A 4-week clinical study to compare an electrical toothbrush with a new brush head to a manual toothbrush in the reduction of gingivitis and plaque in a pediatric population

Procter & Gamble (United States)0 个研究点目标入组 105 人开始时间: 2021年6月24日最近更新: 2023年11月6日

适应症

试验速览

2023 Results article in https://doi.org/10.1111/ipd.13130 (added 23/10/2023)

•1. Come to the site with a parent or legal guardian which has given written informed consent and received a copy of their consent following the guidelines of the Institutional Review Board of Hadassah University
•2. Aged 3 to 10 years old
•3. In good general health condition as determined by the Investigator/designee based on a review/update of their medical history for participation in the study
•4. Possess a minimum of 16 natural teeth with facial and lingual scorable surfaces
•5. Agree to delay any elective dentistry, including dental prophylaxis and to report any non-study dentistry received for the duration of this study
•6. Have evidence of gingivitis and afternoon dental plaque (per investigator’s discretion)
•7. Agree to maintain their same regular at-home oral hygiene routine and oral care products for this study duration
•8. Agree not to participate in any other oral care study for the duration of this study
•9. Agree to return for their scheduled visits and to follow all study procedures
•10. Refrain from eating, drinking* and chewing gum for at least 3 hours prior to this visit and agree to follow the same restriction prior to all visits *(Exception being allowed small sips of water up until 45 minutes prior to their appointment time)
•11. Refrain from performing any other oral hygiene after their regular morning oral hygiene prior to this visit (which had to be no later than 8 am) and agree to the same restriction prior to all visits

•1. Any disease or condition that could be expected to interfere with examination procedures or with the subject safely completing this study (including allergies to dyes or the need for pre-medication prior to dental procedures)
•2. Any condition requiring immediate dental treatment
•3. Fixed facial or lingual orthodontic appliances
•4. Use of antibiotics within 2 weeks prior to study initiation
•5. Receive dental prophylaxis within 1 month prior to study initiation

发起方

Procter & Gamble (United States)