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临床试验/NCT02154594
NCT02154594已完成4 期

"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.

Tatyasaheb Kore Dental College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Changes from baseline in Plaque index(PI)

研究概览

简要总结

To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in patients with fixed orthodontic appliances.This study is a double blind randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 60 patients in the age group of 15-30 yrs
  • plaque induced gingivitis having fixed orthodontic appliance

排除标准

  • seeking any type of antibacterial mouthwash within four weeks of commencement of study,
  • history of any systemic disease, or past illness,
  • mentally or physically handicapped,
  • history of smoking, tobacco chewing, alcohol consumption,
  • patients with periodontitis, pregnant and lactating women

研究组 & 干预措施

Acacia

Experimental

Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days

干预措施: Acacia catechu (Drug)

Acacia

Experimental

Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days

干预措施: Chlorhexidine gluconate (Drug)

Acacia

Experimental

Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days

干预措施: Distilled water (Other)

Chlorhexidine gluconate

Active Comparator

Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days

干预措施: Acacia catechu (Drug)

Chlorhexidine gluconate

Active Comparator

Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days

干预措施: Chlorhexidine gluconate (Drug)

Chlorhexidine gluconate

Active Comparator

Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days

干预措施: Distilled water (Other)

Distilled water

Placebo Comparator

Rinse with 10 ml distilled water twice daily for 15 days.

干预措施: Acacia catechu (Drug)

Distilled water

Placebo Comparator

Rinse with 10 ml distilled water twice daily for 15 days.

干预措施: Chlorhexidine gluconate (Drug)

Distilled water

Placebo Comparator

Rinse with 10 ml distilled water twice daily for 15 days.

干预措施: Distilled water (Other)

结局指标

主要结局

Changes from baseline in Plaque index(PI)

时间窗: 15 Days

次要结局

  • Changes from baseline in Gingival index(GI)(15 Days)

研究者

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

DR.DHANASHREE RAVINDRA AGARWAL

POST GRADUATE STUDENT IN PERIODONTOLOGY

Tatyasaheb Kore Dental College

研究点 (1)

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