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临床试验/NCT06050174
NCT06050174已完成2 期

Efficacy of Locally Delivered Azadirachta Indica (Neem) Extract as an Adjunct to Non-Surgical Periodontal Management

Ain Shams University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
32
试验地点
1
主要终点
clinical score

研究概览

简要总结

Azadirachta-Indica has various therapeutic activities such as antiseptic, antiulcer, astringent, superior antiviral and for cleaning the teeth in various dental diseases in vitro and vivo. It also purifies blood, removes toxins from the body and neutralizes free radicals. Due to its therapeutic effects, ease of availability of neem, being cost effective and its safety with no adverse reactions, Azadirachta-Indica has been selected for this study as a local drug delivery in the gel form to be placed in periodontal pockets as an adjunct to non-surgical periodontal debridement for the management of localized periodontitis.

详细描述

Total number of thirty-two (32) periodontitis patients including both males and females will be included in the study.

To assess the effect of neem gel on the clinical parameters of patients with localized periodontitis t-test or an equivalent non-parametric test will be used for comparison of Intervention group (neem extract gel) and Control group (non-surgical periodontal debridement). At first preoperative periapical radiographs will be taken for assessment of bone level. The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education.

Baseline assessment will be done following phase I therapy by 2 weeks by full mouth periodontal charting and samples from gingival crevicular fluid will be taken using a sterile perio-paper inserted into the deepest periodontal pocket with horizontal bone loss. AzadirachtaIndica Extract Gel will be applied in the deepest pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks. Follow up of the patients will be done after 3 months after phase I therapy with evaluation of the clinical parameters. The patients will be instructed to brush their teeth 3 times per day during the treatment period using a soft tooth brush together with regular flossing of teeth. A brochure containing written oral hygiene instructions will be given to the patients.

The clinical parameters will be measured two times during the study, the first time at the baseline after two weeks of full mouth debridement and the second time is after baseline by 3 months.

GCF sampling will be done just before neem gel application. Mean values of each parameter will be calculated per patient and per group as well as parameters at the deepest pocket site.

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
None

入排标准

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

入选标准

  • Both males and females will be included in the age group of 20-55 years old.
  • Patients diagnosed to have (Stage II or Stage III) periodontitis; (3-6 mm CAL, pocket depth ≤ 7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis).
  • Patients free from systemic diseases according to the modified Burkett's health history questionnaire.
  • Patients who can follow and maintain oral hygiene instructions.
  • Patients who didn't perform any periodontal therapy in the last 6 months.

排除标准

  • Pregnant ladies or lactating mothers.
  • Patients with history of allergy against one of the components of neem.
  • Asthmatic patients

研究组 & 干预措施

Azadirachta Indica

Experimental

Azadirachta Indica (neem) gel are locally delivered to deepest part of the periodontal pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks.

干预措施: Azadirachta Indica (Drug)

Azadirachta Indica

Experimental

Azadirachta Indica (neem) gel are locally delivered to deepest part of the periodontal pocket by syringe with blunted tip gently and removed slowly in order not to harm the tissue for group 1 patients after phase 1 therapy by two weeks.

干预措施: Non Surgical Periodontal Therapy (Procedure)

Non Surgical Periodontal Therapy

Placebo Comparator

The patients will receive full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes with oral hygiene instructions and education.

干预措施: Non Surgical Periodontal Therapy (Procedure)

结局指标

主要结局

clinical score

时间窗: change from baseline at 3 months

Measuring plaque index, Modified sulcus bleeding index, Probing depth, 4. Clinical attachment level.

次要结局

  • Tumor Necrosis Factor alpha(change from baseline at 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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