Treatment of Periodontal and Peri-Implant Pockets With a Novel Collagen Hydrogel: A Multicenter Retrospective Study on the Clinical Use of the H42 Medical Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Change from Baseline in Clinical Attachment Level (CAL) at 30 and 90 days
研究概览
简要总结
A retrospective, observational, non-profit study designed to evaluate the use of the H42 medical device in patients with periodontitis or peri-implantitis. The study included adult subjects aged 25 to 65 years with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm and 1-5 defects, treated with H42® according to standard clinical practice.
The primary outcome involved comparing the periodontal parameters-Periodontal Pocket Depth (PPD), Plaque Index (PI), Clinical Attachment Level (CAL), and Sulcus Bleeding Index (SBI)-before the application of H42 (baseline) and at follow-up visits after 30 and 90 days.
The secondary outcomes, on the other hand, assessed soft tissue healing, pain levels via Numeric Rating Scale (NRS 0-10), recurrence of infection, and any unexpected side effects observed. These parameters were assessed at 7, 14, 21, 30, and 90 days after the use of H42.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adults aged 25 years ≤ age ≤ 65 years.
- •Subjects with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm.
- •Subjects with 1-5 defects.
- •Subjects willing to provide signed informed consent to participate in the clinical study.
排除标准
- •Use of aspirin and/or antiplatelet agents one week prior to treatment.
- •Smokers (≥10 cigarettes per day).
- •Use of concomitant treatments or procedures aimed at improving gum health within the last six months prior to enrollment in the clinical trial, such as treatments with HA gel, filler injections, or surgical procedures.
- •Subjects with infectious diseases, including infection with the herpes simplex virus, active hepatitis, or the human immunodeficiency virus.
- •Subjects who have undergone cosmetic dental surgery within the previous 12 months.
研究组 & 干预措施
Periodontitis group
28 patients affected by periodontitis ranging from stage II to IV, classified according to the 2018 EFP/AAP new classification of Periodontal and Peri-Implant Diseases and Conditions.
Peri-implantitis group
23 patients affected by peri-implantitis with a severity grade classified according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
结局指标
主要结局
Change from Baseline in Clinical Attachment Level (CAL) at 30 and 90 days
时间窗: Baseline before H42 treatment; 30 days and 90 days after H42 treatment.
CAL will be evaluated to assess periodontal tissue regeneration. Measurement is calculated using the formula: CAL = PPD - (CEJ to FGM distance), where PPD is Probing Pocket Depth, CEJ is Cemento-Enamel Junction, and FGM is Free Gingival Margin. Measurements will be taken in millimeters (mm).
Change from Baseline in Sulcus Bleeding Index (SBI) at 30 ad 90 days
时间窗: Baseline before H42 treatment; 30 days and 90 days after H42 treatment.
SBI evaluated as ordinal variable with a scale from 0 to 5, where: 0 = gingiva of normal texture, color, no bleeding; 1 = gingiva apparently normal, bleeding on probing; 2 = bleeding on probing, color change, no edema; 3 = bleeding on probing, color change, slight edema; 4 = either bleeding on probing, color change, obvious edema; 5 = spontaneous bleeding on probing, color change.
Change from Baseline in Periodontal Pocket Depth (PPD) at 30 and 90 days
时间窗: Baseline before H42 treatment; 30 days and 90 days after H42 treatment.
PPD defined as the distance, measured in millimeters (mm) from the gingival margin to the bottom of the gingival sulcus/pocket.
Change from Baseline in Plaque Index (PI) at 30 and 90 days
时间窗: Baseline before H42 treatment; 30 days and 90 days after H42 treatment.
PI will be used to evaluate the presence and thickness of plaque at the gingival margin. Scoring is based on the Silness and Löe Plaque Index criteria on a scale from 0 to 3, where: 0 = no plaque; 1 = a film of plaque adhering to the free gingival margin and adjacent area of the tooth, recognized only by running a probe across the tooth surface; 2 = moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, visible to the naked eye; 3 = abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Higher scores indicate greater plaque accumulation. The final value represents the patient's average score across all examined surfaces.
次要结局
- Change from Baseline in Patient-Reported Pain Score at five predefined follow-up timepoint(Baseline before H42 treatment and at 7, 14, 21, 30, and 90 days after the use of H42.)
- Change from baseline in inflammation grade at five predefined follow-up timepoints(Baseline before H42 treatment and at 7, 14, 21, 30, and 90 days after the use of H42.)
- Change from Baseline in soft tissue healing at five predefined follow-up timepoint(Baseline before H42 treatment and at 7, 14, 21, 30, and 90 days after the use of H42.)
研究者
Giacomo Tarquini
Doctor of Dental Surgery
Studio Odontoiatrico Dott. G. Tarquini