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临床试验/CTRI/2025/06/089601
CTRI/2025/06/089601尚未招募不适用

Comparative Evaluation Of Water Flosser and Dental Floss in Gingival Health Maintenance- A Randomized Controlled Trial

BACCHU VENKATA SUSHMA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月8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
30
试验地点
1
主要终点
to evaluate the effectiveness of flossing methods in reducing the clinical signs of inflammation in gingivitis patients (gingival bleeding and supragingival plaque).

研究概览

简要总结

Background: Effective plaque control is pivotal in managing and reversing gingival inflammation. While traditional dental floss has been the gold standard for interdental cleaning, its been highly technique sensitive, resulting in patient self-harm if not used in the proper way leading to more periodontal tissue damage. The water flossers have emerged as a modern alternative to manual flossing. This study aimed to compare the impact of water flossing and conventional dental floss on clinical parameters in patients with gingivitis over a one-month period. Method: Thirty healthy, non-smoking adults participated in a four-week clinical study designed as a single-blind, parallel-group trial. The participants were randomly divided into three groups, with each group consisting of 10 individuals. • Group A received a water flosser and a manual toothbrush (WF+MTB). • Group B received dental floss and a manual toothbrush (DF+MTB). • Group C received a manual toothbrush only (MTB). Results: At baseline and 2 weeks, Group B has significantly lower mean plaque index score while at 4 weeks group A has significantly lower plaque index score when compared with other groups. Intra group comparison shows decrease in plaque index scores in Group A(WF+MTB) the difference observed was statistically significant in Group A(WF+MTB). The MSBI values decreased over time for all groups, these changes were not statistically significant. Additionally, there were no statistically significant differences between the groups at any time point. Conclusion: The present study shows that using a water flosser device is easier and more effective than manual flossing for improving gingival health. New products with different mechanism of actions, different delivery methods, or specifications need to be compared. Each product needs to be tested individually and differences between devices should be clinically meaningful. Keywords: Gingivitis, Dental Floss, Water Flosser, Oral Health, Plaque Control

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy gingivitis patients -age group 18-50 years -patient with fair to poor oral hygiene, minimum of 20 scorable teeth excluding 3rd molars -patient who were willing to give informed consent.

排除标准

  • Systemically compromised individuals -patient who are smokers.
  • periodontitis patients -Patient who are not willing to give informed consent.

结局指标

主要结局

to evaluate the effectiveness of flossing methods in reducing the clinical signs of inflammation in gingivitis patients (gingival bleeding and supragingival plaque).

时间窗: baseline,2weeks,4weeks

次要结局

  • 1. To evaluate the efficacy of water flosser on reduction of the gingival inflammation in gingivitis patients.(2. To evaluate the efficacy of water flosser over manual flossing in oral hygiene maintenance)

研究者

发起方
BACCHU VENKATA SUSHMA
申办方类型
Other [SELF FUNDED]
责任方
Principal Investigator
主要研究者

BACCHU VENKATA SUSHMA

Lenora institute of dental sciences

研究点 (1)

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