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

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
lingually-based triangle flap design
buccally based triangular flap design
Sponsored by
Konya Necmettin Erbakan Üniversitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring trismus, pain, edema, flap design

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Necmettin Erbakan University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lingually-based triangle flap design

buccally based triangle flap design

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

For the assesment of the pain, pain scale will be used.
The patients will fill the pain scale every day until the seventh day after operation.

Full Information

First Posted
December 14, 2018
Last Updated
April 4, 2019
Sponsor
Konya Necmettin Erbakan Üniversitesi
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1. Study Identification

Unique Protocol Identification Number
NCT03784638
Brief Title
Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery
Official Title
Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
March 11, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Necmettin Erbakan Üniversitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
trismus, pain, edema, flap design

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
lingually-based triangle flap design buccaly-based triangular flap design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lingually-based triangle flap design
Arm Type
Experimental
Arm Description
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.
Arm Title
buccally based triangle flap design
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
lingually-based triangle flap design
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
buccally based triangular flap design
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
The edema measurement will be done preoperatively, postoperative 2nd day, 7th day and 14th day surgery.
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
For the assesment of the pain, pain scale will be used.
Description
The patients will fill the pain scale every day until the seventh day after operation.
Time Frame
Up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Menziletoglu, DDS, PhD
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necmettin Erbakan University, Faculty of Dentistry
City
Konya
State/Province
Karatay
ZIP/Postal Code
42050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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