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Effects of Using Miswak in Addition to Oral Hygiene Products in Patients With Gingivitis

2026年7月1日 更新者:Aysegul SARI、Mustafa Kemal University

This pilot study aims to evaluate the effects of miswak use on the oral biological environment by comparing biochemical parameters obtained from saliva and dental plaque samples collected from individuals who use miswak and controls. A total of 36 healthy volunteers will be enrolled in the study, including 18 miswak+rutine oral hygiene products users and 18 rutine oral hygiene products.

Periodontal clinical parameters will be recorded, and saliva and supragingival dental plaque samples will be collected from all participants. The collected samples will be analysed for biomarkers associated with periodontal inflammation and oxidative stress. Interleukin-1 beta (IL-1β), C-reactive protein (CRP), and oxidative stress levels will be measured using biochemical analysis.

The findings of this study are expected to provide preliminary evidence regarding the biological effects of miswak on oral health and contribute to the current understanding of its potential role as an adjunctive oral hygiene tool.

研究概览

研究类型

观察性的

注册 (估计的)

36

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

      • Hatay、土耳其(türkiye)、31000
        • Hatay Mustafa Kemal Üniversitesi
        • 接触:
        • 接触:
    • Hatay
      • Antakya、Hatay、土耳其(türkiye)、31000
        • Hatay Mustafa Kemal University
        • 接触:
        • 接触:
        • 首席研究员:
          • Hasan Burak Sen, DDs

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

取样方法

非概率样本

研究人群

Patients diagnosed with gingivitis who attended the Department of Periodontology and met the eligibility criteria. Eligible participants will be systemic healthy patients with gingivitis who have not received periodontal treatment for 6 months. A total of 36 participants were enrolled and randomly allocated to the intervention and control groups.

描述

Inclusion Criteria:

  • To be in the age range of 18-60 years
  • To have no systemic disease
  • To be diagnosed with gingivitis

Exclusion Criteria:

  • Smoking
  • History of recent periodontal treatment

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

队列和干预

团体/队列
干预/治疗
Test Group: Miswak using
Participants received oral hygiene instructions and used a manual toothbrush twice daily in combination with miswak (Salvadora persica L.) five times daily for one month before periodontal treatment. Clinical periodontal parameters will be recorded, and salivary IL-1β, CRP, and oxidative stress levels will be evaluated at pre-op (4 weeks), baseline (before periodontal treatment), and post-op (6 weeks).
Participants used miswak (Salvadora persica L.) as an adjunct to toothbrushing, five times per day, for one month before periodontal treatment.
Participants used a manual toothbrush twice daily for one month before periodontal treatment.
control group
articipants with gingivitis received oral hygiene instructions and used a manual toothbrush twice daily without miswak. Clinical periodontal parameters will be recorded, and salivary IL-1β, CRP, and oxidative stress levels will be evaluated at pre-op (4 weeks), baseline (before periodontal treatment), and post-op (6 weeks).
Participants used a manual toothbrush twice daily for one month before periodontal treatment.

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
Change in Salivary Interleukin-1 Beta (IL-1β) Levels
大体时间:Pre-op 4 weeks and after 6 weeks
To evaluate the effect of adjunctive miswak use on salivary interleukin-1 beta (IL-1β) levels in patients with gingivitis. Salivary IL-1β concentrations will be measured using enzyme-linked immunosorbent assay (ELISA).
Pre-op 4 weeks and after 6 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in Clinical Periodontal Indices
大体时间:Pre-op 4 weeks and after 6 weeks
To evaluate changes in clinical periodontal parameters, including Plaque Index (PI), Gingival Index (GI), and Bleeding on Probing (BOP) following adjunctive miswak use.
Pre-op 4 weeks and after 6 weeks
Change in Salivary C-Reactive Protein (CRP) Levels
大体时间:Pre-op 4 weeks and after 6 weeks
To evaluate changes in salivary C-reactive protein (CRP) concentrations as a marker of oral inflammatory status following adjunctive miswak use.
Pre-op 4 weeks and after 6 weeks
Change in Salivary Oxidative Stress Levels
大体时间:Pre-op 4 weeks and after 6 weeks
To evaluate changes in salivary oxidative stress levels following adjunctive miswak use using appropriate biochemical assays.
Pre-op 4 weeks and after 6 weeks

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。

调查人员

  • 首席研究员:Hasan Burak Sen, DDs、Hatay Mustafa Kemal Üniversitesi
  • 研究主任:Ayşegül Sari, PhD、Hatay Mustafa Kemal Üniversitesi

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 (估计的)

2026年7月4日

初级完成 (估计的)

2027年7月4日

研究完成 (估计的)

2027年7月4日

研究注册日期

首次提交

2026年7月1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8日

研究记录更新

最后更新发布 (实际的)

2026年7月8日

上次提交的符合 QC 标准的更新

2026年7月1日

最后验证

2026年7月1日

更多信息

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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