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临床试验/NCT03043066
NCT03043066已完成不适用

The Effect of Non-surgical Periodontal Therapy With or Without Systemic Administration of Amoxicillin and Metronidazole on Serum Levels of TRAP-5b in Patients With Generalized Chronic Periodontitis - A Comparative Clinical Study

Meenakshi Ammal Dental College and Hospital0 个研究点目标入组 30 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Serum levels of TRAP-5b

研究概览

简要总结

To compare the effect of non-surgical periodontal therapy with or without systemic administration of amoxicillin and metronidazole on the concentration of serum levels of TRAP-5b in patients with generalized chronic periodontitis.

详细描述

30 Chronic periodontitis subjects were divided into two groups- group A underwent scaling and root planing and group B underwent scaling and root planing with systemic administration of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days.

Periodontal parameters probing pocket depth and clinical attachment level were measured at baseline and at 3rd month. Serum TRAP-5b levels were also measured at baseline, 1 month and at 3rd month.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of atleast 20 teeth
  • more than 30% of sites with clinical attachment loss of ≥ 5 mm
  • non-smokers
  • no previous history of periodontal therapy

排除标准

  • systemic diseases
  • under antibiotics or anti-inflammatory drugs within previous 3 months
  • pregnant and lactating women
  • allergic to antibiotics

研究组 & 干预措施

Group A -control group

Placebo Comparator

15 subjects underwent scaling and root planing

干预措施: Scaling and root planing (Procedure)

Group B-Interventional group

Active Comparator

15 subjects underwent scaling and root planing along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days

干预措施: scaling and root planing along with antibiotic intervention (Drug)

结局指标

主要结局

Serum levels of TRAP-5b

时间窗: Baseline and 3 months

Concentration of serum levels of TRAP-5b was assessed at baseline and at 3rd month using ELISA method.

次要结局

  • Clinical attachment level(Baseline and 3 months)
  • Probing pocket depth(Baseline and 3 months)

研究者

发起方
Meenakshi Ammal Dental College and Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Jaideep Mahendra

Professor

Meenakshi Ammal Dental College and Hospital

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