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Non-surgical Treatment of Peri-implant Pockets With H42 (H42)

2026年9月28日 更新者：Bioteck S.p.A.

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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

56

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 西班牙
      • Seville、西班牙、41009
        • 招聘中
        • Faculty of Dentistry, University of Seville
        • 接触：
          • Guillermo Machuca-Portillo, MD
          • 电话号码：+34 954481128
          • 邮箱：gmachuca@us.es

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adult patients diagnosed with peri-implantitis and treated at the Department of Stomatology, Faculty of Dentistry, University of Seville, Spain. Participants are recruited from patients seeking care at the university dental clinic and are allocated to the study groups according to the study protocol and predefined inclusion and exclusion criteria. The study evaluates the adjunctive use of H42 hydrogel in the non-surgical treatment of peri-implantitis using a case-control design.

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：CASE_CONTROL
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
H42 treated group

28 patients treated with ultrasonic treatment and manual curettes + H42®
Control group

28 patients only with ultrasonic treatment and manual curettes

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pocket Probing Depth (PPD)
大体时间：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
At 1 month and 3 months in comparison with the baseline value
Plaque Index (PI)
大体时间：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)
At 1 month and 3 months in comparison with the baseline
Degree of inflammation
大体时间：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
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
NRS scale
大体时间：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)
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Absence of infection
大体时间：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.
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up

次要结果测量

结果测量
措施说明
大体时间
Tissue assessment
大体时间：Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up

Color, suppuration, granulation tissue, bleeding on palpation and incision margins on a five-point scale: 1 is very poor, 2 is poor, 3 is good, 4 is very good, and 5 is excellent
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Radiographic image (x-ray)
大体时间：Baseline and 3 months follow-up

Periapical radiographs were taken using the parallel long cone technique using a customized film-holder device and a bite block. - Bone level (BL): distance (mm) between the implant shoulder and the base of the defect.
Baseline and 3 months follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bioteck S.p.A.

合作者

University of Seville

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月3日

初级完成 (估计的)

2027年9月30日

研究完成 (估计的)

2027年9月30日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年7月1日

首次发布 (实际的)

2026年7月2日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 250423_H42_general

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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