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Completed

NCT Number: NCT07727707

Ultrasonographic Vascular Supply

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Intra-operative bleeding

    Time frame: during surgery

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

  2. perfusion or ischemic changes

    Time frame: 14 days after surgery

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

  3. Clinical outcome: percentage of root coverage

    Time frame: 4 months after surgery

    Clinical outcome including percentage of root coverage (%RC)

  4. Clinical Outcome: Gain in keratinized tissue

    Time frame: 4 months after surgery

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

  5. Feasibility of pre-operative ultrasound mapping

    Time frame: 10 minutes before surgery

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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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