Clinical Trial of PeriZone PerioPatch in Subjects With Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in pocket depth (PD)from Baseline
研究概览
简要总结
The purpose of this study is to determine if a topical, adhesive patch (PeriZone PerioPatch) applied to the gums after a deep tooth cleaning (scaling and root planing) reduces the signs of advanced gum disease (chronic periodontitis) more than the deep tooth cleaning alone. Eighty patients with advanced gum disease will be recruited and treated within this clinical trial. Patients will be evaluated for changes in gum measurements over a 12-week period.
详细描述
Objectives: 1) to evaluate the efficacy of PeriZone PerioPatch (FDA approved device, 510K number K103054) in reducing pocket depth (PD) in subjects with moderate to severe chronic periodontitis; and 2) to assess the effect of PeriZone PerioPatch on secondary clinical outcomes associated with chronic periodontitis including bleeding on probing (BOP), clinical attachment level (CAL), Gingival Index (GI) and Plaque Index (PI).
Participants: A total of 80 participants with generalized moderate to severe chronic periodontitis will be recruited for this clinical trial.
Trial Design: This study is a multicenter, randomized, single blind, and controlled design trial with two parallel arms. The 2 arms of the study are:
- Arm A - Scaling and root planing plus PeriZone PerioPatch;
- Arm B - Scaling and root planing alone (control group).
Procedures (methods): After potential patients have been screened, informed consent forms are signed, and patients have completed the remaining screening evaluations, each patient will be randomized to a treatment group. Patients must present with generalized, moderate to severe chronic periodontitis defined as having at least two periodontal pockets measuring 6 mm or more and bleeding on probing (at Baseline).
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
- 否
入选标准
- •Adult males or females 18 years or older
- •Able and willing to follow study procedures and instructions
- •Must have read, understood and signed an informed consent form
- •Present with at least 12 teeth in the functional dentition, excluding third molars
- •Generalized, moderate to severe chronic periodontitis
- •Present with at least two periodontal pockets (on separate teeth) measuring 6 mm or more and that bleed on probing
排除标准
- •Gross oral pathology
- •Chronic treatment (i.e., two weeks or more) with anti-inflammatory medications (steroids or nonsteroidal anti-inflammatory drugs) or any other medications known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporine and coumadin) within one month of the screening examination
- •Antibiotic treatment within 3 month prior to the screening examination
- •History of rheumatic fever, valvular disease, valve replacement or prosthetic joint replacement necessitating antibiotic prophylaxis
- •Active infectious diseases such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
- •Reported allergies to herbal products
- •Taking herbal product supplements
- •Severe unrestored caries or any condition that is likely to require antibiotic treatment over the study
- •Periodontal therapy (quadrant or maintenance scaling and root planing and/or periodontal surgical therapy) within 6 months prior to enrollment.
- •Female patients who report being pregnant or lactating, or female patients who are of childbearing potential and who are not using hormonal, barrier methods of birth control (e.g., oral or parenteral contraceptives, diaphragm plus spermicide, condoms), or abstinence
结局指标
主要结局
Change in pocket depth (PD)from Baseline
时间窗: At 4, 8 and 12 weeks
PD will be measured from the free gingival margin to the base of the pocket and will be recorded in whole millimeters (mm). If a PD reading falls between two millimeter readings, the rule shall be to round down and the lower of the two readings will be recorded. All sites with PD of 5 mm or more will have two PD readings recorded (multiple-pass probing measurements) per examination time point. The average of the two PD readings will be the basis for deciding whether the site qualifies for treatment (average of two PD readings of 6 mm or more) at Baseline and the response to treatment (Weeks 4, 8 and 12).
次要结局
- Change in clinical attachment level (CAL) from Baseline(At 4, 8 and 12 weeks)
- Change in percent bleeding on probing (BOP) from Baseline(At 4, 8 and 12 weeks)
- Change in Gingival Index (GI) from Baseline(At 4, 8 and 12 weeks)
- Change in Plaque Index (PI) from Baseline(At 4, 8 and 12 weeks)