Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix, Compared to the Connective Tissue Graft: A Parallel-arm, Randomized, Controlled, Assessor-blind, Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Mean root coverage (mRC)
研究概览
简要总结
The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.
详细描述
Currently the Connective Tissue Graft (CTG) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. This study test the non-inferiority of the Allogenic Dermal Matrix (ADM) with Platelet-Rich Fibrin (PRF) to that of the CTG, in terms of the amount of root coverage obtained after the procedure.
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
- Triple (Care Provider, 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
- •Periodontally and systemically healthy adults
- •Full-mouth plaque score and full-mouth bleeding score ≤ 20%
- •Presence of at least one 3 mm or deeper gingival recession, with at least 1.5 mm of Keratinized tissue, and 1 mm of gingival thickness) requiring surgical intervention for root coverage
- •No interproximal attachment/bone loss
- •No prior experience of root coverage procedures within the last 1 year
- •The patient must be able to perform good oral hygiene
排除标准
- •Contraindications for undergoing periodontal surgery
- •Teeth with more than Grade II mobility, or furcation involvement of Class III
- •Patients pregnant or attempting to get pregnant (self-reported), or nursing women
- •Untreated/active periodontitis, or other untreated acute infections at the surgical site
- •Untreated malignancies at the surgical site
- •Persistence of uncorrected gingival trauma from traumatic toothbrushing
- •Presence of severe tooth malposition, rotation or clinically significant super-eruption
- •Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking, or active tobacco chewing, or chronic vaping
- •Patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor XIII in plasma, or hemophilia
- •Patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation
- •Patients with known sensitivity to Polysorbate 20, Cefoxitin, Lincomycin, polymyxin B, Vancomycin
结局指标
主要结局
Mean root coverage (mRC)
时间窗: Assessed at 6 months
Measured as a percentage of the total baseline recession defect that coverage was obtained at.
Complete root coverage (CRC)
时间窗: Assessed at 6 months
Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect
Keratinized tissue (KT) gain
时间窗: Assessed at 6 months
Measured in mm
Duration of surgical procedure
时间窗: During surgery
Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes.
Gingival thickness (GT) gain
时间窗: Assessed at 6 months
Measured in mm
Patient-reported outcomes (PROMs)
时间窗: Measured from the day of the procedure up to a maximum of 1 month
In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest).
次要结局
- Soft tissue volume changes over time(Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months)
- Patient-reported post-operative pain as measured with a mobile application(From the day of the procedure until 1 month after the surgical time point)
- Patient-reported esthetics(Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results)
- Professionally evaluated esthetic score(Assessed at 6 months)
- Soft tissue blood flow changes over time(Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months)
- Patient-reported satisfaction(Measured at 6 months to provide the satisfaction score in VAS scale)
研究者
Hom-Lay Wang, DDS, MSD, Ph D
Professor
University of Michigan