Physics Forceps vs Conventional Forceps in Extraction of... | NCT04875650

Studies
Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars

NCT04875650

Sponsor

Melaka Manipal Medical College

Status

Completed

Last Update Posted

May 6, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Tooth Extraction

Interventions

Extraction of Mandibular Molar using Physics Forceps
Extraction of Mandibular Molar using Conventional Forceps

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2020Actual

Primary Completion Date

Apr 20, 2021Actual

Completion Date

Apr 20, 2021Actual

First Submitted Date

Apr 28, 2021

First Submission Date that Met QC Criteria

May 3, 2021

First Posted Date

May 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2021

Last Update Posted Date

May 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Auric Bhattacharya, Principal Investigator, Associate Professor, Melaka Manipal Medical CollegePrincipal Investigator

Lead Sponsor

Melaka Manipal Medical CollegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physics Forceps	Experimental		Procedure: Extraction of Mandibular Molar using Physics Forceps
Conventional Forcep	Other		Procedure: Extraction of Mandibular Molar using Conventional Forceps

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extraction of Mandibular Molar using Physics Forceps	Procedure	Extraction of mandibular molars using physics forceps	Physics Forceps

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Auric Bhattacharya, BDS, MDS, FICOI, MFDS, RCPS	Melaka Manipal Medical College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Melaka Manipal Medical College		Malacca		75150	Malaysia