NCT05032989

Brief Summary

Mandibular 3rd molars are the most commonly impacted teeth in oral cavity followed by maxillary 3rd molars and maxillary canines respectively. Impaction is a condition where a tooth fails to erupt in its final functional position, theoretically owing to inadequate space distal to the second mandibular molar and the anterior border of the ascending ramus of the mandible . Surgical removal of the third molar is the most common procedure carried out by a maxillofacial surgeon in the dental office. Surgical extractions are time consuming, expensive and cause morbidities such as pain, swelling, dry socket, trismus, and nerve injury when compared to non-surgical extractions. Various classifications have been proposed for mandibular 3rd molars, most common of which, is based on angulation of impacted tooth to the long axis of 2nd molar. Distoangular impacted 3rd molars are very difficult to remove because of lack of space distal to the tooth and lack of interdental space available for the application of elevator. Cowhorn forcep engages between the bifurcation of the mandibular molars and below the bone crest and causes displacement of tooth by upward movement or by splitting mesial and distal root. In our study cowhorn forcep are fist placed between 2nd and 3rd molar below the cementoenamel junction after its placement an apical pressure in applied and this rotation results an upward and distal movement and displacement of impacted tooth from the socket which then can easily be removed with cow horn forcep or molar crown forcep. The aim of our study is to present the minimal invasive technique for the extraction of distoangular and vertical impacted mandibular 3rd molars using cow horn forcep in comparison to conventional surgical techniques to avoid complications associated with open surgical techniques . METHOD: Total 128 patients will be recruited and divided into 64 patients in each group (two groups) attending in Dr. inshrat ul ebad institute of oral health sciences, Ojha, fulfilling inclusion criteria and undergoing extraction of 3rd molars will be included in this study. The participant will be briefed about the nature and purpose of the study. They will be ensured that their information will be used for the study purpose only. Informed consent from the participants will be obtained. Complete history from the patients will be taken and pre-operative evaluation will be done by clinical (pain and swelling) and radiographical (angulation of the tooth) examination. All the patients would undergo extraction of 3rd molars via both either conventional surgical technique or the proposed technique in the study. Followup will be done after 3 days to evaluate the same post-operative variables (pain and swelling) after extraction of 3rd molar and both techniques will then be compared in terms of variables measured.

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
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 31, 2021

Last Update Submit

August 31, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Decrease post operative pain and swelling

    cownhorn forcep technique is used to reduce post operative pain and swelling

    3rd post operative day

Study Arms (2)

Extraction of distoangular and vertically positioned 3rd molar using cowhorn forcep

EXPERIMENTAL

Extraction with new technique

Procedure: Extraction of mandibular 3rd molar via Cowhorn forcep technique

Extraction of distoangular and vertically positioned 3rd molar via conventional method

ACTIVE COMPARATOR

Extraction with the conventional technique

Procedure: Extraction of mandibular 3rd molar via conventional technique

Interventions

Cowhorn forceps technique used to extract the tooth results in less post operative pain and swelling also it makes the extraction easier.

Extraction of distoangular and vertically positioned 3rd molar using cowhorn forcep

Conventional method of extraction uses dental elevator and forceps resulting in post operative pain and swellig.

Extraction of distoangular and vertically positioned 3rd molar via conventional method

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with bilateral distoangular and vertically positioned 3rd mandibular molars requiring extractions
  • Bilateral partially impacted or erupted mandibular 3rd molars
  • Both male and female patients
  • Teeth which can be extracted by Intra-alveolar method under local anaesthesia
  • Ages 18-35years

You may not qualify if:

  • Patients refusing to sign the informed consent
  • Patients that are medically compromised (systemic diseases)
  • Teeth having radiographically evident large periapical changes (abscess/granuloma/cyst)
  • Patients previously treated with radiotherapy or chemotherapy or both
  • Carious mandibular 2nd molar or missing 1st molar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Syed Wajid Hasan, BDS

    DUHS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Wajid Hasan, BDS

CONTACT

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
Postgraduate Trainee

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 2, 2021

Study Start

September 15, 2021

Primary Completion

February 28, 2022

Study Completion

June 1, 2022

Last Updated

September 2, 2021

Record last verified: 2021-08