Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use

NCT04899440 | Completed Results

• 1 other identifier: 2021043
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Plaque

Outcome Measures

Primary Outcomes (2)

• MGI-Modified Gingival Index

  Modified Gingival Index score after 3 weeks of product use. Gingivitis will be scored on the buccal and lingual marginal gingival and interdental papilla of all scorable teeth (six scores per tooth):0 = normal (absence of inflammation); 1 = mild inflammation (slight change of color, little change in texture) of any portion of the gingival unit; 2 = mild inflammation of the entire gingival unit; 3 = moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the gingival unit; 4 = severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding or ulceration) of the gingival unit. MGI whole mouth score is computed by summing the scores and dividing by the number of scorable sites examined.

  MGI Score after 3 weeks of product use.

• GBI-Gingival Bleeding Index

  Gingival Bleeding Index score after 3 weeks of product use. Each of the 3 gingival areas, i.e., buccal, mesial/dystal and lingual, of the teeth will be probed in this manner waiting approximately 30 seconds before recording the number of gingival units which bleed, according to the following scale: 0 = absence of bleeding after 30 seconds; 1 = bleeding observed after 30 seconds; 2 = immediate bleeding observed. GBI whole mouth score is computed by summing the scores and dividing by the number of scorable sites examined.

  GBI score after 3 weeks of product use.

Secondary Outcomes (1)

• Plaque- TMQHP

  TMQHP score after 3 weeks of product use.

Study Arms (2)

Test Regimen

EXPERIMENTAL

Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily

Device: Water Flosser

Control Regimen

SHAM COMPARATOR

Manual toothbrush + toothpaste Subjects will brush their teeth twice daily

Other: Control

Interventions

Water Flosser DEVICE

A pressurized stream of water to reduce gingivitis and remove adherent plaque

Test Regimen

Control OTHER

No Oral Irrigator Control

Control Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Salus Research

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Procter & Gamble

combs.cs@pg.com

5136225362

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Subjects will proceed to an area separated from the examiner/examination area to receive supervised oral hygiene instructions and product usage instructions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: June 3, 2021
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: August 1, 2022
• Results First Posted: August 1, 2022

Record last verified: 2022-07

Locations

US (1)