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临床试验/CTRI/2024/09/074027
CTRI/2024/09/074027尚未招募2/3 期

Comparative Evaluation of Efficacy of Herbal Mouthwash (Oralife) with Chlorhexidine Mouthwash (Rexidine SRS) in Generalized Chronic Periodontitis Patients- A Randomized Clinical Trial

Dr Aishwary Patil1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年11月10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
62
试验地点
1
主要终点
1. Plaque Index (P.I.) (Silness and Loe, 1964)

研究概览

简要总结

Aim-To clinically compare and evaluate the efficacy of herbal mouthwash (OralifeTM) with Chlorhexidine Mouthwash(Rexidine® SRS).

Materials and Methods-

This study is an Interventional Prospective Clinical Trial. It is a double-blinded, single-centre, Institution-based study. The patients selected as per the inclusion and exclusion criteria, will be randomly allotted by a computerized automated randomization method into 2 groups, Group A and Group B, and treated as follow.

Group A: Scaling and chlorhexidine (Rexidine® SRS 0.2%) mouthwash

Group B: Scaling and herbal (OralifeTM) mouthwash

The following clinical parameters will be recorded at baseline (post scaling), 1 month post-scaling.

  1. Plaque Index (P.I.) (Silness and Loe, 1964)
  2. Gingival Index (G.I.) (Loe and Silness, 1963)
  3. Probing Pocket Depth (PPD)
  4. Clinical Attachment Loss(CAL)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients in the age group between 20-60 yrs.
  • 2.Patients diagnosed with Chronic Periodontitis.
  • 3.Patients who are non smokers or do not consume tobacco in any other form.
  • 4.Patients with good systemic health.

排除标准

  • 1.Individuals suffering from any systemic diseases.
  • Individuals wearing fixed or removable orthodontic appliances or prosthesis
  • Pregnant and lactating females
  • Individuals taking medications since prolonged duration 5.

结局指标

主要结局

1. Plaque Index (P.I.) (Silness and Loe, 1964)

时间窗: Baseline, 1 month Post treatment

2. Gingival Index (G.I.) (Loe and Silness, 1963)

时间窗: Baseline, 1 month Post treatment

3. Probing Pocket Depth (PPD)

时间窗: Baseline, 1 month Post treatment

次要结局

  • Clinical attachment level(Baseline, 1 month post treatment)

研究者

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

Dr Aishwary Patil

Nair Hospital Dental College

研究点 (1)

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