NCT07758192

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

mouth openingswellingmucosal perfusionpulp circulationlaser Doppler flowmetryvertical releasing incisionmucoperiosteal flapimpacted wisdom tooth

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Immediately before surgery, and on postoperative days 3 and 7

Secondary Outcomes (3)

  • Change in facial swelling

    Immediately before surgery, and on postoperative days 3 and 7

  • Change in maximum mouth opening

    Immediately before surgery, and on postoperative days 3 and 7

  • Duration of the operation

    Day of surgery (day 0), intraoperative

Study Arms (2)

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.

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.

Procedure: Three-cornered flap elevation for wisdom tooth removal

Interventions

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.

Also known as: Intervention 1
Sulcular (envelope) flap

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

Three-cornered (trapezoidal) flap

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Gaziantep, Gaziantep, 27310, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 17507264BACKGROUND

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Betül Taş Özyurtseven, DDS, PhD, Assoc. Prof. Dr.

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Oral and Maxillofacial Surgery, Senior Researcher / Clinician

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 11, 2026

Study Start

November 9, 2020

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

available from the corresponding author on reasonable request

Locations