The Influence of Non-Carious Cervical Lesions on Root Coverage by Means of Coronally Advanced Flap and a Connective Tissue Graft: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Mean Root Coverage (MRC)
研究概览
简要总结
The goal of this prospective cohort study is to evaluate the effect of non-carious cervical lesions (NCCLs) on the outcome of root coverage therapy. The main question it aims to answer is: In gingival recessions associated with NCCLs, characterized by an undetectable cemento-enamel junction (CEJ), reconstruction of the CEJ with a cervical composite restoration, prior to root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft (CAF+CTG), provides similar clinical and patient-reported outcomes, as compared to the treatment of gingival recessions associated with NCCLs, characterized by a visible CEJ, with root coverage surgery only, by means of a CAF+CTG.
In NCCLs where the CEJ is undetectable (B-type defect), the CEJ will be reconstructed before surgery with a cervical composite restoration mimicking the anatomic features of the contralateral, homologous tooth. CAF+CTG treatment will be performed in all cases. Participants will be assessed at 6 weeks, 3 months, and 6 months to evaluate clinical, volumetric, and patient-centred outcomes.
详细描述
In this investigation, a prospective cohort study, several key outcomes will be assessed. First, we seek to determine whether restoring the cementoenamel junction (CEJ) in Class B GRs before root coverage therapy yields comparable clinical and volumetric outcomes to Class A GRs with detectable CEJ. In addition, the influence of the CEJ restoration on dentin sensitivity and aesthetic satisfaction of the patient will be investigated. To our knowledge, it will be the first clinical study to use Pini Prato et al.'s surface discrepancy classification as a decision-making tool to guide periodontal-restorative procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Systemically healthy individuals older than 18 years old;
- •Healthy periodontal status according to the AAP/EFP definition;
- •Full-mouth plaque (FMPS) and bleeding scores (FMBS) ≤ 20%;
- •At least one facial RT1 GR in single-rooted teeth with a minimum depth of 2 mm, associated with a NCCL;
- •No history of periodontal surgery at the experimental site(s).
排除标准
- •Pregnancy or lactation;
- •Self-reported smoking ≥10 cigarettes/day;
- •Metabolic diseases that negatively affect soft tissue healing (i.e., diabetes mellitus);
- •Any medication that may interfere with wound healing;
- •Prosthetic crown at experimental teeth;
- •Ongoing orthodontic therapy.
结局指标
主要结局
Mean Root Coverage (MRC)
时间窗: 6 months
Mean root coverage assessed in percentage
次要结局
- Change in marginal gingival thickness (ΔMGT)(6 weeks, 3 months, 6 months)
- Change in recession depth (ΔRD)(6 weeks, 3 months, 6 months)
- Change in recession area (ΔRA)(6 weeks, 3 months, 6 months)
- Patient aesthetic satisfaction as assessed by VAS (Visual Analog Scale)(6 months)
- Probing pocket depth (PPD)(6 months)
- Clinical attachment level (CAL)(6 months)
- Dentin sensitivity as assessed by VAS (Visual Analog Scale)(Initial, 6 months)
- Complete Root Coverage (CRC)(6 months)
- Change in keratinized tissue width (ΔKTW)(6 weeks, 3 months, 6 months)
- Change in mucosal volume (ΔMV)(6 weeks, 3 months, 6 months)
研究者
Gonzalo Blasi
Clinical professor
Universitat Internacional de Catalunya