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
About this trial
This is an interventional prevention trial for Pain, Postoperative
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
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
NCT ID
NCT05032989
First Posted
August 31, 2021
Last Updated
August 31, 2021
Sponsor
Dow University of Health Sciences
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
Learn more about this trial
Extraction of Distoangular and Vertically Positioned Mandibular 3rd Molars
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