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临床试验/NCT06201975
NCT06201975尚未招募不适用

Efficacy of Locally Delivered Thyme Honey as a Novel Adjunct to Non-surgical Periodontal Therapy: A Randomized Controlled Clinical Trial

British University In Egypt0 个研究点目标入组 20 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Clinical attachment loss (CAL)

研究概览

简要总结

Periodontal diseases are disease processes involving the periodontium, a term used to describe the supportive apparatus surrounding the tooth, which includes the gingival tissue, alveolar bone, cementum, and periodontal ligament. Thyme honey, as a conventional therapy, might be a novel antioxidant to abate many of the diseases directly or indirectly associated with oxidative stress. To the best of the researchers' knowledge, there are no published studies on the management of periodontitis in using locally delivered Thyme honey.

详细描述

In 2017, the American Academy of Periodontology, in collaboration with the European Federation of Periodontology, devised a new classification of periodontal and peri-implant diseases. In this new classification, periodontitis can be subdivided into three categories, Necrotizing periodontal diseases, Periodontitis, Periodontitis as a manifestation of systemic diseases.

Non-surgical treatment is valuable in mild to moderate periodontitis whereas surgical treatment is useful in progressive cases. Confined drug delivery systems-mouth rinses, irrigating solutions and sustained release devices are used for distribution of antimicrobial agents.

It has been observed that artificial antimicrobial agents and antibiotics are identified to cause antimicrobial resistance. It has also been observed that appearance of formerly rare infections is on the rise perhaps due to the incorrect or prevalent overuse of antimicrobials. Natural phytochemicals have demonstrated to be worthy substitutes to synthetic agents.

It is interesting fact to note that two of the most populated countries in the world China and India, have used herbal medicine for the managing of oral infections, comprising periodontal disease as well for more than a duration of 2000 years.

It has been found that in adults with chronic periodontitis, scaling and root planning along with use of an adjunctive antimicrobial mediator increases patient outcomes over a period of time compared to scaling alone. Modern chemotherapeutic agents display significant efficacy in improving periodontal health but owing to undesirable side effects such as tooth discoloration, taste alteration, and price of these substances, the usage of herbal products has increased lately and could be especially of high benefit to lower socioeconomic populations around the world.

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
Single (Outcomes Assessor)

盲法说明

The clinical outcome assessor (A.A) will not be aware of which treatment will be being administered, thus yielding a single-blind controlled study.

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Both genders, aged above 18 years.
  • All patients must have a periodontal disease.
  • Patients must be able to make reliable decision or communications.

排除标准

  • - Smoking, Alcohol.
  • Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.

结局指标

主要结局

Clinical attachment loss (CAL)

时间窗: 6 weeks

With a periodontal probe, PD and CAL will be measured on six locations of the teeth (mesio-buccal/facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal).

次要结局

  • Bleeding on probing(6 weeks)

研究者

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

Dalia Ghalwash

Professor anf Head of department

British University In Egypt

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