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A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid With 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on Active Periodontal Status and Surface Roughness and Biocompatibility

2026年6月2日 更新者:Marwa Helal、Cairo University

A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid With 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on Active Periodontal Status and Surface Roughness and Biocompatibility (A Randomized Controlled Clinical Trial)

A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid with 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on active Periodontal status and Surface Roughness and biocompatibility (A Randomized Controlled clinical Trial).

研究概览

详细说明

This randomized clinical trial evaluates their effects regarding periodontal assessment, including

  1. Clinical attachment loss (CAL)
  2. Plaque Index (PI)
  3. Gingival Index (GI)
  4. Bleeding on probing (BOP)
  5. using digital scanner then a profilometer to measure surface roughness

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

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

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Systemic healthy patients

    • Patients aged > 25 years
    • Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease (Papapanou et al. 2017).
    • Patients with interdental clinical attachment loss (CAL) of 3-4 mm
    • No history of previous periodontal therapy.
    • No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs.
    • No previous periodontal surgery at involved sites.
    • Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
    • Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months
    • Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders
    • Absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus.

Exclusion Criteria:

  • Smoking habits

    • Pregnant and lactating mothers
    • Patients who have been received periodontal surgery in the study area during the last 6 months

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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention Study Group
Group (A and B): 3D Printed Dental Restoration with hyaluronic acid and Milled CAD CAM Dental Restoration with hyaluronic acid.
  • Tooth preparation will be performed following standardized prosthodontic guidelines
  • 1.5-2 mm occlusal reduction
  • 1-1.2 mm axial reduction
  • Chamfer finish line
  • Digital impressions will be obtained using an intraoral scanner.
  • CAD/CAM Milled and 3D printed Provisionals will be fabricated
  • Once the study restorations were finished, the intraoral optical impression was made.

While control both procedures will be done but without using hyaluronic acid

有源比较器:Control Group
Group (C and D): 3D Printed Dental Restoration without hyaluronic acid and Milled CAD CAM Dental Restoration without hyaluronic acid
  • Tooth preparation will be performed following standardized prosthodontic guidelines
  • 1.5-2 mm occlusal reduction
  • 1-1.2 mm axial reduction
  • Chamfer finish line
  • Digital impressions will be obtained using an intraoral scanner.
  • CAD/CAM Milled and 3D printed Provisionals will be fabricated
  • Once the study restorations were finished, the intraoral optical impression was made.

While control both procedures will be done but without using hyaluronic acid

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
Clinical Attachment Loss (CAL)
大体时间:Day 0 - month 3
• will be measured clinically using UNC periodontal probe from cemento enamel junction to depth of periodontal pocket
Day 0 - month 3
bleeding on probing (BOP)
大体时间:Day 0 - month 3

will be measured clinically using UNC periodontal probe. Count the bleeding points and divided them by the total number of patients' teeth in the oral cavity and multiply by 100 to make the percent.

localized less than 30% and generalized greater than or equal 30%

Day 0 - month 3
Plaque index (PI)
大体时间:Day 0 - month 3

plaque index

This clinical method assesses the thickness of plaque specifically at the cervical margin (gumline).

The Scoring Scale (0 to 3):

0: No plaque in the gingival area.

  1. A film of plaque visible only by running a probe across the tooth surface or after using a disclosing solution.
  2. Moderate accumulation of plaque visible to the naked eye along the gumline.
  3. Abundance of soft matter within the pocket or along the gumline
Day 0 - month 3

次要结果测量

结果测量
措施说明
大体时间
biocompatibility
大体时间:Day 0 - month 3
• will be calculated through measuring Bop, gingival index, and plaque index as mentioned before.
Day 0 - month 3
Surface roughness
大体时间:Day 0 - month 3
will be measured using a surface roughness measuring instrument (or profilometer) is a precision device used to evaluate the texture of a material by measuring microscopic peaks and valleys. They are essential for quality control in manufacturing to ensure components meet strict friction, wear, and coating adhesion standards.
Day 0 - month 3

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。

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 (估计的)

2026年6月1日

初级完成 (估计的)

2026年6月1日

研究完成 (估计的)

2026年8月1日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年6月2日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 15022026

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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