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Powertoothbrushing for Treating Gingivitis

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oscillating rotating power toothbrush
Sponsored by
Marquette University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring power toothbrush, oscillating rotating

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A subject who meets all the following criteria will be eligible to enroll in this study.

    1. Age range 18 - 65 years
    2. Routine manual toothbrush user
    3. A Subject who agrees to use the assigned toothbrush as the only cleaning device for the study duration, refraining from daily interdental cleaning and/ or antiseptic mouthrinsing.
    4. Mild to moderate gingivitis as measured by A. Modified Gingival Index (MGI) average score of at least 1.2, and / or B. Bleeding on Probing (BOP) of at least 20% of all sites but not more than 50% of sites.
    5. Probing Pocket Depth (PPD) of 4 mm or lower
    6. At least 20 natural teeth - scoreable (crowns or bridgework are non-scoreable).

Exclusion Criteria:

  • Any subject meeting one of the following criteria will not be included in the study.

    1. Daily user of interdental cleaning devices, such as floss, floss picks, toothpicks, interdental brush, water flossing device
    2. Regular user of antimicrobial mouthrinses within one week of entry into study
    3. Professional prophylaxis within one month of entry into the study
    4. Use of antibiotics within one month prior to the baseline exam
    5. Signs of moderate to severe periodontitis or caries, categorized as PPD of 5 mm of higher and attachment loss of 3 mm or higher
    6. Subjects with orthodontic bands and/or dental appliances.
    7. Participated in an oral care related study in the last 90 days prior to this study
    8. Pregnant or lactating women
    9. Patients with a history of significant cardiovascular disease, diabetes, cancer, AIDS, or other organ impairment that would preclude their participation in the study
    10. Acute/concurrent illness such as hepatitis, herpes simplex infections, influenza, etc.
    11. History of rheumatic fever, cardiovascular valvular disease, artificial joint replacement or kidney or liver disorders
    12. Chronic use of steroids; limited use of NSAID's (≤ 325 mg/day)
    13. Current Smoker (within the last 3 months)
    14. Other medical or dental conditions that would affect the study
    15. Inability to commit to all necessary study visits from baseline to 12 weeks

Sites / Locations

  • Marquette University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Powered toothbrush intervention

Manual toothbrush

Arm Description

Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.

Subjects will be provided a manual toothbrush as the control group and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.

Outcomes

Primary Outcome Measures

Change in Gingivitis
Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2017
Last Updated
March 9, 2021
Sponsor
Marquette University
Collaborators
Sunstar, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03381339
Brief Title
Powertoothbrushing for Treating Gingivitis
Official Title
Powertoothbrushing for Treating Gingivitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marquette University
Collaborators
Sunstar, Inc.

4. Oversight

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

5. Study Description

Brief Summary
In this three-month interventional clinical trial for the treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene.
Detailed Description
In this single-masked, parallel-armed, interventional clinical trial for treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene. The primary outcome variable is the change from baseline in the Modified Gingival Index at 2, 4 and 12-weeks from Baseline. Secondary outcome variables include change from baseline in bleeding on probing as well as change from baseline in the Turesky Modification of the Quigley-Hein Plaque index measuring overnight plaque formation. There will also be an assessment of single use efficacy in reduction of overnight plaque levels at the baseline visit t

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
power toothbrush, oscillating rotating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 month home use parallel-arm design to assess the efficacy of powered toothbrush use in the treatment of gingivitis in a moderate sized population, n=70.
Masking
Investigator
Masking Description
examiners will be unaware of which toothbrush has been assigned to each subject
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Powered toothbrush intervention
Arm Type
Experimental
Arm Description
Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
Arm Title
Manual toothbrush
Arm Type
No Intervention
Arm Description
Subjects will be provided a manual toothbrush as the control group and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
Intervention Type
Device
Intervention Name(s)
Oscillating rotating power toothbrush
Other Intervention Name(s)
powertoothbrush
Intervention Description
a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene
Primary Outcome Measure Information:
Title
Change in Gingivitis
Description
Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe.
Time Frame
12 weeks post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A subject who meets all the following criteria will be eligible to enroll in this study. Age range 18 - 65 years Routine manual toothbrush user A Subject who agrees to use the assigned toothbrush as the only cleaning device for the study duration, refraining from daily interdental cleaning and/ or antiseptic mouthrinsing. Mild to moderate gingivitis as measured by A. Modified Gingival Index (MGI) average score of at least 1.2, and / or B. Bleeding on Probing (BOP) of at least 20% of all sites but not more than 50% of sites. Probing Pocket Depth (PPD) of 4 mm or lower At least 20 natural teeth - scoreable (crowns or bridgework are non-scoreable). Exclusion Criteria: Any subject meeting one of the following criteria will not be included in the study. Daily user of interdental cleaning devices, such as floss, floss picks, toothpicks, interdental brush, water flossing device Regular user of antimicrobial mouthrinses within one week of entry into study Professional prophylaxis within one month of entry into the study Use of antibiotics within one month prior to the baseline exam Signs of moderate to severe periodontitis or caries, categorized as PPD of 5 mm of higher and attachment loss of 3 mm or higher Subjects with orthodontic bands and/or dental appliances. Participated in an oral care related study in the last 90 days prior to this study Pregnant or lactating women Patients with a history of significant cardiovascular disease, diabetes, cancer, AIDS, or other organ impairment that would preclude their participation in the study Acute/concurrent illness such as hepatitis, herpes simplex infections, influenza, etc. History of rheumatic fever, cardiovascular valvular disease, artificial joint replacement or kidney or liver disorders Chronic use of steroids; limited use of NSAID's (≤ 325 mg/day) Current Smoker (within the last 3 months) Other medical or dental conditions that would affect the study Inability to commit to all necessary study visits from baseline to 12 weeks
Facility Information:
Facility Name
Marquette University School of Dentistry
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Powertoothbrushing for Treating Gingivitis

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