ClinicalTrials.gg
Enrolling by invitationNCT06266052Updated Feb 20, 2024

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

An interventional study of Triangular Flap and Berwick Flap in Soft Tissue Injuries, sponsored by Recep Tayyip Erdogan University. Enrolling by invitation at 1 site in Turkey. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Recep Tayyip Erdogan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Soft Tissue Injuries

Browse trials for

Keywords

  • third molar surgery
  • flap design
  • fractal analysis
  • soft tissue healing
03

In context

Soft Tissue Injuries

64 studies on the registry are indexed under Soft Tissue Injuries; 7 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 51 interventional studies indexed under Soft Tissue Injuries.

Browse Soft Tissue Injuries studies →

Lead sponsor

Recep Tayyip Erdogan University is the lead sponsor of 69 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria

  1. Pregancy
  2. Allergic conditions
  3. Diabetes
  4. Smokers
  5. Patients with low oral hygiene
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Group 1

    triangular flep design will be use in third molar impacted surgery

    Procedure: Triangular Flap

  • Experimental
    Group 2

    Berwick flep design will be use in third molar impacted surgery

    Procedure: Berwick Flap

  • Experimental
    Group 3

    Saurez flep design will be use in third molar impacted surgery

    Procedure: Saurez Flap

  • Experimental
    Group 4

    Heitz

    Procedure: Heitz Flap

Interventions

  • ProcedureTriangular 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.

  • ProcedureBerwick 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.

  • ProcedureSaurez 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.

  • ProcedureHeitz 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.

06

What researchers measure

Primary outcomes

  1. Eudema Amount

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

    Time frame: postoperative second and 7.th day

  2. Pain Level

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

    Time frame: postoperative second and 7.th day

  3. 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)

    Time frame: postoperative second and 7.th day

  4. Halitosis Amount

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

    Time frame: postoperative second and 7.th day

  5. 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.

    Time frame: preoperative and postoperative 3th month

07

Study locations

1 site
  • RTEU Faculty of Dentistry
    Rize, Turkey
08

References and documents

Individual participant data

Plan to share: No — no sharing permission

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06266052
Lead sponsor
Recep Tayyip Erdogan University
Responsible party
Zeynep Gumrukcu (Associate Professor, Recep Tayyip Erdogan University) — Principal investigator
First posted
Feb 20, 2024
Start date
Jan 20, 2024
Primary completion
Mar 20, 2024 (estimated)
Completion
Apr 20, 2024 (estimated)
Last update
Feb 20, 2024

Study contacts

zeynep gümrükçü, Dr
study director · PhD DDS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion