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 teeth

Not Applicable

• Conditions: Oral Health; Evidence of dental plaque and gingivitis in an orthodontic population

• Registration Number: ISRCTN32122610
• Lead Sponsor: Procter & Gamble (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-15
• Last Update Posted: 4 April 2022
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Dental plaque (pre-brushing) measured by Turesky Modified Quigley Hein Plaque Index at<br> baseline, week 6 and week 12.<br> 2. Gingival inflammation measured by Modified Gingival Index at baseline, week 6 and week 12.<br>

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures.