Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery

NCT03784638 | Completed

• 1 other identifier: KonyaNEU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the effects of lingually-based triangle flap design and buccally based triangular flap design on postoperative swelling, trismus pain after mandibular third molar surgery.

Conditions

Impacted Third Molar Tooth

Keywords

trismus; pain; edema; flap design

Outcome Measures

Primary Outcomes (1)

• For edema, the distances between Tragus-Pogonion, Tragus-Labial Commissure, Angulus Mandibula-Lateral Canthus will be measured preoperatively, postoperative 2nd day, 7th day and 14th day surgery.

  The edema measurement will be done preoperatively, postoperative 2nd day, 7th day and 14th day surgery.

  Up to 2 weeks

Secondary Outcomes (1)

• For the assesment of the pain, pain scale will be used.

  Up to 1 week

Study Arms (2)

lingually-based triangle flap design

EXPERIMENTAL

In the experimental group, an incision will be made adjacent to the distal surface of the mandibular second molar, and extended along the sulcus to the distobuccal corner of the mandibular second molar. An oblique vestibular incision will made and extended into the vestibular fornix of the mandible, aligned with the mesiobuccal cusp of the second molar. It was continued posterosuperiorly towards the anterior border of mandibular ramus. The lingually-based triangle flap design will be used.

Procedure: lingually-based triangle flap design

buccally based triangle flap design

PLACEBO COMPARATOR

In the control group, an incision will be made from the anterior border of the mandibular second molar. It will be extended along the sulcus to the distobuccal corner of the second molar crown. The incision will be continuous with vertical incision. The buccally based triangle flap design will be used.

Other: buccally based triangular flap design

Interventions

lingually-based triangle flap design PROCEDURE

A mucoperiosteal lingually-based triangle flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.

lingually-based triangle flap design

buccally based triangular flap design OTHER

A mucoperiosteal buccally based triangular flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.

buccally based triangle flap design

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• symmetrically positioned impacted bilateral mandibular third molars (mesioangular)

You may not qualify if:

• pericoronal pathology
• use of medications
• poor oral hygiene
• smoking habit
• pregnancy or lactation

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

Study Sites (1)

Necmettin Erbakan University, Faculty of Dentistry

Konya, Karatay, 42050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trismus; Pain; Edema

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Menziletoglu, DDS, PhD

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: lingually-based triangle flap design buccaly-based triangular flap design

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 24, 2018
• Study Start: November 30, 2018
• Primary Completion: March 11, 2019
• Study Completion: April 3, 2019
• Last Updated: April 8, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)