Effect of Enamel Matrix Derivative in the Non-surgical Treatment of Periodontal Maintenance Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Periodontal probing depth (PPD)
研究概览
简要总结
The aim of the study is to investigate the effect of enamel matrix derivative in addition to scaling and root planing in comparison to scaling and root planing only in periodontitis patients that have already undergone initial periodontal therapy and are in periodontal maintenance.
详细描述
Enamel matrix derivative (EMD) have already been widely applied as a regenerative bio-modulator in periodontal surgery and have been demonstrated to enhance periodontal regeneration. Recently, also its flapless, non-surgical application has been shown to have beneficial effects when applied during initial therapy of periodontitis.
The present study is designed as a single-blinded randomized controlled clinical trial. We plan to include a total of 50 periodontitis patients that have already undergone initial periodontal therapy, but still show remaining sites with increased periodontal probing depth (PPD). Patients will be randomly allocated at a 1:1 ratio to either scaling and root planing (SRP) in combination with EMD application into the affected pockets (test group, n=25) or to SRP only (control group, n=25). Before treatment, as well as after 3, 6 and 12 months, we plan to assess site-specific periodontal parameters as well as whole-mouth oral hygiene indices. Furthermore, we intend to evaluate gingival crevicular fluid, as well as parameters representing periodontal disease activity.
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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontitis stage III
- •Patients that have completed initial periodontal therapy, and have remaining periodontal pockets of ≥6mm up to 9mm PPD
- •Given written informed consent form for participation in the study
排除标准
- •Systemic antibiotics within the previous 3 months
- •Pregnant or breastfeeding women
- •Any current or past clinically significant pathology/disease (comorbidity) that, in the opinion of the periodontists, might confound the results or poses an additional risk to the subject during participation in the study, such as renal insufficiency, malignancy, rheumatoid osteoarthritis, human immunodeficiency syndrome.
- •Patients with at least one tooth of mobility grade 0 or 1 and/or furcation involvement grade 0 or I according to Hamp
结局指标
主要结局
Periodontal probing depth (PPD)
时间窗: After 12 months
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
次要结局
- CAL (mm)(At baseline, after 3, 6 and 12 months)
- Periodontal bacteria(At baseline, after 3, 6 and 12 months)
- PESA, PISA (mm2)(At baseline, after 3, 6 and 12 months)
- API, PBI (%)(At baseline, after 3, 6 and 12 months)
- GCF markers for periodontal regeneration(At baseline, after 3, 6 and 12 months)
研究者
Christian Wehner, DMD
Dr.med.dent.
Medical University of Vienna