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临床试验/NCT04851548
NCT04851548Unknown不适用

Evaluate the Effectiveness of Bioactive Hyaluronic Acid in the Treatment of Furcation Involvement

Riyadh Elm University0 个研究点目标入组 18 人开始时间: 2021年9月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
18
主要终点
evaluate the regenerative effect of hyaluronic acid

研究概览

简要总结

the effect Hyaluronic Acid in the Treatment of Furcation Involvement

详细描述

The materials to be used in the study are the following:

  • Hyaluronic acid
  • Cone-beam computed tomography(CBCT) x-ray The patients with Grade II furcation will be divided into two groups. Both groups will have the same number of patients and the same procedure, such as the scaling root planning. However, the control group will use hyaluronic acid and membrane. The placebo group, on the other hand, will use hyaluronic acid without membrane and will use CBCT x-ray. The x-rays will be done at the beginning of the treatment. Then, two monitoring processes will be done. The first monitor will be done after three months. The data will be recorded. Then, after another three months, the patients will undergo an x-ray check again, and the data will be recorded. The goal is only to have the patients exposed to x-ray twice so they would not be compromised to the high dose of radiation. The evaluation to be done for the 3-month interval will only be clinical assessments.

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
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Selected teeth: Permanent first and second molars in the mandible.
  • Furcation dimension: Radiographic and clinical evidence of exhibiting defects due to Grade II furcation with at least 2 millimeters probing depth horizontally and at least 5 millimeters probing depth circumferential.
  • Gender: both males and females.
  • Age range: between 18 and 55 years.
  • Health status: healthy patients non-systemic diseased except controlled diabetic.
  • Compliance: Patients will be willing and able to comply with adequate oral hygiene protocols.

排除标准

  • Patients that received periodontal regenerative therapy within the past 12 months.
  • Patients that are lactating.
  • Pregnant patients.
  • Patients with pulp infection.
  • Patients with trauma resulting from occlusion.
  • Patients with receding gum.
  • Patients with tooth mobility greater than grade II.
  • Patients that will not comply with the hygiene protocols in Phase I therapy.
  • Patients with potential illnesses that can influence the periodontal therapy outcomes.
  • Patients that are taking medications that can interfere with the healing outcomes of the periodontal wound.
  • Patients allergic to any drugs.

结局指标

主要结局

evaluate the regenerative effect of hyaluronic acid

时间窗: 6 months

measurement of the bone gain after the treatment with hyaluronic acid in millimeters

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghady Adnan Alqahtani

periodontic resident

Riyadh Elm University

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