General healthy children between 3-10 years old with evidence of dental plaque and gingivitis Oral Health Gingivitis and periodontal diseases
Conditions
Interventions
Participants are stratified at baseline on mean gingivitis score, mean plaque index and gender within the two age groups (3-6 years and 7-10 years). Within these strata, participants are randomly assi
Sponsors
Procter & Gamble (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gingival inflammation measured by Modified Gingival Index at baseline and week 4 2. Dental plaque (pre-brushing) measured by Turesky Modified Quigley Hein Plaque Index at baseline and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Israel
Outcome results
None listed