Comparison of Two Flaps in Surgical Removal of Impacted Lower Third Molar

NCT05385679 | Unknown DMC

• 1 other identifier: IOM2
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Project summary The surgical removal of mandibular third molar is one of the most common procedures done in oral and maxillofacial surgery. Patients often experience pain, swelling, trismus, dehiscence, alveolar osteitis, infection, nerve injury and periodontal tissue damage after third molar surgery. Flap design is an important step in third molar surgery.The aim of this study is to compare the triangular and envelope flap designs in lower third molar surgery in terms of postoperative sequelae including pain ,trismus,swelling,incidence of dry socket and also operative time taken.The study also aims to find out does the level of impacted mandibular third molar and number of roots has effect on postoperative outcomes in surgical removal of mandibular third molar.The study design used will be a double-blind randomized clinical study. Patients who fit the inclusion criteria will be included as research subjects.Sample will be divided into two groups randomly. In one group the envelope flap will be raised during surgical removal of the lower third molar while in the other triangular flap will be used. Investigators will also divide the third molars into level 1,level 2,level 3 based on the relationship between the tip of mesial cusp of impacted third molar and the distal surface of crown of adjacent second molar based on orthopantomograph findings.Level 1 will be when the tip of mesial cusp of third molar is within the occlusal third of crown of second molar,level 2 will be when the tip of mesial cusp of third molar is within the middle third of crown of second molar, level 3 will be when the tip of mesial cusp of third molar is within and below the cervical third of crown of second molar. Another subgroup will be based on the number of roots of the impacted third molar where investigators will divide the third molar into single rooted and multirooted based on orthopantomograph findings. Investigators will also divide the sample based on gender and age group as below 30 years and above 30 years. The primary outcomes to be measured are pain and operative time while secondary outcomes are swelling ,trismus and incidence of dry socket.Outcome assessment will be done by another clinician than surgeon using scientific tools and techniques as mentioned. Surgical procedures and outcomes measurement will be done by separate clinicians to ensure masking.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (4)

• operative time taken for the surgical removal of impacted lower third molar

  The operative time taken will be recorded from the point of incision to the point of last suturing in terms of minutes.

  immediately after surgery

• postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days

  The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.

  1st postoperative day

• postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days

  The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.

  3rd postoperative day

• postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days

  The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.

  7th postoperative day

Secondary Outcomes (8)

• postoperative swelling

  1st postoperative day

• postoperative swelling

  3rd postoperative day

• postoperative swelling

  7th postoperative day

• post operative trismus

  1st postoperative day

• post operative trismus

  3rd postoperative day

Study Arms (2)

Envelop Flap

ACTIVE COMPARATOR

An envelope flap designs involves a sulcular incision from the first to the second molar and a distal relieving incision to the mandibular ramus.

Procedure: Surgical Extraction of lower third molar

Triangular flap

ACTIVE COMPARATOR

Triangular flap involves incision from the mandibular ramus to the distobuccal crown edge of the second molar, followed by a perpendicular incision obliquely into the mandibular vestibulum, with a length of about 10 mm.

Procedure: Surgical Extraction of lower third molar

Interventions

Surgical Extraction of lower third molar PROCEDURE

The surgical removal of mandibular third molar is one of the most common procedures done in oral and maxillofacial surgery. Patients often experience pain, swelling, trismus, dehiscence, alveolar osteitis, infection, nerve injury and periodontal tissue damage after third molar surgery. Flap design is an important step in third molar surgery. Envelope flap and modifications of triangular flap are the two most commonly used flaps in surgical removal of lower third molar.

Envelop Flap; Triangular flap

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-50 years
• No systemic illness and not taking any regular medications
• No signs of local inflammation
• Mesioangular and vertically impacted lower third molar
• Not under antibiotics for at least 3 days before surgery

You may not qualify if:

• With known systemic illness
• Those taking regular medications
• Presenting with pain and swelling at the time of surgery
• Impactions other than mesioangular and vertical impactions of lower third molar
• Under antibiotics within 3 days of surgical procedure
• Those having habit of cigarette smoking and females taking oral contraceptives

Sponsors & Collaborators

• Ashutosh Kumar Singh: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of department Oral And Maxillofacial Surgery

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 23, 2022
• Study Start: June 1, 2022
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: June 13, 2022

Record last verified: 2022-06