Soft Tissue InjuriesNCT06266052
Evaluation of the Effects of Four Different Flap Designs on Tissue Healing in Lower Third Molar Surgery
A study testing Triangular Flap, Berwick Flap and Saurez Flap in people with Soft Tissue Injuries, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- Triangular Flap, Berwick Flap and Saurez Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2024to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18-45
- Do not have a systemic disease that prevents tissue healing
- Patients needed impacted third surgery
Who cannot join
- Pregancy
- Allergic conditions
- Diabetes
- Smokers
- Patients with low oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Soft Tissue Injuries
- Being tested
- Triangular Flap, Berwick Flap, Saurez Flap, Heitz Flap
- Keywords
- third molar surgery, flap design, fractal analysis, soft tissue healing
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triangular FlapProcedure or surgery
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.
Berwick FlapProcedure or surgery
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.
Saurez FlapProcedure or surgery
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.
Heitz FlapProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | triangular flep design will be use in third molar impacted surgery Receives: Procedure: Triangular Flap |
| Group 2 | Experimental | Berwick flep design will be use in third molar impacted surgery Receives: Procedure: Berwick Flap |
| Group 3 | Experimental | Saurez flep design will be use in third molar impacted surgery Receives: Procedure: Saurez Flap |
| Group 4 | Experimental | Heitz Receives: Procedure: Heitz Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eudema Amount
5 separate length measurements will be made on the face using a flexible ruler. (mm)
Measured: postoperative second and 7.th day
Pain Level
Pain values will be determined with vas scales numbered 0-10.
Measured: 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)
Measured: postoperative second and 7.th day
Halitosis Amount
It will be evaluated as presence/absence of halitosis. 0/1
Measured: 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.
Measured: preoperative and postoperative 3th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Jan 2024
- Primary completion20 Mar 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Gumrukcu, Recep Tayyip Erdogan University
- Investigators
- zeynep gümrükçü, Dr, Study director, PhD DDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266052
- Sponsor's protocol ID
- 2019/04
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing permission
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects of Four Different Flap Designs on Healing Lower Third Molar Surgery
- ClinicalTrials.gov ID
- NCT06266052
- Acronym / sponsor ID
- 2019/04
- Conditions
- Soft Tissue Injuries
- Keywords
- third molar surgery, flap design, fractal analysis, soft tissue healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Triangular Flaptriangular flep design will be use in third molar impacted surgery |
| Group 2 | Experimental | Procedure: Berwick FlapBerwick flep design will be use in third molar impacted surgery |
| Group 3 | Experimental | Procedure: Saurez FlapSaurez flep design will be use in third molar impacted surgery |
| Group 4 | Experimental | Procedure: Heitz FlapHeitz |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged between 18-45
- Do not have a systemic disease that prevents tissue healing
- Patients needed impacted third surgery
Key exclusion criteria (5 listed)
- Pregancy
- Allergic conditions
- Diabetes
- Smokers
- Patients with low oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triangular FlapTriangular 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. | Procedure or surgery | Group 1 |
| Berwick FlapBerwick 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. | Procedure or surgery | Group 2 |
| Saurez FlapIn 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. | Procedure or surgery | Group 3 |
| Heitz FlapHeitz 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. | Procedure or surgery | Group 4 |
Primary outcome
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)
Pain Level
Time frame: postoperative second and 7.th day
Pain values will be determined with vas scales numbered 0-10.
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)
Halitosis Amount
Time frame: postoperative second and 7.th day
It will be evaluated as presence/absence of halitosis. 0/1
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No. no sharing permission
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zeynep gümrükçü, Dr study director
PhD DDS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triangular Flap, Berwick Flap and Saurez Flap in people with Soft Tissue Injuries, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eudema Amount (time frame: postoperative second and 7.th day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.