Powertoothbrushing for Treating Gingivitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in Gingivitis
研究概览
简要总结
In this three-month interventional clinical trial for the treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene.
详细描述
In this single-masked, parallel-armed, interventional clinical trial for treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene. The primary outcome variable is the change from baseline in the Modified Gingival Index at 2, 4 and 12-weeks from Baseline. Secondary outcome variables include change from baseline in bleeding on probing as well as change from baseline in the Turesky Modification of the Quigley-Hein Plaque index measuring overnight plaque formation. There will also be an assessment of single use efficacy in reduction of overnight plaque levels at the baseline visit t
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
examiners will be unaware of which toothbrush has been assigned to each subject
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A subject who meets all the following criteria will be eligible to enroll in this study.
- •Age range 18 - 65 years
- •Routine manual toothbrush user
- •A Subject who agrees to use the assigned toothbrush as the only cleaning device for the study duration, refraining from daily interdental cleaning and/ or antiseptic mouthrinsing.
- •Mild to moderate gingivitis as measured by A. Modified Gingival Index (MGI) average score of at least 1.2, and / or B. Bleeding on Probing (BOP) of at least 20% of all sites but not more than 50% of sites.
- •Probing Pocket Depth (PPD) of 4 mm or lower
- •At least 20 natural teeth - scoreable (crowns or bridgework are non-scoreable).
排除标准
- •Any subject meeting one of the following criteria will not be included in the study.
- •Daily user of interdental cleaning devices, such as floss, floss picks, toothpicks, interdental brush, water flossing device
- •Regular user of antimicrobial mouthrinses within one week of entry into study
- •Professional prophylaxis within one month of entry into the study
- •Use of antibiotics within one month prior to the baseline exam
- •Signs of moderate to severe periodontitis or caries, categorized as PPD of 5 mm of higher and attachment loss of 3 mm or higher
- •Subjects with orthodontic bands and/or dental appliances.
- •Participated in an oral care related study in the last 90 days prior to this study
- •Pregnant or lactating women
- •Patients with a history of significant cardiovascular disease, diabetes, cancer, AIDS, or other organ impairment that would preclude their participation in the study
- •Acute/concurrent illness such as hepatitis, herpes simplex infections, influenza, etc.
- •History of rheumatic fever, cardiovascular valvular disease, artificial joint replacement or kidney or liver disorders
- •Chronic use of steroids; limited use of NSAID's (≤ 325 mg/day)
- •Current Smoker (within the last 3 months)
- •Other medical or dental conditions that would affect the study
- •Inability to commit to all necessary study visits from baseline to 12 weeks
结局指标
主要结局
Change in Gingivitis
时间窗: 12 weeks post-baseline
Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe.
次要结局
未报告次要终点