Clinical trial NCT04875650: Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars
Official title: Comparison of Physics Forceps and Conventional Forceps in Extraction of Mandibular Molars: A Double-Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Lead sponsor: Melaka Manipal Medical College
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Relative Pain Score
timeFrame: Day 1
measure: Soft Tissue Healing Post Extraction
timeFrame: Day 3
measure: Patient Satisfaction
timeFrame: Day 1
measure: Success of Extraction
timeFrame: Day 1
measure: Incidence of Alveolar Bone Fracture
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Melaka
country: Malaysia
facility: Melaka Manipal Medical College
Study officials:
affiliation: Melaka Manipal Medical College
name: Auric Bhattacharya, BDS, MDS, FICOI, MFDS, RCPS
role: PRINCIPAL_INVESTIGATOR
References: