Xenogeneic Collagen Matrix or Palatal Connective Tissue Graft With a Coronally Advanced Flap for the Treatment of Miller Class III Gingival Recessions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of root coverage
研究概览
简要总结
The purpose of this multi-center study is to compare the effectiveness of Mucograft versus connective tissue graft in combination with coronal advanced flap for the treatment of Miller class III recessions The connective tissue graft in combination with coronal advanced flap is considered the gold standard for the treatment of gingival recession in terms of percentage of root coverage and complete root coverage. However connective tissue graft harvesting from the palatal mucosa is often associated with increased patient morbidity, prolonged surgical time and is limited supply. To overcome these inconvenients many efforts are made to develop new materials (healing modifiers, barrier membranes and grafts substitutes) Recently a new two-layer , xenogenic collagen matrix (Mucograft: Geistlich Pharma , Wolhusen Switzerland) has been proposed for regenerative therapy involving teeth and implants. The use of this porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects (isolated and multiple recession defects) The mayority of root coverage studies in the literature treats Miller class I and II recession defects .Surgical treatment of class III recesión defects is more challenging due to loss of interproximal bone and soft tissues and complete root coverage may not be expected . But some recent studies demonstrate complete root coverage and high percentage of root coverage in class III recessions. Also a new classification system using the level of interproximal attachment level has been proposed to predict the final root coverage outcome.
So ,the soft tissue substitutes should be used also in Miller class III recession, and because of that fact, the investigators are conducting this study, to evaluate the effectiveness of Mucograft in Miller class III recessions compared with connective tissue graft.
详细描述
Given data reported by the study of Aroca in 2013 ,using the percentage of root coverage as a primary response variable the sample size was estimated in 20 patients. In addition, taking into account possible drop-outs, the investigators would increase the number of patients by 20%, finally recruiting 24 patients per group.
Randomization was performed by computer generated random codes Study locations will include two private centers in Spain. A single calibrated examiner, blind with respect to the treatment assignment, will perform all measurements at all center.
A biostatistician blind with respect to treatment assignment will perform the analysis.
Interventions and Duration The two intervention groups will consist of surgery with connective tissue graft (standard of care control) and surgery with the application of Mucograft Collagen Matrix (MCM, Test group). Experienced clinicians will deliver treatment consisting of root coverage surgery using coronally advanced flaps, the most utilized procedure for coverage of recessions. Surgery will be standardized and the same procedures/materials will be employed to ensure consistency.
Follow-up of individual patients will be 12 months.
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
- Single (Outcomes Assessor)
盲法说明
Observer: Another periodoncist outside the intervention, would be in charge of recording the clinical parameters.
Analyst: The statistician does not know which treatment corresponds to each variable.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient must be 18 years or older
- •Patient with one or more recession defects are Miller Class III in incisives, canines and premolars. In at least two quadrants
- •Patient shows sufficient plaque control (FMPS < 20%).
- •Treated periodontal conditions
- •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
- •General contraindications for dental and/or surgical treatment are present.
- •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).
- •Untreated periodontal conditions
- •Patients not willing to participate
结局指标
主要结局
Percentage of root coverage
时间窗: Change from baseline at following surgery sixth and twelfth month respectively
In each patient the mean of their gingival recessions at baseline (initial RECm)and at 6 (RECm 6months)and 12 months (RECm 12 months) will be calculated measuring at the mid buccal point of the involved teeth by the same blinded investigator using the same periodontal probe (PCP SE-11 Hu Friedly, Chicago, IL USA). With this measurements the percentage of root coverage will be calculated
次要结局
- Percentage of recessions with Complete root coverage(Change from baseline at following surgery sixth and twelfth month respectively)
- Clinical Attachment Level(Change from baseline at following surgery sixth and twelfth month respectively)
- Recession width(Change from baseline at following surgery sixth and twelfth month respectively)
- Aesthetic results(12 months)
- Time of surgery(After surgery up to 7 days)
- Gingival Thickness(Change from baseline at following surgery and twelfth month respectively)
- Keratinized Tissue width(Change from baseline at following surgery sixth and twelfth month respectively)
- Patient centred outcomes(after surgery up to 7 days and 1 year)
研究者
Elena Ruiz de Gopegui Palacios
Principal Investigator
University of the Basque Country (UPV/EHU)