Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions: a Multi-centre Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Mean Root Coverage (MRC) (6 months)
研究概览
简要总结
Included patients will be randomly allocated to the test (split-thickness non-advanced tunnel - Zabalegui et al. 1999) or to the control group (full-thickness coronally-advanced tunnel - MCAT - Aroca et al. 2010).
详细描述
Design: Randomized, clinical, outcome-assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio. The follow-up of individual patients will be 6 months (to be extended to 3/5 years if funding will be available)
Patients with a minimum of two-adjacent teeth with RT1 and/or RT2 gingival recessions (at least one with a depth >2 mm) with indication for root coverage treatment will be included. RT2 gingival recessions will be considered not eligible when associated with interproximal exposure of the CEJ.
Mean root coverage (linear) at 6-months will be evaluated as the primary outcome by a blinded outcome assessor.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient having a minimum of two adjacent teeth with RT1 and/or RT2 gingival recessions (at least one with a depth >2 mm) with indication for root coverage treatment, being at least 18 years old and able and agreeing to sign a written informed consent form will be potentially eligible for this trial. RT2 gingival recessions will be considered not eligible when associated with interproximal exposure of the CEJ (interdental gingival recession).
- •In case of multiple RT1/RT2 recessions involving 2 or 3 teeth, at least 2 or 1 more non-included adjacent teeth should respectively be present in order to guarantee a minimum of 4 adjacent teeth (including the included ones) in the region of interest (ROI) for digital scanning.
- •Patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local
排除标准
- •are found in the enrollment phase.
- •Systemic primary exclusion criteria:
- •Compromised general health which contraindicates the study procedures (ASA IV-VI patients);
- •Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
- •Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
- •Pregnant or nursing women;
- •Local primary exclusion criteria:
- •History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
- •Patients having had surgical soft tissue augmentation procedures in the ROI within the previous 12 months;
- •Furcation involvement in the teeth to be included;
- •Presence of severe tooth malposition, rotation or clinically significant super-eruption in the teeth to be treated;
- •Presence of fixed or removable prosthesis in the area to be treated;
- •Presence of RT3 gingival recessions in the same surgical area of the treatment.
- •Secondary exclusion criteria (after initial therapy is provided):
- •Not able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS < 20% and FMBS < 20%);
- •Persistence of uncorrected gingival trauma from toothbrushing.
研究组 & 干预措施
Split-thickness non-advanced tunnel (Zabalegui et al. 1999)
干预措施: Split-thickness non-advanced tunnel (Zabalegui et al. 1999) (Procedure)
Full-thickness coronally-advanced tunnel (Aroca et al. 2010)
Modified Coronally Advanced Tunnel (MCAT)
干预措施: Full-thickness coronally-advanced tunnel (Aroca et al. 2010) (Procedure)
结局指标
主要结局
Mean Root Coverage (MRC) (6 months)
时间窗: 6 months after surgery
Defined as the percentage of root coverage in the mid-buccal aspect obtained with respect to baseline. The MRC will be measured as a percentage (% mm, with probe) 6 months after surgery. Considering the study will also include RT2 gingival recessions (we expect CRC not possible in some cases), the linear 6 months MRC will be evaluated as the primary outcome of the study.
次要结局
- Recession Reduction (RR)(3 and 6 months after surgery)
- Contact-point/Papilla-tip (DCP) distance changes(3 and 6 months after surgery)
- Keratinized Tissue Height (KTH) changes(3 and 6 months after surgery)
- Probing Pocket Depth (PPD) changes(3 and 6 months after surgery)
- Clinical Attachment Level (CAL) changes(3 and 6 months after surgery)
- Dental hypersensitivity (DH)(3 and 6 months after surgery)
- Mean Root Coverage (MRC) (3 months)(3 months after surgery)
- Complete Root Coverage (CRC)(3 and 6 months after surgery)
- Root-coverage Esthetic Score (RES)(3 and 6 months after surgery)
- Digital Mean Root Coverage (dMRC)(3 and 6 months after surgery)
- Digital Complete Root Coverage (dCRC)(3 and 6 months after surgery)
- Digital Recession Reduction (dRR)(3 and 6 months after surgery)
- Digital Contact-point/Papilla-tip (dDCP) distance changes(3 and 6 months after surgery)
- Digital Gingival thickness (dGT)(3 and 6 months after surgery)
- Digital Keratinized Tissue Height (dKTH) changes(3 and 6 months after surgery)
研究者
Mario Romandini
Dr.
Universidad Complutense de Madrid