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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05032989
Other study ID # wajid001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 15, 2021
Est. completion date June 2022

Study information

Verified date August 2021
Source Dow University of Health Sciences
Contact Syed Wajid Hasan, BDS
Phone 03351350139
Email syedwajidhasan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 128
Est. completion date June 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Extraction of mandibular 3rd molar via Cowhorn forcep technique
Cowhorn forceps technique used to extract the tooth results in less post operative pain and swelling also it makes the extraction easier.
Extraction of mandibular 3rd molar via conventional technique
Conventional method of extraction uses dental elevator and forceps resulting in post operative pain and swellig.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease post operative pain and swelling cownhorn forcep technique is used to reduce post operative pain and swelling 3rd post operative day
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