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临床试验/NCT07404072
NCT07404072进行中(未招募)1 期

Evaluation of Locally Applied Ferulic Acid as Adjunct to Mechanical Debridement in Treatment of Periodontitis (Clinical and Laboratory Study)

Salah Awad Alanazi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年5月16日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
80
试验地点
1
主要终点
Change in Probing Pocket Depth (PPD)

研究概览

简要总结

to clinical evaluation of locally applied Ferulic acid nanoparticles as an adjunct to mechanical debridement in treatment of periodontitis

详细描述

Periodontitis is a complex chronic multifactorial inflammatory disease that impacts the tissues supporting teeth, causing their progressive destruction. It is initiated by bacterial infection, primarily involving Gram-negative anaerobic bacteria that trigger an immune response and production of pro-inflammatory cytokines. These cytokines recruit numerous neutrophils and macrophages to the site of infection resulting in the release of reactive oxygen species (ROS) and thus worsens tissue damage. Additionally, systemic diseases like diabetes mellitus or behaviors like smoking are examples of exacerbating factors .

Periodontitis remains a significant public health issue as it is the main cause of tooth loss and chewing dysfunction. This condition has far-reaching implications, affecting not only an individual's ability to maintain proper nutrition but also their quality of life and self-esteem. The impact of periodontitis extends beyond personal health, creating substantial socioeconomic burdens and escalating medical costs .

Therefore, effective treatment and management of periodontitis are crucial to mitigating these adverse effects and improving overall well-being. Tailored treatment approaches are essential, primarily focused on controlling the patient's infection. Supra- and subgingival instrumentation, commonly referred to as scaling and root planing (SRP), along with diligent home dental care, have an important role in managing the infection in patients diagnosed with periodontitis .

Systemic drugs used as adjuncts to SRP aim to enhance periodontal treatment outcomes by targeting bacterial pathogens or modulating the host immune response. Common systemic adjuncts include antibiotics, such as amoxicillin and metronidazole, which result in improvement in the clinical attachment levels (CAL) and reduction in periodontal probing depth (PPD) in chronic periodontitis patients. However, their prolonged use can lead to antibiotic resistance, gastrointestinal discomfort, and allergic reactions . Additionally, host-modulating agents, like sub-antimicrobial-dose doxycycline (SDD), inhibit matrix metalloproteinases (MMPs), reducing inflammation and tissue breakdown, but may cause photosensitivity or gastrointestinal issues with long-term use . Nonsteroidal anti-inflammatory drugs (NSAIDs) can also decrease bone resorption but are associated with gastrointestinal and cardiovascular side effects . While systemic drugs can augment SRP efficacy, their side effects and the potential for resistance necessitate careful patient selection and judicious use .

Optimizing the effectiveness of pharmacological therapy while minimizing risks and controlling the release of the drug is crucial. That's why a local drug delivery system (LDDS) is recommended in combination with SRP. LDDS shows promise in treating localized infections in various body parts and serves as a valuable tool for adjunctive local pharmacological therapy in periodontal treatment. LDDSs regulate the discharge of locally administered drugs meant to supplement periodontal treatment .

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Patients of both sexes 25-55 y.
  • Patients who are systemically healthy,
  • Patient exhibiting periodontal pocket depths (PD) ≥5mm,
  • Presence of clinical attachment loss (CAL) between 3-4mm,
  • Cooperative individuals capable of adhering to mechanical oral hygiene instructions

排除标准

  • nPatients with sensitivity to the medication used in the study,
  • Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study,
  • Patients with systemic diseases,
  • Pregnant and lactating females,
  • Smokers and tobacco chewers,
  • Patients are not compliant with oral hygiene procedures.

研究组 & 干预措施

Ferulic Acid

Active Comparator

Drug Group

干预措施: Ferulic Acid (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

Scaling only

Other

干预措施: mechanical debridement only (Procedure)

Healthy

No Intervention

结局指标

主要结局

Change in Probing Pocket Depth (PPD)

时间窗: Baseline and 3 months after treatment

Assessment of changes in probing pocket depth at selected periodontal sites to evaluate the clinical effectiveness of locally applied ferulic acid as an adjunct to mechanical debridement in patients with periodontitis.

Change in Clinical Attachment Loss (CAL)

时间窗: Baseline and 3 months after treatment

Evaluation of changes in clinical attachment loss to determine periodontal tissue response following adjunctive treatment with locally applied ferulic acid.

次要结局

  • Change in Gingival Index (GI)(Baseline and 3 months after treatment)
  • Change in Plaque Index (PI)(Baseline and 3 months after treatment)

研究者

发起方
Salah Awad Alanazi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Salah Awad Alanazi

principle investigator

Mansoura University

研究点 (1)

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