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Extraction of Distoangular and Vertically Positioned Mandibular 3rd Molars

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extraction of mandibular 3rd molar via Cowhorn forcep technique
Extraction of mandibular 3rd molar via conventional technique
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

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

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

    Arm Description

    Extraction with new technique

    Extraction with the conventional technique

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2021
    Last Updated
    August 31, 2021
    Sponsor
    Dow University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05032989
    Brief Title
    Extraction of Distoangular and Vertically Positioned Mandibular 3rd Molars
    Official Title
    Extraction of Distoangular and Vertically Positioned Mandibular 3rd Molars, A Comparative Study: Conventional Surgical Technique vs. Cowhorn Forceps Technique
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2021 (Anticipated)
    Primary Completion Date
    February 28, 2022 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dow University of Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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 . Objective: To compare the effectiveness of new technique using cow horn forcep with conventional surgical method among patients with vertical and distoangular lower third molar impactions requiring extraction. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Extraction of distoangular and vertically positioned 3rd molar using cowhorn forcep
    Arm Type
    Experimental
    Arm Description
    Extraction with new technique
    Arm Title
    Extraction of distoangular and vertically positioned 3rd molar via conventional method
    Arm Type
    Active Comparator
    Arm Description
    Extraction with the conventional technique
    Intervention Type
    Procedure
    Intervention Name(s)
    Extraction of mandibular 3rd molar via Cowhorn forcep technique
    Intervention Description
    Cowhorn forceps technique used to extract the tooth results in less post operative pain and swelling also it makes the extraction easier.
    Intervention Type
    Procedure
    Intervention Name(s)
    Extraction of mandibular 3rd molar via conventional technique
    Intervention Description
    Conventional method of extraction uses dental elevator and forceps resulting in post operative pain and swellig.
    Primary Outcome Measure Information:
    Title
    Decrease post operative pain and swelling
    Description
    cownhorn forcep technique is used to reduce post operative pain and swelling
    Time Frame
    3rd post operative day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Syed Wajid Hasan, BDS
    Phone
    03351350139
    Email
    syedwajidhasan@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Syed Wajid Hasan, BDS
    Organizational Affiliation
    DUHS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Extraction of Distoangular and Vertically Positioned Mandibular 3rd Molars

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