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

Not Applicable

• Conditions: Soft Tissue Injuries
• Interventions: Procedure: Saurez Flap; Procedure: Triangular Flap; Procedure: Berwick Flap; Procedure: Heitz Flap

• Registration Number: NCT06266052
• Lead Sponsor: Recep Tayyip Erdogan University

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.

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 Timeline

• Study First Submitted: 2024-01-15
• Study Start: 2024-01-20
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-10
• Last Update Submitted: 2024-02-10
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-03-20
• Study Completion: 2024-04-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	Saurez Flap	Saurez flep design will be use in third molar impacted surgery
Group 1	Triangular Flap	triangular flep design will be use in third molar impacted surgery
Group 2	Berwick Flap	Berwick flep design will be use in third molar impacted surgery
Group 4	Heitz Flap	Heitz

Primary Outcome Measures

Name	Time	Method
Halitosis Amount	postoperative second and 7.th day	It will be evaluated as presence/absence of halitosis. 0/1
Eudema Amount	postoperative second and 7.th day	5 separate length measurements will be made on the face using a flexible ruler. (mm)
Pain Level	postoperative second and 7.th day	Pain values will be determined with vas scales numbered 0-10.
Trismus Level	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)
bone healing condition	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.

Trial Locations

Locations (1)

RTEU Faculty of Dentistry; 🇹🇷 Rize, Turkey