- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07727707
Ultrasonographic Vascular Supply
Ultrasonographic Evaluation of the Vascular Supply After Coronally Advanced Flap Surgery in the Lower Jaw: a Clinical Case Series
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgium, 3000
- UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation
Time Frame: Immediately after surgery
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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
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Immediately after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intra-operative bleeding
Time Frame: during surgery
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Incidence and severity of intra-operative bleeding (mild, moderate, severe)
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during surgery
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perfusion or ischemic changes
Time Frame: 14 days after surgery
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Presence of perfusion or ischemic changes in the flap area, evaluated clinically
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14 days after surgery
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Clinical outcome: percentage of root coverage
Time Frame: 4 months after surgery
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Clinical outcome including percentage of root coverage (%RC)
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4 months after surgery
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Clinical Outcome: Gain in keratinized tissue
Time Frame: 4 months after surgery
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Clinical outcome, including gain in keratinized tissue (KT, mm)
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4 months after surgery
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Feasibility of pre-operative ultrasound mapping
Time Frame: 10 minutes before surgery
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ability to visualize and identify relevant arterial branches before surgery (yes/no)
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10 minutes before surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Andy Temmerman, professor, UZLeuven Department of Oral Health Sciences, Periodontology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S71602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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