A study to assess the effect of a new toothpaste at reducing gum disease

Not Applicable

Completed

• Conditions: Mild to moderate gingivitis (gum disease); Oral Health

• Registration Number: ISRCTN60282575
• Lead Sponsor: Procter & Gamble (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-08
• Study Completion: 2021-09-30
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Give written informed consent prior to study participation and be given a signed copy of their informed consent form;
2. Be at least 18 years of age and typically use a manual toothbrush
3. Be in good general health as determined by the investigator/designee based on a review/update of their medical history
4. Possess a minimum of 20 natural teeth with facial and lingual scorable surfaces
5. Have a Baseline whole mouth mean MGI score of at least 1.5 but not more than 2.5
6. Have established gingivitis with 10 - 70 % bleeding sites (sites with a GBI score of 1 or 2) for baseline whole mouth mean
7. Agree not to participate in any other oral care study for the duration of this study
8. Agree not to have any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received at any time during the course of this study
9. Agree to refrain from using any non-study oral hygiene products for the study duration
10. Agree to return for all their scheduled visits and to follow all study procedures

Exclusion Criteria

1. Any 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, anti-inflammatory, anti-coagulant medications, chlorhexidine mouth rinse or a dental prophylaxis any time within the previous 2 weeks
7. Have any of the following: orthodontic appliances, removable partial dentures, or peri/oral piercings
8. Oral/gum surgery within the previous two months
9. Excessive calculus presence that interferes with the probing examination for Gingival Bleeding Index
10. Performing any oral hygiene the morning of their Baseline study visit
11. Use of medicated lozenges, breath mints, eating, drinking, smoking or chewing gum for at least 4 hours prior to their Baseline visit (Small sips of water will be allowed up to 45 minutes prior to the visit)
12. 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