Adjunctive Benefit of a Xenogenic Collagen Matrix Associated With Coronally Advanced Flap for Treating Multiple Gingival Recessions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Mean Recession Reduction
研究概览
简要总结
The present CONSORT-based randomized clinical trial is to assess the adjunctive benefit of a xenogenic collagen matrix in combination with a coronal advanced flap with respect to a coronal advanced flap alone in the treatment of multiple gingival recession defects in adult population.
详细描述
This is a single-centre, superiority, double blind clinical trial, with balanced randomisation and parallel two groups design. The 2 groups will be:
- CAF combined with XCM;
- CAF alone.
The objective is therefore to assess the adjunctive benefit of a xenogenic collagen matrix in combination with a coronal advanced flap.
The primary endpoint is the mean recession reduction after 6 and 12 months post treatment.
The secondary endpoints are: Percentage of complete root coverage after 6 and 12 month; Thickness of soft tissue over the root after 6 and 12 month; Recession width after 6 and 12 month; KT width; Patients satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient (male or female) must be 18 years or older
- •Presence of gingival recessions in the upper jaw, involving teeth from central incisor to first molar
- •Gingival recessions on at least 2 adjacent teeth with a minimal depth of 2mm and detectable cemento-enamel junction (CEJ) (abrasion step <1mm)
- •The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
- •Full Mouth Plaque (FMPS) and Bleeding (FMBS) Score <20%
- •The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent
排除标准
- •Smoker patients
- •Pregnant patients
- •Patients affect by uncontrolled diabetes
- •General contraindications for dental and/or surgical treatment are present
- •History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years
- •The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs, anticoagulation drugs)
- •The patient has a disease, which affects connective tissue metabolism (e.g. collagenases)
- •The patient is allergic to collagen
- •The patient is an abuser of alcohol or drug
- •Patients have participated in a clinical trial within the last six months
- •Presence of untreated periodontitis
- •Gingival recessions on molar teeth (excluding the first) or on malpositioned teeth
- •Presence of abrasion ≥ 1 mm or cervical restoration, with non-detectable CEJ
研究组 & 干预措施
CAF+XCM
An envelope split-full-split thickness flap without vertical incisions will be carried out in the gingival recession area. Afterwards, a xenogenic collagen matrix (XCM) will be applied to all teeth with recession defect. The XCM will be cut into the right dimensions, measured with the probe, and its measurements recorded; then it will be placed from the CEJ to the bone crest on the recipient bed using single sutures, 7/0 PGA sutures. The matrix will be rehydrated with blood, in order to reconstitute and maintain the maximal thickness possible. The flap will be closed slightly coronal to the CEJ with a sling suture using resorbable PGA 6/0 sutures and avoiding any compression of the matrix.
干预措施: CAF+XCM (Procedure)
CAF alone
An envelope split-full-split thickness flap without vertical incisions will be carried out. The root surfaces will be mechanically treated with the use of curettes. A sharp dissection into the vestibular lining mucosa will be then carried out to eliminate muscle tension. Sling sutures will be performed to accomplish a precise adaptation of the buccal flap on the exposed root surfaces and to stabilize every single surgical papilla over the de-epithelialized anatomic papillae.
干预措施: CAF alone (Procedure)
结局指标
主要结局
Mean Recession Reduction
时间窗: 12 months
The distance between CEJ and the free gingival margin (Rec depth) will be measured at baseline, 3, 6 and 12 months. The mean change will be then calculated.
次要结局
未报告次要终点
研究者
Roberto Rotundo
Principal Investigator
Rotundo, Roberto, DDS