Clinical and Biochemical Effects of the Adjunctive Use of a Polynucleotides and Hyaluronic Acid Based Gel in the Subgingival Re-instrumentation of Residual Periodontal Pockets: a Randomized, Split-mouth Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pocket depth
研究概览
简要总结
The purpose of this randomized controlled clinical trial (RCT) was to investigate the clinical and biochemical efficacy of a gel containing PDRN and HA used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.
详细描述
The aim of the present study was to investigate the clinical and biochemical efficacy of a gel containing polynucleotides (PDRN) and hyaluronic acid (HA) used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.
50 patients were enrolled in a randomized, split-mouth clinical trial. For each patient, two teeth with similar residual pockets with probing depth (PD) ≥ 5 mm were selected to receive re-instrumentation with (test) or without (control) the adjunctive use of a PDRN and HA based gel. Differences in changes of PD, gingival recession (REC), clinical attachment level (CAL), modified sulcular bleeding index (mSBI), plaque index (PLI) from baseline to 6, 8, 24, 36 and 48 weeks were analyzed and the frequencies of sites with PD <4 mm at 48 weeks were compared. Furthermore, changes in the dosage of alpha-2-macroglobulin (α2M) and of matrix metalloproteinase-9 (MMP-9) from baseline to 6 weeks were evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males and females with ≥ 18 years
- •stage 3 generalized periodontitis
- •3-6 months after step 1 and 2 of periodontal treatment, at least two non-adjacent teeth showing one residual pocket with probing depth (PD) ≥5, without mobility and without furcation involvement.
排除标准
- •full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) >20%
- •inadequate restorative therapy or malocclusion
- •uncontrolled systemic disease
- •immunosuppressive therapy or therapy with corticosteroid or with bisphosphonates
- •inflammatory and autoimmune diseases of the oral cavity
- •history of malignancy, radiation therapy or chemotherapy for malignancy in the last 5 years
- •insulin-dependent diabetes;
- •smoking (> 10 cigarettes per day)
- •drug and alcohol abuse
- •pregnant or lactating.
结局指标
主要结局
Pocket depth
时间窗: 12 months
Clinical evaluations were performed by a blind calibrated examiner, different from the investigator who performed the treatment. At baseline (visit 1) and at 6 (visit 2), 8(visit 3), 24 (visit 4), 36 (visit 5) and 48 (visit 6) weeks using a periodontal probe
次要结局
未报告次要终点
研究者
Andrea Pilloni MD DDS MS
Chairman Section of Periodontics Director of Master Program in Periodontics
University of Roma La Sapienza