Gingivitis
Conditions
Keywords
power toothbrush, oscillating rotating
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
Interventions
DEVICEOscillating rotating power toothbrush
a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene
Sponsors
Sunstar, Inc.
Marquette University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
examiners will be unaware of which toothbrush has been assigned to each subject
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gingivitis | 12 weeks post-baseline | 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. |
Countries
United States
Participant flow
Recruitment details
Medically healthy subjects between 18 and 65 years of age were recruited by posting flyers around the Milwaukee area.
Participants by arm
| Arm | Count |
|---|---|
| Powered Toothbrush Intervention 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.
Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene | 23 |
| Powered Toothbrush Intervention 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.
Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene | 3,864 |
| Manual Toothbrush 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. | 24 |
| Manual Toothbrush 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. | 4,032 |
| Total | 7,943 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 4 | 3 |
Baseline characteristics
| Characteristic | Powered Toothbrush Intervention | Manual Toothbrush | Total |
|---|---|---|---|
| Age, Continuous | 27.13 Years STANDARD_DEVIATION 8.42 | 25.75 Years STANDARD_DEVIATION 10.16 | 26.43 Years STANDARD_DEVIATION 9.27 |
| Bleeding on probing | 0.23 Average Bleeding Score STANDARD_DEVIATION 0.08 | 0.27 Average Bleeding Score STANDARD_DEVIATION 0.08 | 0.25 Average Bleeding Score STANDARD_DEVIATION 0.09 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 0 / 23 | 0 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
Primary
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.
Time frame: 12 weeks post-baseline
Population: The analysis was on the number sites per patients. For BOP the score was for proportion of the bleeding sites. Similarly for MGI the score was full mouth average.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Powered Toothbrush Intervention | Change in Gingivitis | 0.14 score on a scale | Standard Deviation 0.07 |
| Manual Toothbrush | Change in Gingivitis | 0.19 score on a scale | Standard Deviation 0.1 |