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Gingival Recession, GeneralizedNCT07727707

Ultrasonographic Vascular Supply

An observational study of Gingival Recession, Generalized, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gingival Recession, Generalized
How many people
4 participants
Where
1 siteBelgium
Study dates
2 Apr 2026to 30 Jun 2026
How long will I take part?
4 Months
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Age ≥ 18 years.
  • 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).
  • Good oral hygiene: full-mouth plaque score (FMPS) ≤ 20% and full-mouth bleeding score (FMBS) ≤ 20%.
  • Periodontal stability: no active or untreated periodontitis; probing depths ≤ 4 mm at the study site.
  • Ability to undergo pre-operative and post-operative ultrasound imaging and clinical documentation.
  • No contraindication to local anaesthesia or minor periodontal surgery.
  • Ability and willingness to comply with all scheduled follow-up visits (days 7, 14, 30 and 4 months).
  • Provision of written informed consent prior to any study-related procedures.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Keywords
ultrasonography, Vascular supply, Mucogingival surgery, Coronally Advanced Flap Surgery, arterial structure, visualization
Medical subject headings
Gingival Recession

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation

    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

    Measured: Immediately after surgery

Secondary outcomes (5)

  1. Intra-operative bleeding

    Incidence and severity of intra-operative bleeding (mild, moderate, severe)

    Measured: during surgery

  2. perfusion or ischemic changes

    Presence of perfusion or ischemic changes in the flap area, evaluated clinically

    Measured: 14 days after surgery

  3. Clinical outcome: percentage of root coverage

    Clinical outcome including percentage of root coverage (%RC)

    Measured: 4 months after surgery

  4. Clinical Outcome: Gain in keratinized tissue

    Clinical outcome, including gain in keratinized tissue (KT, mm)

    Measured: 4 months after surgery

  5. Feasibility of pre-operative ultrasound mapping

    ability to visualize and identify relevant arterial branches before surgery (yes/no)

    Measured: 10 minutes before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start2 Apr 2026
  3. Primary completion30 Apr 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
4 participants (actual)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07727707
Sponsor's protocol ID
S71602
Status last verified
Jul 2026
First submitted
17 Jul 2026
Last updated
27 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gingival Recession, Generalized, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

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 8 inclusion and 10 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 27 Jul 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 Belgium. 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?

Correlation (time frame: Immediately after surgery). 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 NCT07727707.

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 27 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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