Evaluation of the Effects of Four Different Flap Designs on Tissue Healing in Lower Third Molar Surgery

February 10, 2024 updated by: Zeynep Gumrukcu, Recep Tayyip Erdogan University

the Effects of Four Different Flap Designs on Healing Lower Third Molar Surgery

The aim of this study is to prospectively evaluate the effectiveness of 4 different flap types used during mandibular impacted wisdom teeth surgery on postoperative quality of life, soft tissue and hard tissue healing at the end of the 3rd month.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomly included in 4 groups with 4 different incision types planned among the patients who will apply for impacted third molar tooth extraction, and each group will consist of 25 patients. Triangular flap will be applied to the patients in Group 1, Berwick incision will be applied in Group 2, Suarez incision will be applied in Group 3, and Heitz incision will be applied in Group 4.The operation time will be recorded on the form. The operation time will be evaluated as the period from anesthesia to the last suture. The patient will be called for control on the 2nd and 7th days after the operation. During control periods, pain value will be recorded using a VAS scale numbered between 0 and 10. Parameter data such as trismus, edema, halitosis, color of the healing tissue, presence/type of granulation will be recorded on the forms created during the control periods, and the patients' sutures will be removed on the 7th control day, as is done in impacted third molar surgery. Patients will be called for a check-up at the end of 3 months to detect hard tissue healing, and a panoramic radiography will be taken to check hard tissue healing. Using the patient's 3rd month follow-up x-rays, fractal analysis will be performed in the area to evaluate the quality of the newly formed bone in the extracted tooth area.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Rize, Turkey
        • RTEU Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients aged between 18-45
  2. Do not have a systemic disease that prevents tissue healing
  3. Patients needed impacted third surgery

Exclusion Criteria

  1. Pregancy
  2. Allergic conditions
  3. Diabetes
  4. Smokers
  5. Patients with low oral hygiene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
triangular flep design will be use in third molar impacted surgery
Procedure: Triangular Flap
Triangular flap is a type of flap that is made in the retromolar region, from the distal of the 2nd molar tooth towards the ramus and up to the distal gingival sulcus of the 2nd molar, and includes a vertical releasing incision added from the distobuccal sulcus of the 2nd molar tooth. The auxiliary vertical incision made in this flap type allows the wound to be closed without tension.
Experimental: Group 2
Berwick flep design will be use in third molar impacted surgery
Procedure: Berwick Flap
Berwick described a type of flap whose base is in the distolingual direction of the second molar tooth, in which the tongue-shaped vestibular wing extends to the buccal part of the mandible. In this modification, the incision line is not over the bone defect created by the extraction.
Experimental: Group 3
Saurez flep design will be use in third molar impacted surgery
Procedure: Saurez Flap
In the modified flap type he used, Suarez combined the crestal incision (marginal incision) from the distobuccal corner of the second molar tooth, following the line where the retromolar area meets the buccal bone, with a releasing incision made at the mesial and distal ends of the incision.
Experimental: Group 4
Heitz
Procedure: Heitz Flap
Heitz used the incision line extending from the distobuccal corner of the 2nd molar tooth to the buccal face of the 2nd molar tooth and downwards, by rotating it towards the angulus mandible on the buccal bone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eudema Amount
Time Frame: postoperative second and 7.th day
5 separate length measurements will be made on the face using a flexible ruler. (mm)
postoperative second and 7.th day
Pain Level
Time Frame: postoperative second and 7.th day
Pain values will be determined with vas scales numbered 0-10.
postoperative second and 7.th day
Trismus Level
Time Frame: postoperative second and 7.th day
the distance between the incisal edges of the lower and upper teeth during maximum mouth opening will be measured in millimeters with a ruler. (mm)
postoperative second and 7.th day
Halitosis Amount
Time Frame: postoperative second and 7.th day
It will be evaluated as presence/absence of halitosis. 0/1
postoperative second and 7.th day
bone healing condition
Time Frame: preoperative and postoperative 3th month
With the help of a program, the amount of trabeculae in the bone will be counted by the box counting method and a numerical value will be obtained.
preoperative and postoperative 3th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University

Investigators

  • Study Director: zeynep gümrükçü, Dr, PhD DDS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2024

Primary Completion (Estimated)

March 20, 2024

Study Completion (Estimated)

April 20, 2024

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

February 10, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no sharing permission

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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