Novel Porcine Dermal Matrix Vs. Connective Tissue Graft in the Treatment of Multiple Adjacent Gingival Recessions of Miller Class I and II: a 12-month Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- mean root coverage (MRC)
研究概览
简要总结
The aim of this study was to assess the clinical efficacy of the acellular porcine derived collagen matrix (PADM) in comparison with connective tissue graft (SCTG ) in the treatment of multiple adjacent gingival recessions (MAGR). The primary objectives of the study were to evaluate mean and complete roots coverage. Additionally, the secondary objective was to evaluate and compare the clinical effectiveness of PADM and SCTG for the treatment of MAGR defects applying modified coronally advanced tunnel technique (MCAT).
详细描述
Treatment of multiple adjacent gingival recessions (MAGR) still presents a challenge for the clinician. The management of soft tissues becomes more complicated and the wound healing may be compromised by a variety of factors.
According to the available medical databases, predictable root coverage is possible for multiple-tooth recession defects using subepithelial connective tissue graft (SCTG) procedures. However, alternative materials to SCTG are supported by evidence of varying strength, with the need for additional research to confirm their performance and success rate. Because of that, the aim of this study was to assess the clinical efficacy of the acellular porcine derived collagen matrix (PADM) in comparison with connective tissue graft (SCTG ) in the treatment of multiple adjacent gingival recessions (MAGR).
This study is a randomised controlled clinical trial of 12 months duration. Sixteen patients with a total of 81 MAGR Miller's Class I or II were enrolled in this study. Recessions were randomly treated with PADM and SCTG, combined with a modified coronally advanced tunnel technique (MCAT). Several parameters, such as gingival recession coverage (RC), keratinized tissue width (KTW), keratinized tissue thickness (KTT) and clinical attachment level (CAL) were recorded at baseline and one year postoperatively. Healing index (HI) was registered on 1st, 2nd, and 3rd-week post-surgery in order to estimate healing events.
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
- Double (Participant, Investigator)
盲法说明
Single Blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least two multiple maxillaries or mandibular Miller's Class I and II recession, more than >2mm defects together with similar contralateral lesions
- •No active periodontal disease with PD>4mm
- •Absence of the radiographic signs of periapical infection on the teeth to be treated or on the adjacent teeth
- •A full mouth plaque index <20% and gingival index < 1
排除标准
- •The inflammatory periodontal disease/ Untreated periodontal conditions
- •Previous surgical attempt to correct gingival recession
- •Pregnant or breastfeeding women
- •Systemic diseases with compromised healing potential or infectious diseases
结局指标
主要结局
mean root coverage (MRC)
时间窗: 12 months
The percentage of covered recession area (MRC)
complete root coverage (CRC)
时间窗: 12 months
The percentage rate of patients with complete coverage of all recessions (CRC)
次要结局
- gingival recession width (GRW)(12 months)
- Gingival thickness (GT)(12 months)
- Clinical attachment level (CAL),(12 months)
- gingival recession (GR)(12 months)
- Keratinized tissue wide (KTW)(12 months)
研究者
Dragana Rakasevic
Doctor of dental medicine
University of Belgrade