ISRCTN18251395已完成未知
A clinical evaluation to compare a power toothbrush kit to a manual toothbrush in the reduction of plaque and gingivitis among a teenager population with fixed orthodontic appliances
Procter & Gamble (United States)0 个研究点目标入组 64 人开始时间: 2022年7月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Give written informed consent (including her/his guardians) and be given a signed copy of the Informed Consent form
- •2. Have fixed orthodontic appliances in both dental arches
- •3. Aged between 13 and 19 years old and typically use a manual toothbrush
- •4. Minimum of 16 natural teeth (excluding third molars) with facial and lingual scorable surfaces
- •5. Whole mouth average Baseline TQHPI score of 1.75
- •6. Mild to moderate gingivitis with a range of 10% to 70% bleeding sites
- •7. General good health as determined by the Investigator/designee based on a review/update of their medical history
- •8. No participation in any other oral care study for the duration of this study
- •9. Agree to return for scheduled visits and follow the study procedures
- •10. Agree to refrain from the use of any non-study oral hygiene products (Exception: floss if they are currently using) for the duration of the study
- •11. Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study and to report any non-study dentistry received during the course of this study
- •12. Refrain from brushing their teeth or from performing any other oral hygiene procedure anytime within the 12 hours prior to all visits and agree to follow these same restrictions prior to all visits
- •13. Refrain from medicated lozenges, breath mints, eating, drinking*, chewing gum and using tobacco for at least 4 hours prior to this visit and agree to follow these same restrictions prior to all visits. *(Allowed small sips of water up until 45 minutes prior to their appointments.).
排除标准
- •1. A condition requiring the need for antibiotic premedication prior to dental procedures
- •2. Severe periodontal disease, including but not limited to, purulent exudates, generalized mobility, and/or severe recession
- •3. Teeth that are grossly carious, fully crowned, or extensively restored
- •4. Active treatment for the following conditions:
- •4.1. Periodontitis
- •4.2. Cancer
- •4.3. Seizure disorder
- •5. Taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks
- •6. Having dental prophylaxis any time within the previous 4 weeks
- •7. Have any of the following:
- •7.1. Removable partial dentures
- •7.2. Peri/oral piercings
- •7.3. A pacemaker or other implanted device
- •8. Oral/gum surgery within the previous two months
- •9. A disease or condition that could possibly interfere with examination/procedures or with the subject’s safe completion of this study
研究者
相似试验
进行中（未招募）
不适用
A clinical study to assess the efficacy of an electric toothbrush to reduce dental plaque and gum inflammation in persons who have braces to align teethEvidence of dental plaque and gingivitis in an orthodontic populationOral HealthISRCTN32122610Procter & Gamble (United States)60
进行中（未招募）
4 期
Comparison of efficacy between using a power toothbrush and a manual toothbrush by primary caregivers in preschool children: a randomized clinical trialGingival indexPlaque indexGingivitisTCTR20190907004Faculty of Dentistry, Chiang Mai University60
已完成
2 期
Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy ParticipantsDental PlaqueNCT03809910GlaxoSmithKline40
招募中
Unknown
Clinical comparison of tooth brushing with a horizontal scrub method and brushing with a manual U-shaped toothbrush on the reduction of microbial plaque in children aged 5-7 years oldIRCT20231222060492N1Shahre-kord University of Medical Sciences100
已完成
不适用
A clinical study to assess the effectiveness of an electric toothbrush with two different mode settings to reduce dental plaque and gum inflammatioDental plaque and gingivitisOral HealthChronic gingivitisISRCTN82976541Procter & Gamble (United States)42