ISRCTN32122610进行中（未招募）未知
A clinical evaluation to compare a power toothbrush to a manual toothbrush in the reduction of plaque and gingivitis among a population with fixed orthodontic appliances
Procter & Gamble (United States)0 个研究点目标入组 60 人开始时间: 2022年2月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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 in case of being adolescent) and be given a signed copy of the Informed Consent form
- •2. Have fixed orthodontic appliances in both dental arches
- •3. Be at least 13 years old and typically use a manual toothbrush
- •4. Possess a minimum of 16 natural teeth (excluding third molars) with facial and lingual scorable surfaces
- •5. Have a whole mouth average Baseline TQHPI score of 1.75
- •6. Have a Baseline whole mouth mean LSGI score of at least 1.75 but not more than 2.5
- •7. Be in general good health as determined by the Investigator/designee based on a review/update of their medical history
- •8. Agree not to participate 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 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 -- 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: periodontitis, cancer, or a seizure disorder
- •5. Report to be nursing or pregnant, or intend to become pregnant any time during the course of this study
- •6. Taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks
- •7. Having a dental prophylaxis any time within the previous 4 weeks
- •8. Have any of the following: removable partial dentures, peri/oral piercings, a pacemaker or other implanted device
- •9. Oral/gum surgery within the previous two months
- •10. 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
已完成
不适用
A study to assess the use of an electric tooth brushing kit to reduce dental plaque and gum disease in teenagers undergoing an orthodontic treatmentEvidence of dental plaque and gingivitisOral HealthISRCTN18251395Procter & Gamble (United States)64
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