NCT03862534已完成不适用
Coronally Advanced Flap (CAF) and Composite Restoration of the Enamel With or Without Connective Tissue Graft (CTG) for the Treatment of Single Maxillary Gingival Recession With Non-carious Cervical Lesion (NCCL). A Randomized Controlled Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Recession Reduction
研究概览
简要总结
This studies evaluate the efficacy of the coronally advanced flap (CAF) with or without connective tissue graft (CTG) for the treatment of single maxillary recession associated to non carious cervical lesion (NCCL).
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)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •No systemic diseases or pregnancy.
- •Self-reported smoking ≤ 10 cigarettes/day.
- •Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 10% (measured at four sites per tooth).
- •Presence of single RT1 buccal gingival recessions ≥ 2 mm of depth located in the anterior area of the upper jaw (central and lateral incisors, canine, first and second pre-molars, first molar) and associated with aesthetic complains and or dental sensitivity.
- •Presence of NCCL associated with recession
- •No history of mucogingival or periodontal surgery at experimental sites.
排除标准
- •Prosthetic crown at experimental teeth.
- •Gingival recessions presenting minimal amount (< 1mm) of apico-coronal keratinized tissue (KT) extension apical to recession area.
结局指标
主要结局
Recession Reduction
时间窗: At 12 months
Difference between gingival recession at 12 months and baseline, measured with a periodontal probe.
Complete Root Coverage (CRC)
时间窗: At 12 months
Absence or presence of gingival recession at 12 months follow-up.
次要结局
- Keratinized Tissue (KT)(Baseline - 6 and 12 months)
- SensVAS(Baseline - 6 and 12 months)
- Gingival Recesión (REC)(Baseline - 6 and 12 months)
- Anti-infammTab(1 week post-surgery)
- AesthVAS(At 12 months)
- Gingival Thickness (GT)(Baseline - 12 months)
- KTgain(At 12 months)
- Root sensitivity(Baseline - 6 and 12 months)
- Root coverage Esthetic Score (RES)(At 12 months)
- SurTime(At surgery)
- DiscVAS(1 week post-surgery)
研究者
Dr. Francesco Cairo
Head, Research Unit in Periodontology and Periodontal Medicine
University of Florence
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