NCT04875650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

April 28, 2021

Last Update Submit

May 3, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Physics Forceps

EXPERIMENTAL
Procedure: Extraction of Mandibular Molar using Physics Forceps

Conventional Forcep

OTHER
Procedure: Extraction of Mandibular Molar using Conventional Forceps

Interventions

Extraction of mandibular molars using physics forceps

Physics Forceps

Extraction of mandibular molars using conventional forceps

Conventional Forcep

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between 18-55 years
  • Mandibular molar teeth indicated for extractions with gingival index 1.

You may not qualify if:

  • Patients with uncontrolled systemic diseases, that compromise dental extraction
  • Mandibular 3rd Molars
  • Grade 2 and 3 mobile teeth
  • Grossly decayed mandibular molars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melaka Manipal Medical College

Malacca, 75150, Malaysia

Location

Study Officials

  • Auric Bhattacharya, BDS, MDS, FICOI, MFDS, RCPS

    Melaka Manipal Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 6, 2021

Study Start

December 2, 2020

Primary Completion

April 20, 2021

Study Completion

April 20, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations