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临床试验/NCT05005767
NCT05005767Unknown2 期

The Adjunctive Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis: Clinical and Microbiological Study.

Tanta University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
2 期
入组人数
20
试验地点
2
主要终点
bleeding on probing

研究概览

简要总结

This study will evaluate the effect of the subgingival application of Frankincense extract gel as an adjunct to scaling and root planning (SRP) in chronic periodontitis.

详细描述

: twenty patients will be randomly selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days. Clinical measurements included pocket depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). Real-time PCR was carried out to determine the effect of the treatment on Porphyromonas gingivalis (Pg). Clinical measurements and Plaque samples for PCR were recorded at baseline (before treatment), one, and three months after 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
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy patients were selected
  • patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
  • Patients should demonstrate their ability to maintain good oral hygiene

排除标准

  • Smokers and pregnant patients.
  • Medically compromised patients and systemic conditions precluding periodontal surgery.

结局指标

主要结局

bleeding on probing

时间窗: 3 month

bleeding on probingwill be recorded at 3 months at the site to be treated

clinical attachment level

时间窗: 3 month

clinical attachment level will be recorded at 3 months at the site to be treated

probing pocket depth

时间窗: 3 month

probing pocket depth will be recorded at 3 month at the site to be treated

PCR for Porphyromonas gingivalis count

时间窗: 3 month

PCR for Porphyromonas gingivalis count be recorded at 3 months at the site to be treated

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

Doaa Ahmed Yousef

lecturer at Periodontology, oral medicine, diagnosis and radiology department

Tanta University

研究点 (2)

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