Volumetric Changes at Edentulous Sites Augmented With Collagen Matrix or Connective Tissue Graft: a Randomized Clinical Trial With 6 Months Follow up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)
研究概览
简要总结
Ridge deformities can complicate prosthetic rehabilitation, especially in situations where optimal esthetic outcomes are desired. Simpler, less invasive and predictable treatments are needed in order to obtain soft tissue augmentation at edentulous ridges. Autogenous subepithelial connective tissue graft (SCTG) has always been regarded as the treatment of choice, but heterologous volume stable collagen matrix (VCMX) is emerging as a reliable alternative. The principal aim of the present RCT will be to compare the volumetric buccal soft tissue changes at edentulous areas after augmentation procedure using VCMX or SCTG. Parameters related to periodontal health at adjacent teeth and patient reported outcomes (PROMs) will be also assessed as secondary outcomes. Proving the non- inferiority of VCMX compared to SCTG would provide the specialists and general clinicians with an easier, less invasive and better tolerated technique for soft tissue augmentation at edentulous ridges and for improving aesthetic and cleansability of the prosthetic rehabilitation.
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 (Investigator, 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
- •Intercalated mono-edentulous area ridge defects to be rehabilitated with fixed partial bridge
- •At least 18 years old
- •At least 6 months from tooth extraction at the study area.
排除标准
- •Systemic diseases which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus);
- •Smoking ≥ 10 cigarettes a day;
- •Pregnant or nursing women;
- •Chronic use of corticosteroids or other anti-inflammatory or immune-modulator drugs;
- •Patients who need use of medications affecting bone metabolism or oral mucosa;
- •Presence of a congruous FDP at the edentulous area;
- •History of soft tissue augmentation surgery in the study area;
- •Active periodontitis
- •Uncompliant patients
结局指标
主要结局
Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)
时间窗: 6 months
Mean linear change in mm from baseline to 6 months follow-up
次要结局
- Pain (VAS scale)(0-10 with higher values indicating worse outcomes)(2 weeks)
- Mucosal recession at adjacent sites (0-15 mm with higher values indicating worse outcomes)(6 months)
- Change in Probing Pocket Depth (PD) at adjacent teeth (0-15 mm with higher values representing worse outcomes)(6 months)