N/A
N=30
Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use
Gingivitis · Plaque
Bottom Line
View on ClinicalTrials.gov: NCT04899440 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: MGI-Modified Gingival Index — 0.30; -0.13 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Water Flosser (Device); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MGI-Modified Gingival Index |
0.30; -0.13 | — |
| PRIMARY GBI-Gingival Bleeding Index |
0.16; -0.06 | — |
| SECONDARY Plaque- TMQHP |
0.28; 0.10 | — |
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 Modified Gingival Index and the Gingival Bleeding Index. The secondary objective is to evaluate the efficacy of an Oral Irrigator in the reduction of plaque compared to a negative control using the extended Turesky Modified Quigley-Hein Index (TQHPI) after 3 weeks of use.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04899440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.