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临床试验/CTRI/2025/07/091823
CTRI/2025/07/091823尚未招募不适用

Efficiency and Patient Compliance of Conventional Floss Over Unifloss in the Management of Gingival Health

Dr.N.T.R University of Health Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月11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
60
试验地点
1
主要终点
levels of plaque are calculated using plaque index

研究概览

简要总结

Dental plaque is a structured biofilm harboring complex microbial communities and serves as a primary etiological factor in the progression of gingival and periodontal diseases.  Throughout history, innumerous devices and methodologies bearing different levels of efficacy have been introduced over the counter for promoting gingival health. Substantial clinical evidence shows the importance of mechanical debridement through daily tooth brushing in disrupting the plaque biofilm. However, it has been reported that tooth brushing alone is inadequate for effective plaque removal in the interdental embrasure spaces and hence the need for other adjunctive aids such as dental floss is emphasized. Over the years, the usage of dental floss as an adjunctive interdental aid has not been very successful due to its technique sensitivity, time consumption as well as lack of patient motivation and cooperation.

The purpose of the study is to assess the effect of dental floss as an adjunctive interdental aid in promoting gingival health and to compare the effect of conventional flossing technique versus floss with holder on patient compliance.

The above study may be helpful to add to the existing evidence that floss is an important adjunctive interdental aid to reduce the accumulation of plaque biofilm and gingival inflammation and thus promote gingival health.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Individuals with OHI-S score good will be considered for the study, Type I embrasures, No missing teeth except for third molars, Participants who have not used floss for interdental cleaning along with tooth brushing, Individuals who have not undergone professional oral prophylaxis in the last two months, Overall good general health, Individuals who are willing to participate and are available for the 2 weeks duration of the study.

排除标准

  • Individuals with chronic or systemic illnesses, Malaligned teeth – crowding, Pregnant women and lactating mothers, Smokers, Subjects who received oral prophylaxis in the duration of last two months prior to the study, History of extensive subgingival restorations or overhanging restorations, crowns or partial dentures.

结局指标

主要结局

levels of plaque are calculated using plaque index

时间窗: Baseline and 2 weeks

次要结局

  • Gingival inflammation will be assessed using gingival bleeding index(Baseline and 2 weeks)
  • Gingival Trauma will be assessed using Carter Hanson scoring(At 2 weeks)
  • Patient compliance using post trial questionnaire(At 2 weeks)

研究者

发起方
Dr.N.T.R University of Health Sciences
申办方类型
Other [Affiliated University]
责任方
Principal Investigator
主要研究者

Rupali Singh

GITAM Dental College

研究点 (1)

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