Treatment of Multiple Gingival Recession Defects With a Coronally Advanced Flap or a Modified Tunnel Technique and a Volume Stable Three-dimensional Xenogeneic Collagen Matrix: a Monocentric Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- percentage (%) of complete root coverage (CRC)
研究概览
简要总结
In a recent meta-analysis, Graziani et al. reported that despite the "ideal" treatment for multiple gingival recession defects is not yet identified, there are some indirect suggestions from the analyzed data that, in comparison to the traditional coronally advanced flap (CAF) approach, the use of additional grafting, modifications of the flap technique or tunnel variation with connective tissue graft (CTG) may improve clinical results.
Furthermore, various allografts or replacement biomaterials have been developed instead of a connective tissue graft in order to reduce patient morbidity. A newly developed porcine-derived bio-resorbable collagen matrix (CM) (Fibro-Gide) has been recently introduced as an alternative to CTG in periodontal plastic surgery.
The aim of this study will be to compare the outcomes of two muco-gingival surgery techniques, the modified coronali advanced flap (MCAF) for multiple recession defects and the modified coronally advanced tunnel technique (MCAT), performed in the Department of Periodontology of San Raffaele Hospital with the results reported in the literature.
Secondarily, the study will evaluate whether patients report a preference in terms of discomfort and perception of aesthetics between the two surgical techniques.
详细描述
The present research is a monocentric prospective parallel randomized controlled clinical trial.
Patients presenting multiple gingival recessions in the maxillary will be enrolled in the study after having signed an informed consent. Recessions will be treated by means of two mucogingival surgery techniques: modified coronally advanced flap (MCAF) and modified coronally advanced tunnel technique (MCAT), in association with the use of a collagen matrix (CM).
Two experienced practitioners (M.d.S. and S.A.) will perform the surgical session according to the technique as presented by Zucchelli & de Sanctis 2000 and Aroca et al. 2013.
- Modified coronally advanced flap (MCAF): After local anesthesia, a horizontal incision is made to include one tooth on each side of the teeth to be treated. The horizontal incision of the envelope flap consists of oblique sub-marginal incisions in the interdental areas, incisions which continue with the intra-sulcular incision at the recession defects.
Each surgical papilla (SP) is dislocated with respect to the anatomic papilla by the oblique sub-marginal interdental incisions; in particular, the surgical papilla mesial to the flap midline are dislocated more apically and distally, while the papilla distal to the mid-line are shifted in a more apical and mesial position.
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
- None
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
- •multiple (i.e., at least 2) Miller Class I and/or II gingival recessions located in the maxillary, with an apico-coronal extension (i.e., defect depth > 1 mm with at least one defect > 2 mm) and with at least 1 mm of residual keratinized tissue,
- •good general health, with no systemic diseases that could influence the outcome of the therapy,
- •healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites),
- •adequate oral hygiene (full mouth plaque score (FMPS) of <25% at baseline (following initial oral hygiene instructions and prophylaxis),
- •an adequate control of inflammation (full mouth bleeding score [FMBS]) of <25% at baseline (following initial oral hygiene instructions and prophylaxis).
排除标准
- •subjects who currently smoke >10 cigarettes/day,
- •female subjects who are nursing, pregnant, or plan to become pregnant,
- •contraindication against oral surgical interventions,
- •contraindication against use of Fibro-Gide (acute infection in the area of surgery and patient with collagen allergy)
研究组 & 干预措施
MCAF+CM
Modified coronally advanced flap + collagen matrix
干预措施: MCAF+CM (Procedure)
MCAT+CM
Modified coronally advanced tunnel technique + collagen matrix
干预措施: MCAT+CM (Procedure)
结局指标
主要结局
percentage (%) of complete root coverage (CRC)
时间窗: 12 months
Ratio scale - higher values represent a better result
次要结局
- gingival thickness (GT)(3, 6 and 12 months)
- keratinized tissue width (KTW)(3, 6 and 12 months)
- percentage of root coverage (RC %)(3, 6 and 12 months)
- post-surgical pain (PP),(1 week after surgery)
研究者
Massimo de Sanctis
Professor
Università Vita-Salute San Raffaele