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临床试验/CTRI/2024/08/072097
CTRI/2024/08/072097尚未招募不适用

Comparing The Anti-Plaque And Anti-Gingivitis Efficacy Of Moringa Oleifera Mouthwash To Chlorhexidine And Saltwater Concentration In Treating Gingivitis: A Randomized Controlled Clinical Trial

Dr Snigdha Kandukuri1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
1. anti plaque effect

研究概览

简要总结

The study will be a double-blinded, parallel-designed randomized controlled trial will be conducted in the Department of Periodontics and Oral Implantology at A.M.E’s Dental College and Hospital, Raichur, Karnataka. The study population will consist of undergraduates aged 18-25 years enrolled at A.M.E’s Dental College and Hospital, Raichur, Karnataka. The study will include three groups (A, B, C), each comprising 12 participants selected randomly through a simple lottery method as follows: Group A (N=12) - Moringa oleifera mouthwash, Group B (N=12) - Chlorhexidine mouthwash, and Group C (N=12) - Saline water concentration. An impartial individual will be responsible for conducting the allocation and product coding. All 36 participants will be instructed to use a soft toothbrush with toothpaste and practice a sulcular brushing technique for optimal oral care. The study will adhere to a double-blind design, ensuring that both examiners and participants remain unaware of the mouth rinses assigned. Participants will use 10 ml of mouthwash for 1 minute, twice daily after brushing their teeth for 2 weeks, with the quantity measured using 10 ml cups. Anti-plaque and Anti-Gingivitis Efficacy of mouthwashes will be assessed using the OHI-S index (Greene and Vermillion, 1964), the Gingival index (Loe and Silness, 1963), and the Turesky-Gilmore-Glickman 1970 modification of the Quigley-Hein plaque index. Assessments will be conducted at the study’s baseline and after 2 weeks. For plaque inspection, a two-tone dye-disclosing agent will be applied to all tooth surfaces. Gingivitis severity will be evaluated across four scoring units: disto-facial papilla, facial margin, mesial facial papilla, and the entire lingual gingival margin. Additionally, participants will complete a questionnaire regarding any discomfort (burning, itching, dryness, taste disturbance) and tooth discoloration.

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 and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • After taking a detailed medical history and initial clinical Examination, 1.Systemically healthy individuals with previously untreated gingivitis 2.The individuals with ≥ 20 teeth were selected. Clinical parameters for inclusion are : 3.OHI-S Index ( Greene and Vermillion 1964) – 0.
  • 3.0 Score 4.Plaque Index ( Turesky et al Modification of the Quigley Hein (TQHPI) 1962) – ≤ 4 Score 5.Gingival Index (Loe and silness 1963) – 0.1-2.0 Score 6.Probing depth.

排除标准

  • Use of Antibiotics & Anti-inflammatory drugs in the previous 6 months.
  • Individuals with orthodontic appliances or prosthetic appliances that would interfere with evaluation 3)Allergy to any ingredients used in the study.
  • Alcoholism.
  • Smokers or users of tobacco in any form.
  • pregnancy and Lactating females.

结局指标

主要结局

1. anti plaque effect

时间窗: After 2 weeks

2. anti gingivitis effect

时间窗: After 2 weeks

次要结局

  • questionnaire regarding burning, discoloration,dryness,(alteration in taste)

研究者

发起方
Dr Snigdha Kandukuri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Snigdha Kandukuri

AMEs Dental College And Hospital

研究点 (1)

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