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

NCT05385679 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-06-13

No results posted yet for this study

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

Interventions

PROCEDURE

Surgical Extraction of lower third molar

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.

Sponsors & Collaborators

  • Ashutosh Kumar Singh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-03-02
Completion
2023-03-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385679 on ClinicalTrials.gov