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

Sponsor
Konya Necmettin Erbakan Üniversitesi (Other)
Overall Status
Completed
CT.gov ID
NCT03784638
Collaborator
(none)
30
1
2
4.1
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: lingually-based triangle flap design
  • Other: buccally based triangular flap design
N/A

Detailed Description

Investigators planned a prospective and split mouth study. Thirty patients is randomly selected. Inclusion criteria is being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy. Exclusion criteria is as follows: Alcohol abuse, smoking, pregnancy and acute severe periodontitis.

All surgeries will be carried out by the same surgeon. For each patient, the impacted teeth will be extracted in two sessions using the two different flap design.One side of the patients was selected and labeled as "experimental group". In this group, investigators will use lingually-based triangle flap design while investigators extract the impacted third molar teeth. Other side was accepted as "control group" and in this group, investigators will use buccally based triangular flap design.

In the experimental group, an incision was 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 was 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. 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.

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

After the surgery, the patients will be prescribed a 5-day course of 100 mg flurbiprofen twice daily, 1 gr amoxicillin twice daily and chlorhexidine gluconate- benzydamine hydrochloride antiseptic mouthwash every 8 h.There will be at least one month between two surgeries.

The duration of each procedure from the start of the incision to the time of last suture placement will be noted.

Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth opening, wound dehiscence. For the assesment of the pain, pain scale will be used. For the swelling evaluation, measurement will be done from the different three region on the face.

  • Tragus-Pogonion

  • Tragus-Labial Commissura

  • Angulus Mandible-Lateral canthus

Maximum mouth opening will be noted before and after (one week later) the surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
lingually-based triangle flap design buccaly-based triangular flap designlingually-based triangle flap design buccaly-based triangular flap design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery
Actual Study Start Date :
Nov 30, 2018
Actual Primary Completion Date :
Mar 11, 2019
Actual Study Completion Date :
Apr 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: lingually-based triangle flap design

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
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.

Placebo Comparator: buccally based triangle flap design

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
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.

Outcome Measures

Primary Outcome Measures

  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. [Up to 2 weeks]

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

Secondary Outcome Measures

  1. For the assesment of the pain, pain scale will be used. [Up to 1 week]

    The patients will fill the pain scale every day until the seventh day after operation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • symmetrically positioned impacted bilateral mandibular third molars (mesioangular)
Exclusion Criteria:
  • pericoronal pathology

  • use of medications

  • poor oral hygiene

  • smoking habit

  • pregnancy or lactation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Necmettin Erbakan University, Faculty of Dentistry Konya Karatay Turkey 42050

Sponsors and Collaborators

  • Konya Necmettin Erbakan Üniversitesi

Investigators

  • Principal Investigator: Dilek Menziletoglu, DDS, PhD, Necmettin Erbakan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dilek Menziletoglu, Principal Investigator, Konya Necmettin Erbakan Üniversitesi
ClinicalTrials.gov Identifier:
NCT03784638
Other Study ID Numbers:
  • KonyaNEU
First Posted:
Dec 24, 2018
Last Update Posted:
Apr 8, 2019
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dilek Menziletoglu, Principal Investigator, Konya Necmettin Erbakan Üniversitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2019