The Use of a Connective Tissue Auto-graft in Combination With Either the Tunnel Technique or the Coronally Advanced Flap for the Treatment of Multiple Gingival Recession Defects. A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete root coverage
研究概览
简要总结
Many studies have compared the tunnel technique and coronally advanced flap in the treatment of single and multiple recessions. However, there is a lack of evidence that compared both techniques in combination with a connective tissue graft, for just multiple adjacent recessions. No technique is clearly superior to another in terms of complete root coverage (CRC), mean root coverage (MRC) and the gain of keratinized tissue height (KTH) when multiple recession coverage was evaluated. Moreover, as a connective tissue graft supposed to offer more stability in terms of complete root coverage in long-term basis, the main question should be aimed at the role of the sub-epithelial connective tissue graft, when it is used in combination with one technique or another. Hence, the hypothesis is focused on if the use of a connective tissue graft in combination with a tunnel technique would provide higher clinical outcomes and similar patient-based outcomes than its use in combination with the Coronally Advanced flap technique.
详细描述
Parallel group, clinical evaluator- and statistician-blinded, randomized clinical trial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A connective tissue graft will be harvested from the palate as a free gingival graft, which will be de-epithelialized with a 15-c blade(Zucchelli et al. 2010) before opening of the opaque envelopes, which contains the allocation concealment. Afterwards, test or control procedure will be carried out.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with a minimum of two adjacent teeth and a maximum of four adjacent teeth with gingival recessions (at least one with a depth ≥ 3 mm) and requiring surgical intervention, without medical contraindications to elective surgery.
排除标准
- •Presence of untreated periodontitis
- •Persistence of uncorrected gingival trauma from tooth brushing
- •Interdental attachment loss greater than 1 mm or furcation involvement in the teeth to be treated
- •Presence of severe tooth malposition, rotation or clinically significant super-eruption
- •Self-reported current smoking
- •Presence of medical contraindications to elective surgery
研究组 & 干预措施
CAF group
Coronally advanced flap in combination with a connective tissue graft.
According to the technique(Zucchelli & De Sanctis 2000), this procedure consists of a rotated papilla, envelope flap. Intrasulcular incisions will be performed involving all the experimental units and at least one tooth mesial and distal to the experimental teeth. From the centre of rotation the incisions will be traced in a corono-apical direction toward the mesial and toward the distal extension of the flap.
After the accurate initial incisions, the flap will be raised full thickness apical to the mucogingival junction (MGJ), exposing 1 to 2 mm of bone at the base of the recession/dehiscence defects.
A linear mesio-distal incision will then be performed to cut the periosteum, releasing any muscular tension and allow a passive coronal positioning of the flap to cover the CEJ.
干预措施: Connective tissue Harvest and CAF (Procedure)
Tunnel group
Tunnel technique in combination with a connective tissue graft.
When tunnelling procedures are applied, this technique consists of a supra-periosteal bed under a pedicle flap without any external incisions (Zabalegui et al. 1999). Afterwards, a connective tissue graft is placed and secured through the tunnel, covering the adjacent exposed roots.
To create a tunnel at the buccal aspect of the gingiva, sulcular partial-thickness incisions are made by means of a micro-blade through each recession area, extending the split-thickness beyond the mucogingival junction (MGJ). The partial dissection plane is then extended laterally through the papillae between the treated teeth without separating them. This incision must also be extended 3 to 5 mm mesial and distal from the lateral teeth to allow space for the connective tissue graft.
干预措施: Connective tissue Harvest and Tunnel (Procedure)
结局指标
主要结局
Complete root coverage
时间窗: 6 months
The complete root coverage is defined as the percentage of cases that 100% of the recessions will be covered in their whole extension.
次要结局
- Recession Reduction (RR)(6 months)
- Width of Keratinized Tissue (KTW)(6 months)
- Clinical attachment Gain(6 months)
- Wound Healing Index (WHI)(3 months)
- Mean Root Coverage(6 months)
- Probing pocket depth (PPD)(6 months)
- Root Coverage Aesthetic Score (Ref)(6 months)
研究者
Jerian González-Febles
Principal investigator
Universidad Complutense de Madrid