Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap. A Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- CRC
研究概览
简要总结
Aim: to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion, comparing a "split-full-split" thickness flap elevation versus a "split" thickness approach performed during CAF for the treatment of isolated-type gingival recessions in the upper jaw.
Material and Methods: forty patients were randomized, 20 were treated with "split-full-split" (test group) and 20 with a "split" approach (control group). Analyzed parameters at 1 year were: CRC, percentage of Recession Coverage (RC), Keratinized tissue (KT) gain, patient-related outcome measurements.
详细描述
Treatment of buccal gingival recession (GR) is the common clinical requirement from patients who are mainly concerned about aesthetics. Noteworthy are also requests linked to root sensitivity, difficulty in oral hygiene procedures, presence of root caries and non-carious cervical lesions. GR defects, when left untreated, do not improve spontaneously and may progress toward increased recession depth (RD) and clinical attachment loss which increase the patient's aesthetic concern and the clinical discomfort due to augmented dental hypersensitivity.
Complete root coverage (CRC) can be considered the primary clinical outcome and selecting the surgical technique depends mainly on the local anatomical characteristics and on the patient's demands.
In patients with a residual amount of keratinized tissue apical to the recession defect, the coronal advanced flap (CAF) may be recommended. This surgical technique results in optimal root coverage, good color blending of the treated area with respect to adjacent soft tissues and a complete recovery of the original (pre-surgical) soft tissue marginal morphology. Furthermore, post-operative morbidity is reduced to a single area of surgical intervention and the overall chair time is limited.
When utilizing CAF technique, critical factors in CRC have been described in the literature. Flap positioning coronal to the CEJ and a tension-free flap design are among the most important ones. Moreover, flap thickness has been shown to influence the clinical outcomes of CAF procedure .
Coronally advanced flap has been widely validated by the literature for the treatment of single recession defects and, currently, different flap designs and technical modifications are available to clinicians.
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
- •age >18 years,
- •no systemic diseases or pregnancy,
- •smoking ≤10 cigarettes/day,
- •full-mouth plaque score and full-mouth bleeding score ≤20%,
- •presence of at least one Miller class I or II isolated recession defect (Miller, 1985) in the upper jaw and at least 2 mm of keratinized tissue apical to the recession,
- •recession depth (RD) equal to or greater than 2mm,
- •identifiable cemento-enamel junction (CEJ),
- •vital teeth, free from caries or prosthetic crown,
排除标准
- •systemic diseases or pregnancy,
- •history of periodontal surgery at experimental sites.
研究组 & 干预措施
Split Full Split Elevation of CAF
The central portion of the flap apical to the recession was elevated full thickness by the use of a small periostium elevator inserted into the probable sulcus
干预措施: CAF (Procedure)
Split Elevation of CAF
The flap was fully elevated with a split thickness approach: the blade of the knife was inserted into the sulcus
干预措施: CAF (Procedure)
结局指标
主要结局
CRC
时间窗: 12 months
Percentages of recession with a Complete Root Coverage
次要结局
- VAS esthetic(12 months)
- RC(12 months)
- VAS discomfort(12 months)
- VAS satisfaction(12 months)
- KTH(12 months)
研究者
Prof. Marco Ferrari
Full Professor
University of Siena
