A Randomized, Parallel Design Study to Assess the Effects of Three Interproximal Cleaning Modalities Versus a Manual Toothbrush Control on Gingivitis and Plaque Following a Period of Home Use

Philips Oral Healthcare1 个研究点分布在 1 个国家目标入组 290 人2014年6月

适应症Gingivitis

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Gingivitis
发起方: Philips Oral Healthcare
入组人数: 290
试验地点: 1
主要终点: Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14
状态: 已完成
最后更新: 10年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.

注册库

clinicaltrials.gov

开始日期

2014年6月

结束日期

2014年7月

最后更新

10年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Philips Oral Healthcare

责任方

Sponsor

入排标准

入选标准

•Be willing and physically able to carry out all study procedures and be available at all times required for participation
•Be able to fully understand and comply with the written and verbal instructions provided
•Provide written Informed Consent
•Be age 18 - 65 years
•Agree to return study materials at the required visits
•Be a non-smoker
•Have a minimum of 20 'scorable' teeth (excluding 3rd molars)
•Have a minimum average plaque score of \> 0.5 per RMNPI scoring with 2-6 hours of plaque accumulation
•Have a Gingival Bleeding Index of -\>1 on at least 10 sites
•Be a regular manual toothbrush user

排除标准

•A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion
•Pregnant or nursing per subject report
•A medical condition requiring antibiotic pre-medication prior to dental appointments
•Diagnosis of xerostomia
•Any oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth
•Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator /Examiner discretion
•Oral surgery within the last 2 months
•Current use of professionally dispensed bleaching products
•A known allergy or sensitivity to products planned for use in this study
•Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study

结局指标

主要结局

Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14

时间窗: 14 days

MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).

次要结局

Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28(28 days)
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14(14 days)
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28(28 days)
Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14(14 days)
Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28(28 days)