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Ultrasonographic Vascular Supply

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07727707
Enrollment
4
Registered
2026-07-27
Start date
2026-04-02
Completion date
2026-06-30
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession, Generalized

Keywords

ultrasonography, Vascular supply, Mucogingival surgery, Coronally Advanced Flap Surgery, arterial structure, visualization

Brief 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.

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.

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CorrelationImmediately after surgeryCorrelation 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

MeasureTime frameDescription
Intra-operative bleedingduring surgeryIncidence and severity of intra-operative bleeding (mild, moderate, severe)
perfusion or ischemic changes14 days after surgeryPresence of perfusion or ischemic changes in the flap area, evaluated clinically
Clinical outcome: percentage of root coverage4 months after surgeryClinical outcome including percentage of root coverage (%RC)
Clinical Outcome: Gain in keratinized tissue4 months after surgeryClinical outcome, including gain in keratinized tissue (KT, mm)
Feasibility of pre-operative ultrasound mapping10 minutes before surgeryability to visualize and identify relevant arterial branches before surgery (yes/no)

Countries

Belgium

Contacts

PRINCIPAL_INVESTIGATORAndy Temmerman, professor

UZLeuven Department of Oral Health Sciences, Periodontology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026