NCT05143359

Brief Summary

Accuracy of the variables used in Wharfe assessment and Pederson difficulty index for impacted mandibular third molar surgery. The lower 3rd molar tooth is one of the most frequently impacted teeth. Its prevalence ranges from 30.3% to 68.6% worldwide according to a study conducted by Sekhar, 2020. The impaction of a tooth can be defined as a pathological condition in which eruption of tooth is not normal i.e. it is not erupted as expected within a specific time period. The impaction renders the affected tooth as non-functional due to its postural instability/ abnormal position. The normal tooth eruption is dependent on several local as well as systemic factors. Normal eruption can be altered by neighboring tooth, excessive soft tissue in the surrounding, or the dense overlying bone. Race and Ethnicity an also affect/ alter the impaction rate. The removal of 3rd mandibular molar/ wisdom tooth is one of the most commonly performed surgical procedures, being done in dental clinics on daily basis. To predict the difficulty level of this procedure for impacted lower 3rd molar, no scoring system/ scale is considered sufficient i.e. every scale takes some factors into account, while missing some factors, so clinically not very much reliable. Some of the proposed scales/ models which are clinically in use are as follows: WHARFE's, Pederson's, Winter's, and Pell and Gregory's model.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

October 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

October 16, 2021

Last Update Submit

November 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Extraction of mandibular 3rd molar

    Difficulty of extraction will be assessed by difficulty index

    Extraction of mandibular 3rd molar assessment by Wharfe and Peterson's index immediately after the intervention/procedure/surgery

  • Extraction of mandibular 3rd molar

    Difficulty of extraction will be assessed by difficulty index

    Extraction of mandibular 3rd molar assessment by winters immediately after the intervention/procedure/surgery

Study Arms (2)

Wharfe and Pederson difficulty index

EXPERIMENTAL

Assessment of Difficulty in third molar extraction using Wharfe and Pederson difficulty index

Diagnostic Test: Wharfe and Pederson difficulty index

Winters difficulty index

ACTIVE COMPARATOR

Assessment of Difficulty in third molar extraction using Winters difficulty index

Diagnostic Test: Winters difficulty index

Interventions

Efficiency of Wharfe and Pederson Difficulty index in extraction of third molars.

Wharfe and Pederson difficulty index

Efficiency of Winters Difficulty index in extraction of third molars.

Winters difficulty index

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 18 to 60 years with either gender
  • Patients having impacted 3rd mandibular molar according to Winter's classification (as per operational definition)
  • Patients with no evidence of dental caries or restoration in the past

You may not qualify if:

  • Patients with history of orthodontic treatment or periodontal surgery
  • Patients having craniofacial anomalies, congenital deformities or syndromes
  • Patients with evidence of cyst or tumor in the molar area
  • Not willing to participate in my study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Gobind Ram

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Accuracy of variables for Wharfe assessment and Pederson difficulty index for impacted mandiblar third molar surgery---A prospective clinical study

Study Record Dates

First Submitted

October 16, 2021

First Posted

December 3, 2021

Study Start

November 30, 2021

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

December 3, 2021

Record last verified: 2021-11