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临床试验/CTRI/2024/04/065108
CTRI/2024/04/065108尚未招募2/3 期

Clinical evaluation of the Coconut husk extract as an oral mouthrinse as an adjunct to scaling in Gingivitis patients. A Randomized Control Clinical Trial.

MGV KBH Dental college1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月11日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Plaque Index - Silness and Loe, 1964 (PI)

研究概览

简要总结

Aim - To clinically evaluate the efficacy of Coconut husk extract as an oral mouth-rinse as an adjunct to scaling in the gingivitis patient.

Objective - To evaluate and compare the Plaque Index (PI), Gingival Index (GI), Sulcus Bleeding Index (SBI)  using coconut husk extract and distilled water  as mouth-rinse in gingivitis patients after 8th and 15th days.

Introduction - Gingivitis caused due to infection and biofilm.The interest in the plants with antibacterial and anti-inflammatory activity has increased now days to treat various dental diseases as consequences of current problems associated with the conventional agents. Coconut husks have been used for maintaining oral hygiene for many years, but there is no scientific evidence for the beneficial effects of this plant material, with respect to antimicrobial properties against common cariogenic bacteria. The phytochemical screening of C. nucifera has reported that this plant material is rich in alkaloids, flavonoids, catechins, and epicatechin, together with condensed tannins, which confer on it potent antimicrobial properties in cariogenic bacteria.

Materials & Methods - 30 patients with biofilm induced gingivitis were divided into 2 groups. Group 1 – coconut husk extract mouth-rinse, Group 2 – distilled water mouth-rinse (placebo). The mouthwash was prescribed after scaling for 15 days. Patients were instructed to use 15ml of mouth-rinse at a time for 2 times daily. Parameters evaluated were Plaque Index, Gingival Index, and Sulcus Bleeding Index at baseline, 8 and 15th day.

Results - Coconut husk extract showed significant reduction  Plaque Index, Gingival Index, and Sulcus Bleeding Index at 8 and 15th day  as compared to placebo.

Conclusion - Coconut husk extract mouth-rinse can be used as an adjunct to scaling in Biofilm Induced Gingivitis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients with age group between 18-40 years Patient with Dental biofilm induced gingivitis.
  • Patients with natural 20 functional teeth.

排除标准

  • Patients who are medically compromised such as diabetic, Immunocompromised or bleeding disorder.
  • Patients with smoking habit.
  • Pregnant or lactating women.
  • Patients who had received any chemotherapeutic mouth rinse or oral irrigation during past 6 months.

结局指标

主要结局

Plaque Index - Silness and Loe, 1964 (PI)

时间窗: baseline, 8th day, 15th day

Gingival Index - Loe and Silness; 1963 (GI)

时间窗: baseline, 8th day, 15th day

Sulcus Bleeding Index – Muhlemann H.R and Son, 1997

时间窗: baseline, 8th day, 15th day

次要结局

  • Not applicable(Not applicable)

研究者

发起方
MGV KBH Dental college
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Tejashree Agawane

MGVs KBH Dental college and hospital

研究点 (1)

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