Surgical FlapsNCT07758192
Oral Flap Outline and Local Blood Supply After Surgical Removal of Lower Third Molar Teeth
A study testing Sulcular flap elevation for wisdom tooth removal and Three-cornered flap elevation for wisdom tooth removal in people with Surgical Flaps and Oral Surgical Procedures, run by Betül Taş Özyurtseven at 1 site in Turkey (Türkiye).
Trial summary
Wisdom teeth in the lower jaw are frequently buried in bone and must be taken out surgically. To reach the tooth, the surgeon lifts the gum away from the bone as a flap, and the shape of that flap is left to the surgeon's judgement. Two outlines are in everyday use. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Surgical Flaps, Oral Surgical Procedures, Regional Blood Flow
- What is being tested?
- Sulcular flap elevation for wisdom tooth removal and Three-cornered flap elevation for wisdom tooth removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Nov 2020to 9 Nov 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Free of systemic illness and taking no regular medication
- Aged 18 to 40 years
- One fully bone-impacted mandibular wisdom tooth for which surgical removal is indicated
- Ramus relationship of class II or III and depth position A, B or C on the Pell and Gregory scheme
- Angulation falling into one of four categories on Winter's scheme: vertical, mesioangular, horizontal or distoangular
- Neighbouring second molar intact, i.e. without extensive caries, endodontic treatment, a large filling or a crown
- Willing and able to give written consent and to attend both follow-up visits
Who cannot join
- Any systemic disorder, or use of medication on a continuing basis
- Tobacco use
- Previous irradiation or chemotherapy involving the head and neck
- Infection within the mouth at the time of surgery, including acute pericoronitis
- Pregnancy or suspected pregnancy
- Menstruation at the time of a scheduled measurement
- Need for more than two anaesthetic cartridges to achieve profound anaesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Gaziantep, Gaziantep, 27310
About this study
Official title: Influence of Two Mucoperiosteal Flap Outlines on Neighbouring-Tooth and Mucosal Microcirculation Following Surgical Removal of Impacted Mandibular Wisdom Teeth: A Laser Doppler Flowmetry Investigation
Wisdom teeth in the lower jaw are frequently buried in bone and must be taken out surgically. To reach the tooth, the surgeon lifts the gum away from the bone as a flap, and the shape of that flap is left to the surgeon's judgement. Two outlines are in everyday use. The first runs only along the necks of the teeth, so the gum is lifted without any additional cut. The second adds a short downward cut in front, which opens the field more widely but also divides some of the small vessels that run within the gum.
Because the tissues around a wound rely on a rich network of tiny vessels while they repair themselves, it is worth knowing whether these two outlines leave the local circulation in a different state. This project measured that circulation directly. A laser probe was placed against the tooth in front of the extraction site and against three points on the cheek-side gum, and the amount of moving blood beneath the probe was recorded. To make sure the probe returned to exactly the same spots at every visit, a thin clear plastic guide with prepared openings was made for each participant from a plaster model of the mouth.
Measurements were taken before the operation and again on the third and the seventh day afterwards. Facial swelling and how widely the mouth could be opened were recorded on the same occasions. Participants were assigned to one of the two flap outlines in turn, and every operation was carried out by the same surgeon so that the comparison depended on the flap outline alone.
Read the detailed description
Fifty-six systemically healthy adults presenting for surgical removal of a single fully bone-impacted mandibular wisdom tooth were assigned to one of two mucoperiosteal flap outlines by an alternating (non-random) sequence, giving twenty-eight participants per arm. Assignment was stratified by angulation according to Winter's scheme, so that each of the four angulation categories contributed seven cases to each arm.
Microvascular perfusion was quantified in perfusion units using a laser Doppler flowmeter (Perimed, Järfälla, Sweden). One recording site lay on the mid-buccal aspect of the tooth immediately anterior to the extraction site, at the crossing of its mesiodistal and occlusocervical axes, and served as an index of pulp circulation; three further sites were distributed over the adjacent buccal mucosa. Probe position was reproduced across visits by a 2 mm transparent acrylic stent carrying prepared probe housings, constructed individually on a stone model. Each site was sampled for 30 seconds.
Swelling was derived from three facial reference distances (gonion to labial commissure, tragus to labial commissure, and gonion to lateral canthus), averaged to a single value. Mouth opening was taken as the greatest interincisal distance. Every assessment was carried out immediately before surgery and repeated on the third and seventh postoperative days, sutures being removed at the final visit.
All operations were performed by one operator with a standard armamentarium under inferior alveolar, lingual and buccal block anaesthesia, using no more than two cartridges of articaine 40 mg/mL with epinephrine 1:100,000. Bone was removed and the tooth divided with a physiodispenser and steel burs under saline cooling, and the socket was closed with 3/0 silk. All participants received amoxicillin-clavulanate, paracetamol and a benzydamine-chlorhexidine mouthrinse after the procedure. Group means were compared by repeated-measures analysis of variance with Tukey HSD pairwise testing.
- Conditions
- Surgical Flaps, Oral Surgical Procedures, Regional Blood Flow, Tooth, Impacted, Molar, Third
- Being tested
- Sulcular flap elevation for wisdom tooth removal, Three-cornered flap elevation for wisdom tooth removal
- Keywords
- mouth opening, swelling, mucosal perfusion, pulp circulation, laser Doppler flowmetry, vertical releasing incision, mucoperiosteal flap, impacted wisdom tooth
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulcular flap elevation for wisdom tooth removalProcedure or surgery
Also called Intervention 1
The mucoperiosteum is raised through an incision confined to the gingival sulcus, carried from the mesial aspect of the first molar back to the distal aspect of the second molar and then along the external oblique ridge.
Three-cornered flap elevation for wisdom tooth removalProcedure or surgery
The same sulcular and posterior incision is used, with the addition of a vertical relieving cut placed anterior to the second molar and kept clear of the interdental papilla
| Study group | Role | What they receive |
|---|---|---|
| Sulcular (envelope) flap | Active comparator | The mucoperiosteum is raised through an incision confined to the gingival sulcus, carried from the mesial aspect of the first molar back to the distal aspect of the second molar and then along the external oblique ridge. No vertical cut is made. Receives: Procedure: Sulcular flap elevation for wisdom tooth removal |
| Three-cornered (trapezoidal) flap | Active comparator | The same sulcular and posterior incision is used, with the addition of a vertical relieving cut placed anterior to the second molar and kept clear of the interdental papilla. Receives: Procedure: Three-cornered flap elevation for wisdom tooth removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mucosal microcirculation adjacent to the operative field
Perfusion in perfusion units (PU) at three buccal mucosal sites recorded by laser Doppler flowmetry through the same stabilising stent, 30 seconds per site. The most anterior site lies in the region traversed by the vertical relieving cut of the three-cornered outline.
Measured: Immediately before surgery, and on postoperative days 3 and 7
Change in pulp microcirculation of the tooth adjacent to the extraction site
Perfusion recorded in perfusion units (PU) by laser Doppler flowmetry over the mid-buccal aspect of the neighbouring second molar, with probe position reproduced by an individually made acrylic stent. Each recording lasts 30 seconds. A higher value indicates greater circulation.
Measured: Immediately before surgery, and on postoperative days 3 and 7
Secondary outcomes (3)
Change in facial swelling
Mean of three facial reference distances measured in centimetres: gonion to labial commissure, tragus to labial commissure, and gonion to lateral canthus. A higher value indicates more swelling.
Measured: Immediately before surgery, and on postoperative days 3 and 7
Change in maximum mouth opening
Greatest interincisal distance in millimetres, used as an index of restricted opening. A lower value indicates greater restriction.
Measured: Immediately before surgery, and on postoperative days 3 and 7
Duration of the operation
Elapsed time in minutes from the first cut to placement of the final suture.
Measured: Day of surgery (day 0), intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start9 Nov 2020
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical FlapsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betül Taş Özyurtseven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Betül Taş Özyurtseven, University of Gaziantep
- Investigators
- Betül Taş Özyurtseven, DDS, PhD, Assoc. Prof. Dr., Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758192
- Sponsor's protocol ID
- 2020/284
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: available from the corresponding author on reasonable request
Publications
Kirk DG, Liston PN, Tong DC, Love RM. Influence of two different flap designs on incidence of pain, swelling, trismus, and alveolar osteitis in the week following third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jul;104(1):e1-6. doi: 10.1016/j.tripleo.2007.01.032. Epub 2007 May 15.
PubMed 17507264
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Two Mucoperiosteal Flap Outlines on Neighbouring-Tooth and Mucosal Microcirculation Following Surgical Removal of Impacted Mandibular Wisdom Teeth: A Laser Doppler Flowmetry Investigation
- ClinicalTrials.gov ID
- NCT07758192
- Acronym / sponsor ID
- 2020/284
- Conditions
- Surgical Flaps, Oral Surgical Procedures, Regional Blood Flow, Tooth, Impacted, Molar, Third
- Keywords
- mouth opening, swelling, mucosal perfusion, pulp circulation, laser Doppler flowmetry, vertical releasing incision, mucoperiosteal flap, impacted wisdom tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Betül Taş ÖzyurtsevenUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 11 Aug 2026 (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.
Wisdom teeth in the lower jaw are frequently buried in bone and must be taken out surgically. To reach the tooth, the surgeon lifts the gum away from the bone as a flap, and the shape of that flap is left to the surgeon's judgement. Two outlines are in everyday use. The first runs only along the necks of the teeth, so the gum is lifted without any additional cut. The second adds a short downward cut in front, which opens the field more widely but also divides some of the small vessels that run within the gum.
Because the tissues around a wound rely on a rich network of tiny vessels while they repair themselves, it is worth knowing whether these two outlines leave the local circulation in a different state. This project measured that circulation directly. A laser probe was placed against the tooth in front of the extraction site and against three points on the cheek-side gum, and the amount of moving blood beneath the probe was recorded. To make sure the probe returned to exactly the same spots at every visit, a thin clear plastic guide with prepared openings was made for each participant from a plaster model of the mouth.
Measurements were taken before the operation and again on the third and the seventh day afterwards. Facial swelling and how widely the mouth could be opened were recorded on the same occasions. Participants were assigned to one of the two flap outlines in turn, and every operation was carried out by the same surgeon so that the comparison depended on the flap outline alone.
Detailed description
Fifty-six systemically healthy adults presenting for surgical removal of a single fully bone-impacted mandibular wisdom tooth were assigned to one of two mucoperiosteal flap outlines by an alternating (non-random) sequence, giving twenty-eight participants per arm. Assignment was stratified by angulation according to Winter's scheme, so that each of the four angulation categories contributed seven cases to each arm.
Microvascular perfusion was quantified in perfusion units using a laser Doppler flowmeter (Perimed, Järfälla, Sweden). One recording site lay on the mid-buccal aspect of the tooth immediately anterior to the extraction site, at the crossing of its mesiodistal and occlusocervical axes, and served as an index of pulp circulation; three further sites were distributed over the adjacent buccal mucosa. Probe position was reproduced across visits by a 2 mm transparent acrylic stent carrying prepared probe housings, constructed individually on a stone model. Each site was sampled for 30 seconds.
Swelling was derived from three facial reference distances (gonion to labial commissure, tragus to labial commissure, and gonion to lateral canthus), averaged to a single value. Mouth opening was taken as the greatest interincisal distance. Every assessment was carried out immediately before surgery and repeated on the third and seventh postoperative days, sutures being removed at the final visit.
All operations were performed by one operator with a standard armamentarium under inferior alveolar, lingual and buccal block anaesthesia, using no more than two cartridges of articaine 40 mg/mL with epinephrine 1:100,000. Bone was removed and the tooth divided with a physiodispenser and steel burs under saline cooling, and the socket was closed with 3/0 silk. All participants received amoxicillin-clavulanate, paracetamol and a benzydamine-chlorhexidine mouthrinse after the procedure. Group means were compared by repeated-measures analysis of variance with Tukey HSD pairwise testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulcular (envelope) flap | Active comparator | Procedure: Sulcular flap elevation for wisdom tooth removalThe mucoperiosteum is raised through an incision confined to the gingival sulcus, carried from the mesial aspect of the first molar back to the distal aspect of the second molar and then along the external oblique ridge. No vertical cut is made. |
| Three-cornered (trapezoidal) flap | Active comparator | Procedure: Three-cornered flap elevation for wisdom tooth removalThe same sulcular and posterior incision is used, with the addition of a vertical relieving cut placed anterior to the second molar and kept clear of the interdental papilla. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Free of systemic illness and taking no regular medication
- Aged 18 to 40 years
- One fully bone-impacted mandibular wisdom tooth for which surgical removal is indicated
- Ramus relationship of class II or III and depth position A, B or C on the Pell and Gregory scheme
- Angulation falling into one of four categories on Winter's scheme: vertical, mesioangular, horizontal or distoangular
Key exclusion criteria (7 listed)
- Any systemic disorder, or use of medication on a continuing basis
- Tobacco use
- Previous irradiation or chemotherapy involving the head and neck
- Infection within the mouth at the time of surgery, including acute pericoronitis
- Pregnancy or suspected pregnancy
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 |
|---|---|---|
| Sulcular flap elevation for wisdom tooth removalAlso: Intervention 1The mucoperiosteum is raised through an incision confined to the gingival sulcus, carried from the mesial aspect of the first molar back to the distal aspect of the second molar and then along the external oblique ridge. | Procedure or surgery | Sulcular (envelope) flap |
| Three-cornered flap elevation for wisdom tooth removalThe same sulcular and posterior incision is used, with the addition of a vertical relieving cut placed anterior to the second molar and kept clear of the interdental papilla | Procedure or surgery | Three-cornered (trapezoidal) flap |
Primary outcome
Change in mucosal microcirculation adjacent to the operative field
Time frame: Immediately before surgery, and on postoperative days 3 and 7
Perfusion in perfusion units (PU) at three buccal mucosal sites recorded by laser Doppler flowmetry through the same stabilising stent, 30 seconds per site. The most anterior site lies in the region traversed by the vertical relieving cut of the three-cornered outline.
Change in pulp microcirculation of the tooth adjacent to the extraction site
Time frame: Immediately before surgery, and on postoperative days 3 and 7
Perfusion recorded in perfusion units (PU) by laser Doppler flowmetry over the mid-buccal aspect of the neighbouring second molar, with probe position reproduced by an individually made acrylic stent. Each recording lasts 30 seconds. A higher value indicates greater circulation.
3 secondary outcomes
Change in facial swelling
Time frame: Immediately before surgery, and on postoperative days 3 and 7
Change in maximum mouth opening
Time frame: Immediately before surgery, and on postoperative days 3 and 7
Duration of the operation
Time frame: Day of surgery (day 0), intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 17507264Kirk DG, Liston PN, Tong DC, Love RM. Influence of two different flap designs on incidence of pain, swelling, trismus, and alveolar osteitis in the week following third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jul;104(1):e1-6. doi: 10.1016/j.tripleo.2007.01.032. Epub 2007 May 15.
- Individual participant dataSharing planned: No. available from the corresponding author on reasonable request
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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.
Betül Taş Özyurtseven, DDS, PhD, Assoc. Prof. Dr. principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulcular flap elevation for wisdom tooth removal and Three-cornered flap elevation for wisdom tooth removal in people with Surgical Flaps and Oral Surgical Procedures, run by Betül Taş Özyurtseven 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 11 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in mucosal microcirculation adjacent to the operative field (time frame: Immediately before surgery, and on postoperative days 3 and 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07758192, which also lists 1 linked publication.
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 11 Aug 2026.