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

NCT06266052 | Enrolling By Invitation

• 1 other identifier: 2019/04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Soft Tissue Injuries

Keywords

third molar surgery; flap design; fractal analysis; soft tissue healing

Outcome Measures

Primary Outcomes (5)

• Eudema Amount

  5 separate length measurements will be made on the face using a flexible ruler. (mm)

  postoperative second and 7.th day

• Pain Level

  Pain values will be determined with vas scales numbered 0-10.

  postoperative second and 7.th day

• Trismus Level

  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

  It will be evaluated as presence/absence of halitosis. 0/1

  postoperative second and 7.th day

• bone healing condition

  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

Study Arms (4)

Group 1

EXPERIMENTAL

triangular flep design will be use in third molar impacted surgery

Procedure: Triangular Flap

Group 2

EXPERIMENTAL

Berwick flep design will be use in third molar impacted surgery

Procedure: Berwick Flap

Group 3

EXPERIMENTAL

Saurez flep design will be use in third molar impacted surgery

Procedure: Saurez Flap

Group 4

EXPERIMENTAL

Heitz

Procedure: Heitz Flap

Interventions

Triangular Flap PROCEDURE

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.

Group 1

Berwick Flap PROCEDURE

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.

Group 2

Saurez Flap PROCEDURE

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.

Group 3

Heitz Flap PROCEDURE

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.

Group 4

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Pregancy
• Allergic conditions
• Diabetes
• Smokers
• Patients with low oral hygiene

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

RTEU Faculty of Dentistry

Rize, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Soft Tissue Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• zeynep gümrükçü, Dr

  PhD DDS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 20, 2024
• Study Start: January 20, 2024
• Primary Completion: March 20, 2024
• Study Completion: April 20, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)