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Evaluation of 3 Oral Self-care Regimens on Clinical Signs of Inflammation and Plaque

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Waterpik Water Flosser
Oral-B Water Flosser
Waxed Dental Floss
Sponsored by
Water Pik, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Have provided written informed consent prior to being entered into the study. Be between 18 and 75 years of age, male or female. Have at least twenty (20) natural teeth (5 evaluable in each quadrant) with scorable facial and lingual surfaces as determined by the clinical examiner. Nonsmoking (assessed as < 1 cigarette every day for at least a year). Have a mean baseline plaque index score of ≥0.60 as determined by the Rustogi Modification of the Navy Plaque Index (RMNPI). Have a mean baseline gingival index score of ≥1.75 as determined by the Modified Gingival Index (MGI). Have a mean bleeding on probing score of 50%. Have probe readings ≤4 mm. Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures any time during the study. Agree to abstain from the use of chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at home use) and all other oral hygiene other than the study procedures for the duration of the study. Agree to refrain from all oral hygiene on the morning of each evaluation visit and to refrain from eating, drinking or chewing gum for 4 hours prior to each evaluation visit. Agree to comply with the conditions and schedule of the study. Exclusion Criteria: Physical limitations or restrictions that might preclude normal use of devices. Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity. Supra- or subgingival calculus that might interfere with evaluations as determined by the clinical examiner. Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the clinical examiner. Conditions requiring antibiotic treatment prior to dental procedures. History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable disease, (e.g. COVID-19, AIDS). Subjects with grossly carious, fully crowned, or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures. Treatment with antibiotics within the 1-month period before the baseline examination, or a condition that is likely to require antibiotic treatment over the course of the trial. Chronic treatment (2-weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, Coumadin, nonsteroidal anti-inflammatory drugs, and aspirin (325 mg)) within 1- month of the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment. Have moderate to severe periodontal disease or being actively treated for periodontal disease. Concomitant periodontal therapy other than prophylaxis in the last 6 months. Professional prophylaxis within 1 month prior to the baseline clinical evaluation. Subjects who participate in a gingivitis study in the past month. History of significant adverse event following use of oral hygiene products such as toothpastes and mouth rinses. Subjects who are allergic to any ingredients in Crest® Cavity Protection or Colgate® Cavity Protection toothpaste. Self-reported pregnancy or lactating women since hormonal changes can exaggerate gingival response to dental plaque.

Sites / Locations

  • All Sum Research Center Ltd.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Manual toothbrush and water flosser with standard jet tip

Manual toothbrush and water flosser with targeted jet tip

Manual toothbrush and dental floss

Arm Description

Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening

Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening

Brush with a standard ADA manual toothbrush twice daily followed by dental flossing once in the evening

Outcomes

Primary Outcome Measures

Bleeding on probing
Bleeding recorded on 6 sites per tooth within 30 seconds of instrumentation. 0 = no bleeding, 1= bleeding. Bleeding determined by number of sites bleeding divided by total number of sites = percent bleeding

Secondary Outcome Measures

Modified gingival index
Visual assessment of the gingival tissue. 0 = absence of inflammation, 1 = mild inflammation (slight change in color, little change in texture of any porting of but not the entire marginal or papillary gingival area), 3 = moderate inflammation (glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival area), 4 = severe inflammation (marked redness, edema and/or hypertrophy of the marginal or papillary gingival area, spontaneous bleeding, congestion, or ulceration.
Rustogi Modification of Navy Plaque Index
Plaque is assessed for each tooth area (divided into 9 sections labeled A through I) and scored using the following scale: 0 = absent, and 1 = present. Facial and lingual surfaces of all gradable teeth are scored and a mean plaque index is calculated for each subject at each examination. Subjects' scores were calculated for whole mouth (A through I), along the gingival margin (A through C), and at the proximal (approximal) areas (D and F).

Full Information

First Posted
January 9, 2023
Last Updated
March 15, 2023
Sponsor
Water Pik, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05766995
Brief Title
Evaluation of 3 Oral Self-care Regimens on Clinical Signs of Inflammation and Plaque
Official Title
Efficacy of Three Oral Self-care Regimens on Clinical Parameters of Inflammation and Plaque: Part 1 - a Four Week Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
September 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Water Pik, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
To compare three different oral hygiene regimens on changes in gum tissue appearance, gum bleeding, and plaque scores.
Detailed Description
The goal of this clinical trial was to compare the effect of different battery powered water in and adult population with mild to moderate gingivitis. The main questions it aims to answer are: Is there a difference between the two water flosser devices on gum bleeding scores? Is there a difference between the two water flosser devices on plaque accumulation and removal? Is there a difference between the two water flosser devices on signs of gingivitis? Researchers will compare the two groups using a water flosser (experimental) to see how it compares to traditional brushing and flossing (control).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual toothbrush and water flosser with standard jet tip
Arm Type
Experimental
Arm Description
Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening
Arm Title
Manual toothbrush and water flosser with targeted jet tip
Arm Type
Experimental
Arm Description
Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening
Arm Title
Manual toothbrush and dental floss
Arm Type
Active Comparator
Arm Description
Brush with a standard ADA manual toothbrush twice daily followed by dental flossing once in the evening
Intervention Type
Device
Intervention Name(s)
Waterpik Water Flosser
Other Intervention Name(s)
dental water jet, oral irrigator
Intervention Description
A pulsating water flosser and jet tip designed to clean between the teeth and below the gingival margin.
Intervention Type
Device
Intervention Name(s)
Oral-B Water Flosser
Other Intervention Name(s)
dental water jet, oral irrigator
Intervention Description
A water flosser and specialized tip that delivers water with microbubbles of air
Intervention Type
Device
Intervention Name(s)
Waxed Dental Floss
Intervention Description
Nylon string used to clean between the teeth manually
Primary Outcome Measure Information:
Title
Bleeding on probing
Description
Bleeding recorded on 6 sites per tooth within 30 seconds of instrumentation. 0 = no bleeding, 1= bleeding. Bleeding determined by number of sites bleeding divided by total number of sites = percent bleeding
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Modified gingival index
Description
Visual assessment of the gingival tissue. 0 = absence of inflammation, 1 = mild inflammation (slight change in color, little change in texture of any porting of but not the entire marginal or papillary gingival area), 3 = moderate inflammation (glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival area), 4 = severe inflammation (marked redness, edema and/or hypertrophy of the marginal or papillary gingival area, spontaneous bleeding, congestion, or ulceration.
Time Frame
4 weeks
Title
Rustogi Modification of Navy Plaque Index
Description
Plaque is assessed for each tooth area (divided into 9 sections labeled A through I) and scored using the following scale: 0 = absent, and 1 = present. Facial and lingual surfaces of all gradable teeth are scored and a mean plaque index is calculated for each subject at each examination. Subjects' scores were calculated for whole mouth (A through I), along the gingival margin (A through C), and at the proximal (approximal) areas (D and F).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have provided written informed consent prior to being entered into the study. Be between 18 and 75 years of age, male or female. Have at least twenty (20) natural teeth (5 evaluable in each quadrant) with scorable facial and lingual surfaces as determined by the clinical examiner. Nonsmoking (assessed as < 1 cigarette every day for at least a year). Have a mean baseline plaque index score of ≥0.60 as determined by the Rustogi Modification of the Navy Plaque Index (RMNPI). Have a mean baseline gingival index score of ≥1.75 as determined by the Modified Gingival Index (MGI). Have a mean bleeding on probing score of 50%. Have probe readings ≤4 mm. Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures any time during the study. Agree to abstain from the use of chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at home use) and all other oral hygiene other than the study procedures for the duration of the study. Agree to refrain from all oral hygiene on the morning of each evaluation visit and to refrain from eating, drinking or chewing gum for 4 hours prior to each evaluation visit. Agree to comply with the conditions and schedule of the study. Exclusion Criteria: Physical limitations or restrictions that might preclude normal use of devices. Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity. Supra- or subgingival calculus that might interfere with evaluations as determined by the clinical examiner. Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the clinical examiner. Conditions requiring antibiotic treatment prior to dental procedures. History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable disease, (e.g. COVID-19, AIDS). Subjects with grossly carious, fully crowned, or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures. Treatment with antibiotics within the 1-month period before the baseline examination, or a condition that is likely to require antibiotic treatment over the course of the trial. Chronic treatment (2-weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, Coumadin, nonsteroidal anti-inflammatory drugs, and aspirin (325 mg)) within 1- month of the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment. Have moderate to severe periodontal disease or being actively treated for periodontal disease. Concomitant periodontal therapy other than prophylaxis in the last 6 months. Professional prophylaxis within 1 month prior to the baseline clinical evaluation. Subjects who participate in a gingivitis study in the past month. History of significant adverse event following use of oral hygiene products such as toothpastes and mouth rinses. Subjects who are allergic to any ingredients in Crest® Cavity Protection or Colgate® Cavity Protection toothpaste. Self-reported pregnancy or lactating women since hormonal changes can exaggerate gingival response to dental plaque.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Mancinelli Lyle
Organizational Affiliation
Water Pik, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
All Sum Research Center Ltd.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5N 6J2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of 3 Oral Self-care Regimens on Clinical Signs of Inflammation and Plaque

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