malaysia	Melaka Manipal Medical College	Melaka

Sponsors (1)

Lead Sponsor	Collaborator
Melaka Manipal Medical College

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative Pain Score	Use of a Visual Analogue Scale with 0 meaning no pain and 100 meaning severe pain	Day 1
Primary	Soft Tissue Healing Post Extraction	Soft Tissue Healing Index by Landry et al.	Day 3
Primary	Patient Satisfaction	4 point likert scale where 1 is very dissatisfied and 4 is very satisfied	Day 1
Primary	Success of Extraction	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	Day 1
Primary	Incidence of Alveolar Bone Fracture	Fracture 1 and No fracture 0	Day 1