Ultrasonographic Evaluation of the Vascular Supply After Coronally Advanced Flap Surgery in the Lower Jaw: a Clinical Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Correlation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Correlation
时间窗: 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
次要结局
- Intra-operative bleeding(during surgery)
- perfusion or ischemic changes(14 days after surgery)
- Clinical outcome: percentage of root coverage(4 months after surgery)
- Clinical Outcome: Gain in keratinized tissue(4 months after surgery)
- Feasibility of pre-operative ultrasound mapping(10 minutes before surgery)