Non-surgical Treatment of Peri-implant Pockets With H42
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pocket Probing Depth (PPD)
研究概览
简要总结
This prospective, observational study evaluates the efficacy and safety of H42 non-surgical treatment for peri-implant pockets. The trial involves 56 patients, with 28 subjects receiving the H42 treatment and 28 acting as a control group to monitor soft tissue healing and bone level changes.
Clinical outcomes focus on Pocket Probing Depth (PPD) and Silness and Löe Plaque Index (PI) measured at baseline, 1 month, and 3 months. Gingival inflammation, pain intensity on a 0-10 NRS scale, and absence of infection are monitored at baseline, 7, 14, and 21 days, and at 1 and 3 months. Additionally, a five-point tissue assessment evaluates color, suppuration, granulation tissue, bleeding, and incision margins. Radiographic analysis at baseline and 3 months uses standardized periapical x-rays to measure bone level, intra-bony defect height, width, and angulation. Safety is assessed through the continuous registration of adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women with age ≥ 25 and ≤ 65 years.
- •Subjects affected by peri-implant pockets with probing depth (PD) in the range between 6 to 8 mm.
- •Each subject can have from 1 to 5 defects.
- •Subjects willing to provide signed informed consent to clinical investigation participation.
排除标准
- •Use of aspirin and antiplatelet agents a week before treatment.
- •Subjects smokers ≥ 10 cigarettes per day.
- •Subjects presenting current or previous bleeding disorders.
- •Subjects taking or having indications for anticoagulant therapy.
- •Concomitant treatments or procedures to improve gum health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, and surgery.
- •Subjects suffering from infectious diseases, including herpes simplex infection, active hepatitis, or human immunodeficiency virus.
- •Subjects with dental aesthetic surgery in the preceding 12 months before the clinical investigation enrolment.
结局指标
主要结局
Pocket Probing Depth (PPD)
时间窗: At 1 month and 3 months in comparison with the baseline value
The distance measured from the base of the pocket to the most apical point on the gingival margin, and it will be measured with an electronic Florida probe at controlled pressure
Plaque Index (PI)
时间窗: At 1 month and 3 months in comparison with the baseline
For each tooth, the four-point scale Silness and Löe Plaque Index is used (Score 0: Excellent; 3: poor)
Degree of inflammation
时间窗: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Not inflamed, mild inflamed, Moderately inflamed, Very inflamed
NRS scale
时间窗: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Numeric Rating Scale is a simple, reliable tool used to measure pain intensity on a scale from 0 to 10 (0: no pain; 10: maximum pain)
Absence of infection
时间窗: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Clinical evaluation to assess the absence of infection, specifically defined as the absence of suppuration (pus formation), at the treated site as evaluated by the Investigator.
次要结局
- Tissue assessment(Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up)
- Radiographic image (x-ray)(Baseline and 3 months follow-up)