An Open Prospective Randomized Controlled Clinical Trial to Examine the Efficacy of Methods to Treat Multiple Gingival Recession Defects
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Complete root coverage
研究概览
简要总结
Rationale: Treatment of gingival recession defects requires coronal advancement of the gingival margin due to patient esthetic demand, tooth sensitivity and improvement of tooth prognosis, which can be accomplished either through a flap procedure or through a tunnel. It will be desirable to determine the efficacy of Vestibular Incision Subperiosteal Tunnel Access (VISTA) to Coronally Advanced Flap (CAF) procedure and intrasulcular tunneling.
Another aspect of the study is to determine whether autologous concentrate of platelets and leukocytes (leukocyte-platelet-rich fibrin; L-PRF) has equivalent efficacy to connective tissue autologous graft harvested from the palate.
The overall objective of this study is to evaluate the effectiveness of therapeutic modalities for the treatment of multiple gingival recession defects.
The study is designed as a prospective, randomized controlled clinical trial. Four groups will be compared:
Group 1: Coronally Advanced Flap (CAF) Group 2: VISTA Group 3: Intrasulcular tunneling (IST) Group 4: VISTA + L-PRF
Each of the groups will be treated without any graft material in order to examine the efficacy of coronal advancement and periodontal root coverage without the confounding variable of graft material. These techniques don't require any additional graft if there is adequate amount of keratinized gingiva
The study population will be patients who present to Advanced Graduate Program in Periodontology at the University of Southern California, USA, and are deemed to require treatment of multiple gingival recession defects. A total sample of 100 participants (23 participants per group) will provide a two sided test of means with 80% power at alpha of 0.05. The calculation was carried out using PASS Version 12 (Hintze, J. (2014). NCSS, LLC. Kaysville, Utah.)
The study duration will be 1 year. Follow-up visits after the surgery will occur after 3 days , 7 days and at weeks 3, 6, 12, 24, 36 and 52. These follow up visits consistent with standard of care follow up for gingival recession treatment and there will be no additional costs to the participant.
The Primary Outcome variable is complete root coverage; the Secondary Outcome Variables are clinical attachment level (CAL) gain, changes in gingival thickness and volume and the Tertiary Outcomes are aesthetic outcomes, postoperative pain and Patient satisfaction survey
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female individuals between ages of 18 to 70 years old
- •Multiple contiguous gingival recession defects on a minimum of two adjacent teeth, exhibiting 3mm or more recession on at least one of those teeth
- •No prior surgical treatment in the sites planned for therapy
- •Minimum of 2 mm of keratinized gingiva
- •Absence of cervical restorations extending to the CEJ
- •Miller class 1, 2 and 3 recession defects will be included
- •Availability to undergo treatment and return for follow up visits at specified post-operative intervals
排除标准
- •Molar teeth
- •Milller Class 4 recession defects
- •Pregnancy (Self-reported)
- •Uncontrolled local or systemic diseases that affects wound healing (diabetes, autoimmune or inflammatory disorders)
- •Past history of systemic steroid use over 2 weeks within the last 2 years
- •Poor oral hygiene on a non-compliant individual
- •Ibuprofen Allergy/interlerance
- •Anticoagulant therapy (e.g. Warfarin, Plavix, etc.), will not be automatic exclusion but patients will be required to have INR test performed and have values between 2.0 to
- •Physician consultation will be requested to determine whether anticoagulant therapy can be discontinued for 3 days prior to surgery.
- •Objection to blood draw or application of blood products
- •Students and staff from USC Ostrow school of Dentistry will not be recruited for this study
研究组 & 干预措施
Coronally Advanced Flap
干预措施: Coronally Advanced Flap (Procedure)
Vestibular Incision Subperiosteal Tunnel Access (VISTA)
干预措施: Vestibular Incision Subperiosteal Tunnel Access (VISTA) (Biological)
Intrasulcular tunneling
干预措施: Intrasulcular Tunneling (Procedure)
VISTA + Leukocyte-Platelet Rich Fibrin
干预措施: Vestibular Incision Subperiosteal Tunnel Access (VISTA) (Biological)
VISTA + Leukocyte-Platelet Rich Fibrin
干预措施: Leukocyte-Platelet Rich Fibrin (L-PRF) (Device)
结局指标
主要结局
Complete root coverage
时间窗: 12 months
Complete coverage of the recession defect following surgery. It will be a binary outcome (Yes or No)
次要结局
- Gingival Volume Gain(12 months)
- Clinical Attachment Level gain(12 months)
- % root coverage(12 months)
- Gingival Thickness Gain(12 months)
研究者
Neema Bakhshalian
Assistant Professor
University of Southern California