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临床试验/CTRI/2026/04/107841
CTRI/2026/04/107841尚未招募不适用

Comparative evaluation of clinical outcomes and microbial load after one-stage full mouth disinfection with 20% propolis hydroalcoholic rinse and 0.2% chlorhexidine rinse in stage II grade B periodontitis patients: a single-blind randomized controlled trial.

sanskruti kulkarni1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年4月27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
40
试验地点
1

研究概览

简要总结

This randomized single-blind clinical trial aims to compare the effectiveness of 20 percent  propolis hydroalcoholic rinse with the gold-standard 0.2 percent  chlorhexidine rinse when used as part of a one-stage full-mouth disinfection (OSFMD) protocol in Stage II Grade B periodontitis patients.

A total of 40 patients will be randomly assigned into two equal groups (20 each):

  • Test Group: OSFMD using 20 percent propolis hydroalcoholic rinse
  • Control Group: OSFMD using 0.2 percent chlorhexidine rinse

All participants will undergo full-mouth scaling and root planing within 24 hours, followed by mouth rinsing, tongue brushing, and subgingival irrigation with their respective rinses. They will continue using the assigned rinse (2 ml twice daily) for 2 weeks.

The study evaluates clinical outcomes—gingival index, plaque index, modified sulcus bleeding index, probing pocket depth, and clinical attachment level—along with microbial load (colony forming units) at three intervals:

  • Baseline
  • 24 hours
  • 12 weeks

The primary objective is to determine whether propolis performs comparably or better than chlorhexidine in improving periodontal clinical parameters. The secondary objective is to assess differences in microbial load reduction between the two groups.

The study follows simple random sampling, SNOSE allocation concealment, and involves an examiner-blinded assessment. Statistical analysis will be performed using SPSS with significance set at p less than 0.05.

Overall, the study aims to explore whether propolis, a natural agent with antibacterial and anti-inflammatory properties and fewer side effects, can serve as an effective alternative to chlorhexidine in periodontal therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Participants maintaining good oral hygiene after completion of scaling and root planing.
  • Patients diagnosed with stage II grade B periodontitis three or more nonadjacent teeth with pockets more than or equal to 5 mm.

排除标准

  • Patients with chronic diseases such as diabetes mellitus, arthritis, thyroid disorder, etc.
  • Patients who are smokers or using any other tobacco products.
  • Patients who had undergone subgingival instrumentation within 12 months before the baseline examination.
  • Patients with compromised medical conditions which required prophylactic antibiotic coverage Patients who had used antimicrobial agents 4 months before the study.

研究者

发起方
sanskruti kulkarni
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

sanskruti kulkarni

MGVS KBH dental college and hospital,panchvati,nashik

研究点 (1)

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