- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04875650
Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars
May 3, 2021 updated by: Auric Bhattacharya, Melaka Manipal Medical College
Comparison of Physics Forceps and Conventional Forceps in Extraction of Mandibular Molars: A Double-Blinded Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Melaka, Malaysia, 75150
- Melaka Manipal Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physics Forceps
|
Extraction of mandibular molars using physics forceps
|
|
Other: Conventional Forcep
|
Extraction of mandibular molars using conventional forceps
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative Pain Score
Time Frame: Day 1
|
Use of a Visual Analogue Scale with 0 meaning no pain and 100 meaning severe pain
|
Day 1
|
|
Soft Tissue Healing Post Extraction
Time Frame: Day 3
|
Soft Tissue Healing Index by Landry et al.
|
Day 3
|
|
Patient Satisfaction
Time Frame: Day 1
|
4 point likert scale where 1 is very dissatisfied and 4 is very satisfied
|
Day 1
|
|
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
|
Day 1
|
|
Incidence of Alveolar Bone Fracture
Time Frame: Day 1
|
Fracture 1 and No fracture 0
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Auric Bhattacharya, BDS, MDS, FICOI, MFDS, RCPS, Melaka Manipal Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2020
Primary Completion (Actual)
April 20, 2021
Study Completion (Actual)
April 20, 2021
Study Registration Dates
First Submitted
April 28, 2021
First Submitted That Met QC Criteria
May 3, 2021
First Posted (Actual)
May 6, 2021
Study Record Updates
Last Update Posted (Actual)
May 6, 2021
Last Update Submitted That Met QC Criteria
May 3, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- MMMC/FOD/AR/B8/E C-2020 (01)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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