Ultrasonographic Vascular Supply

July 22, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

Ultrasonographic Evaluation of the Vascular Supply After Coronally Advanced Flap Surgery in the Lower Jaw: a Clinical Case Series

Pre-operative ultrasound enables visualization of mandibular arterial branches relevant to flap design in mucogingival surgery. This study documents the pre-and post operative course of these arteries in four CAF procedures using a CE-marked ulstrasound device within its intended purpose.

Study Overview

Status

Completed

Detailed Description

Pre-operative ultrasound imaging offers a non-invasive method to visualize superficial arteries of the mandible and can complement the surgeon's anatomical knowledge when planning incisions for CAF procedures. By mapping the vascular network before surgery and comparing it with intra- and post-operative findings, clinicians can better understand how arterial patterns relate to surgical anatomy and flap perfusion.

This prospective case series documents four CAF procedures (single recession lower incisors, multiple recessions lower incisors, single recession lateral posterior, multiple recessions lateral posterior) performed in the mandibular anterior region, aiming to describe the course and variability of the mental, ascending mental, submental, and inferior labial arteries. The ultrasound system used is CE-marked and applied strictly within its intended purpose (soft-tissue imaging). The study seeks to enhance anatomical awareness.

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential participants will be identified and recruited during participant consultations at the department of periodontology. No additional recruitment material (such as for example flyers, social media advertising, audio/video recordings) will be used.

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Presence of at least one mandibular gingival recession defect (RT1 or RT2) at an anterior, canine, or premolar tooth with an indication for treatment using a coronally advanced flap (CAF).
  3. Good oral hygiene: full-mouth plaque score (FMPS) ≤ 20% and full-mouth bleeding score (FMBS) ≤ 20%.
  4. Periodontal stability: no active or untreated periodontitis; probing depths ≤ 4 mm at the study site.
  5. Ability to undergo pre-operative and post-operative ultrasound imaging and clinical documentation.
  6. No contraindication to local anaesthesia or minor periodontal surgery.
  7. Ability and willingness to comply with all scheduled follow-up visits (days 7, 14, 30 and 4 months).
  8. Provision of written informed consent prior to any study-related procedures.

Exclusion Criteria:

  1. Systemic contraindications to minor oral surgery (ASA ≥ III, uncontrolled diabetes mellitus [HbA1c > 7.5%], immunosuppressive therapy, bleeding disorders, or coagulation abnormalities).
  2. Current antithrombotic therapy that cannot be safely managed peri-operatively according to the treating clinician.
  3. Smoking more than 10 cigarettes per day or equivalent vaping within the previous 6 months.
  4. Previous mucogingival surgery, traumatic scarring, or soft-tissue grafting in the mandibular anterior or premolar region that could interfere with vascular assessment.
  5. Active oral infection or acute gingival inflammation at or near the study site.
  6. Untreated caries, endodontic pathology, or restorative defects at the involved tooth.
  7. Pregnancy or lactation.
  8. Known allergy or hypersensitivity to ultrasound gel or (if applied) indocyanine green (ICG) or iodine.
  9. Liver dysfunction or other medical contraindication precluding ICG use (relevant only if optional perfusion imaging is performed).
  10. Inability or unwillingness to comply with study procedures or follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation
Time Frame: Immediately after surgery
Correlation between pre-operative ultrasound findings and intra-/post-operative visualization of mandibular arterial branches (mental, ascending mental, submental, and inferior labial arteries), expressed as agreement in location, trajectory, and branching pattern
Immediately after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operative bleeding
Time Frame: during surgery
Incidence and severity of intra-operative bleeding (mild, moderate, severe)
during surgery
perfusion or ischemic changes
Time Frame: 14 days after surgery
Presence of perfusion or ischemic changes in the flap area, evaluated clinically
14 days after surgery
Clinical outcome: percentage of root coverage
Time Frame: 4 months after surgery
Clinical outcome including percentage of root coverage (%RC)
4 months after surgery
Clinical Outcome: Gain in keratinized tissue
Time Frame: 4 months after surgery
Clinical outcome, including gain in keratinized tissue (KT, mm)
4 months after surgery
Feasibility of pre-operative ultrasound mapping
Time Frame: 10 minutes before surgery
ability to visualize and identify relevant arterial branches before surgery (yes/no)
10 minutes before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andy Temmerman, professor, UZLeuven Department of Oral Health Sciences, Periodontology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2026

Primary Completion (Actual)

April 30, 2026

Study Completion (Actual)

June 30, 2026

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingival Recession, Generalized

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