Comparison of Graft Quality and Patient Morbidity Following Four Different Connective Tissue Graft Harvesting Techniques. A Randomized Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Patient morbidity (VAS)
研究概览
简要总结
The purpose of this study is to compare four different connective tissue graft harvesting technique in terms of graft quality and patient post-operative morbidity
详细描述
The primary aim is to compare 4 different connective tissue graft harvesting techniques in terms of morbidity and in terms of quality of the graft.
The secondary aim is to evaluate the outcome of gingival recessions treated with grafts obtained from different harvesting approaches, in terms of mean root coverage, complete root coverage, keratinized tissue gain, clinical attachment level gain and gingival thickness
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
- •18 years of age or greater,
- •Patients with no reported systemic diseases,
- •Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy,
- •Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of < 15%,
- •Clinical indication for periodontal plastic surgery utilizing CTG to treat either a single or a maximum of two recession defects (Miller class I, II) around natural teeth
- •No history of previous palatal harvesting
排除标准
- •Pregnancy
- •Systemic condition that generally precludes surgical therapy or that could influence the outcome of therapy (e.g. Diabetes with HbA1c > 7%, INR > 3 etc.)
- •Non-compensated systemic disease
- •Poor oral hygiene with full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) > 20% at baseline
- •Inadequate endodontic treatment or tooth mobility at the site of surgery
- •Radiographic evidence of bone loss
结局指标
主要结局
Patient morbidity (VAS)
时间窗: 14 days
Patient post-operative pain measured using a VAS scale
Mean root coverage (mRC)
时间窗: 6 months
mRC measured as a percentage
次要结局
- Keratinized tissue (KT) gain(6 months)
- Painkillers consumption(14 days)
- Root coverage Esthetic Score (RES)(6 months)
- Clinical attachment level (CAL) gain(6 months)
- Gingival thickness (GT)(6 months)
- Patient willingness for retreatment(14 days)
研究者
Giulio Rasperini
Professor of Periodontology
University of Milan