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临床试验/NCT06324474
NCT06324474尚未招募不适用

Clinical and Immunological Evaluation of Hyaluronic Acid Topical Application in Non-surgical Treatment of Periodontitis

Sana'a University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
Changes in Plaque Index

研究概览

简要总结

To evaluate the immunological effectiveness of Hyaluronic acid as adjunction treatment to scaling and root planning and scaling and root planning alone.

Comparison between clinical measurement before and after treatment. Evaluate the level of IGF-1 in treated site as immunological marker if periodontal regeneration.

详细描述

Periodontal tissue represents a unique system, where the epithelial, non- mineralized, and mineralized connective tissues exist in harmony. This integrity is essential in providing an effective barrier against microbial invasion and preventing the destruction of underlying periodontal tissues by bacterial toxins and enzymes. However; it may lose during chronic inflammation associated with periodontal disease leading to detrimental effects upon the extracellular matrix components of underlying periodontal tissues, including collagens, proteoglycans, and glycosaminoglycans.

Periodontitis is a chronic multifactorial inflammatory disease associated with plaque biofilms and characterized by progressive destruction of the tooth- supporting apparatus. It is considered as an inflammatory condition of the periodontium, which includes an immune response and results in loss of supporting tissues of the teeth. It may affect the general health; a combination of mechanical and chemical treatment provides a good recovery. The etiology for this disease is the accumulation of bacterial plaque on the tooth surface that leads to marginal tissue inflammation, known as gingivitis which is reversable condition that may develop to periodontitis if not treated. ( A new periodontitis scheme has been adopted in which forms of disease previously recognized as 'chronic' or 'aggressive' are now grouped under a single category 'periodontitis' and are further characterized based on a multi-dimensional staging and grading system. Staging is largely dependent upon the severity of disease at presentation as well as on the complexity of disease management, while grading provides supplemental information about biological feature of the disease.

However, the final success rate of the treatment depends on the status and maintenance of oral hygiene. Signs and symptoms of periodontitis may include redness, swelling bleeding of gum, loss of attachment, halitosis and persistent metallic taste in the mouth.

Antibiotics are mandatory in some cases, systemic antibiotics somewhat are effective, no single antibiotic at concentrations achieved in body fluids inhibits all putative periodontal pathogens, indeed a combination of antibiotics may be necessary to eliminate all putative pathogen from some periodontal pockets. ( Topical application has the advantage that antibiotic agents are directed to their specific target areas; reduced drug dosage, increased drug concentration, and reduced side effects can be benefits of topical application. Unfortunately, some antibiotics when used topically induce superinfection and hypersensitivity reaction.

Hyaluronic acid (HA) is an indispensable component of intact, healthy gingiva, and oral mucosal tissue. It has many properties that make it ideal molecule for assisting wound healing by inducing early granulation tissue formation, inhibiting inflammation, promoting epithelial turnover, and also connective tissue angiogenesis. It has many important physiological and biological functions and plays a vital role in the functioning of extracellular matrix including those of periodontium.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy.
  • at least 20 teeth and suffers from moderate <7mm to severe. >8mm.periodontitis with probing depth >5m and in the contralateral side.
  • ability to attend to the clinic in a regular manner.

排除标准

  • allergy to HA.
  • Chronic disease.
  • orthodontic treatment.
  • Qat chewer and smokers.
  • antibiotic in previous 3 months.
  • supplements and mouthwash.

研究组 & 干预措施

scaling and root planning with Hyaluronic acid application

Experimental

patients will receive Hyaluronic acid topical gel after scaling and root planning at first week and receive the gel after one week

干预措施: Hyaluronic acid (Drug)

scaling and root planning with Hyaluronic acid application

Experimental

patients will receive Hyaluronic acid topical gel after scaling and root planning at first week and receive the gel after one week

干预措施: scaling and root planning (Behavioral)

scaling and root planning only

Experimental

patients will receive scaling and root planning only

干预措施: scaling and root planning (Behavioral)

结局指标

主要结局

Changes in Plaque Index

时间窗: From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"

ranges from 0 to 3 score, where increasing in number indicates the worst case.

Changes in Papillary Bleeding Index.

时间窗: From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"

Ranges from 0 to 4 score, where increasing in number indicates the worst case

Changes in Gingival Index

时间窗: From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"

Ranges from 0 to 3 stages, where increasing in number indicates the worst case.

Changes in IGF-1

时间窗: From baseline to 12th weeks post intervention "changes from baseline to 12th week

Through gingival cervical fluid serum collection

Periodontal Probing Depth

时间窗: From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"

distance from the gingival margin to the base of the pocket

Clinical attachment loss

时间窗: From baseline to 12th weeks post intervention "changes from baseline to 12th week

Distance from cemento-enamel junction to the base of pocket

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

ghada almuqayad

Principal Investigator,

Sana'a University

研究点 (1)

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