Clinical trial NCT04899440: Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use
Official title: An Experimental Clinical Study to Assess the Gingivitis and Plaque Reduction Efficacy of an Oral-Irrigator After Three Weeks of Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Gingivitis
Plaque
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 enrolled in this study. Subjects will be evaluated for gingivitis using the Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI) and evaluated for plaque using the Turesky Modified Quigley-Hein Plaque Index (TQHPI) at two (2) time points: Baseline and after three (3) weeks of product use. Qualified subjects will be stratified and randomly assigned to one of the two treatment groups, toothbrushing on conjunction with an Oral Irrigator or toothbrushing without an Oral Irrigator (N=15/treatment). Subjects will be instructed to brush twice a day for approximately three (3) weeks with their assigned products and return for plaque and gingivitis measures at approximately three (3) weeks after the Baseline visit.

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.

Primary outcomes:
measure: MGI-Modified Gingival Index
timeFrame: MGI Score after 3 weeks of product use.
measure: GBI-Gingival Bleeding Index
timeFrame: GBI score after 3 weeks of product use.
Secondary outcomes:
measure: Plaque- TMQHP
timeFrame: TMQHP score after 3 weeks of product use.
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
References: