Status:
COMPLETED
Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use
Lead Sponsor:
Procter and Gamble
Conditions:
Gingivitis
Plaque
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this exploratory study is to evaluate the efficacy of an Oral Irrigator in the reduction of gingivitis compared to a negative control over a 3 week period by using the Modifie...
Detailed Description
This is a single-center, examiner-blind, three (3) week, two (2) treatment, parallel group, randomized study design. Thirty (30) subjects who have shown evidence of gingivitis and plaque will be enrol...
Eligibility Criteria
Inclusion
- Give written informed consent and receive a copy of the signed Informed Consent form;
- Be at least 18 years of age;
- Typically use a manual toothbrush;
- Be in good general health as determined by the investigator/designee based on a review/update of their medical history;
- Possess a minimum of 16 scorable teeth (excluding third molars) with facial and lingual scorable surfaces;
- Have a Baseline MGI score between 1.75 and 2.5;
- Have a Baseline TQHPI score of at least 2.00;
- Have a Baseline between 20 and 80 Bleeding sites;
- Abstained from all oral hygiene procedures for approximately 12 hours prior to this visit and agree to do the same prior to the subsequent visit;
- Abstained from eating, drinking\*, chewing gum and using tobacco for at least 4 hours prior to this visit and agree to do the same prior to the subsequent visit. \*(Exception: Allowed small sips of water up until 45 minutes prior to their appointment time.)
- Agree not to participate in any other oral care study for the duration of this study;
- Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study;
- Agree to refrain from using any non-study toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration; and
- Agree to return for their scheduled visits and to follow all study procedures.
Exclusion
- Hypersensitivity to dyes;
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- Any carious lesions requiring restorative treatment;
- Active treatment for periodontitis;
- Any fixed facial orthodontic appliances or retainers;
- Use of any antibiotic medication or a prescription mouth rinse any time within the 2 weeks prior to study initiation; or
- Any disease or conditions that could be expected to interfere with examination; procedures or the subject safely completing the study.
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04899440
Start Date
June 3 2021
End Date
June 24 2021
Last Update
August 1 2022
Active Locations (1)
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1
Salus Research
Fort Wayne, Indiana, United States, 46825