Extended Platelet- Rich Fibrin Membrane Combined With Vestibular Incision Subperiosteal Tunnel Access Technique as a New Treatment Modality for Localized Gingival Recession (Clinical Comparative Study)
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
- Root coverage percentage (RC%)
研究概览
简要总结
This study will be performed to clinically evaluate and compare the effectiveness of extended platelet-rich fibrin (e-PRF) membrane versus de-epithelized free gingival graft (DFGG) in combination with vestibular incision subperiosteal tunnel access (VISTA) in the treatment of localized Cairo gingival recession type 1 (RT1) defects.
The primary outcome of the present study will be the percentage of root coverage assessed after 6 months of surgical therapy whereas the secondary outcomes include the differences of gingival thickness, keratinized tissue width and dental hypersensitivity after 3 and 6 months.
详细描述
Gingival recession (GR) has been defined as the apical shift of the gingival margin in respect to the cementoenamel junction with concomitant exposure of the root surface in the oral cavity. Several etiological factors such as tissue phenotype, gingival thickness, brushing technique, non-carious and carious cervical lesions, and periodontal predisposition were identified for this condition, which may account for its relatively high incidence in the population .
When GR affects the esthetic area and is associated with dentinal hypersensitivity, exhibits a lack of an adequate band of keratinized tissue, or is concomitant with a carious or non-carious cervical lesion, treatment is often indicated. Indeed, the efficacy of surgical treatment for correction of GR defects has been extensively demonstrated with long-term stable outcomes .
With a broad variety of gingival recession cases with different clinical presentations, it is not always possible to classify all gingival recession defects according to one classification system. Several classifications have been proposed in literature to facilitate the diagnosis of gingival recessions. One of the most commonly used Cairo et al. classification (2011) which classified gingival recession based on the assessment of CAL at both buccal and interproximal sites into recession type 1, 2 and 3. This classification provides a simplified method of categorizing gingival recession and also emphasizes the role of interproximal attachment level, one of the important site-related prognostic factors .
Recession type 1 is characterized by gingival recession with no loss of interproximal attachment. Interproximal CEJ is clinically not detectable at both mesial and distal aspects of the tooth .
Several surgical techniques, such as guided tissue regeneration (GTR), subepithelial connective tissue graft procedure (SCTG), coronally advanced flap (CAF), laterally positioned flap, double papilla technique, semilunar pedicle flap, oblique rotated flap, tunnel technique (TUN), and surgical techniques based on modifications of these protocols have been proposed for the treatment of GR defects .
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
- 否
入选标准
- •Patients with Cairo recession type 1 (RT1): Gingival recession with no loss of interproximal attachment. Interproximal CEJ is clinically not detectable at both mesial and distal aspects of the tooth (15).
- •No systemic diseases.
- •Non-smokers.
- •Good oral hygiene and no bleeding on probing.
- •No history of previous mucogingival surgeries.
排除标准
- •Detected interproximal alveolar bone loss.
- •Pregnancy and lactating females
- •Heavy smokers.
- •Immunocompromised patients.
- •Fixed prosthesis in the site that will be treated.
- •Teeth with cervical caries, non-carious lesions or cervical fillings.
- •Bad oral hygiene.
研究组 & 干预措施
Group I (control group): Connective Tissue Graft to treat patient had RT1 Gingival Recession
15 patients will be treated with free gingival graft harvested from the hard palate then de-epithelized outside the oral cavity to be used in conjunction with VISTA technique for treatment of type 1 recession (RT1).
干预措施: Harvesting of Free Gingival Graft and preparation of CTG (Procedure)
Group I (control group): Connective Tissue Graft to treat patient had RT1 Gingival Recession
15 patients will be treated with free gingival graft harvested from the hard palate then de-epithelized outside the oral cavity to be used in conjunction with VISTA technique for treatment of type 1 recession (RT1).
干预措施: VISTA technique (Procedure)
Group 2 (study group): Alb prf membrane to treat patient had RT1 Gingival Recession
15 patients will be treated with extended platelet-rich fibrin (e-PRF) (Alb prf) membrane to be used in conjunction with VISTA technique for treatment of type 1 recession (RT1).
干预措施: VISTA technique (Procedure)
Group 2 (study group): Alb prf membrane to treat patient had RT1 Gingival Recession
15 patients will be treated with extended platelet-rich fibrin (e-PRF) (Alb prf) membrane to be used in conjunction with VISTA technique for treatment of type 1 recession (RT1).
干预措施: Preparation of Extended PRF (Other)
结局指标
主要结局
Root coverage percentage (RC%)
时间窗: 6 months
Root coverage percentage (%)
次要结局
- Gingival thickness (GT)(6 months)
- Width of keratinized gingiva (WKG):(6 months)
- Sensitivity visual analogue scale (Sens VAS)(6 months)
