Powertoothbrushing for Treating Gingivitis

• Sponsor: Marquette University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03381339
• Collaborator: Sunstar, Inc. (Industry)
• Enrollment: 55
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.6
• Patients Per Site Per Month: 3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Device: Oscillating rotating power toothbrush	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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=70.3 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: Single (Investigator)
• Masking Description: examiners will be unaware of which toothbrush has been assigned to each subject
• Primary Purpose: Treatment
• Official Title: Powertoothbrushing for Treating Gingivitis
• Actual Study Start Date: Dec 5, 2017
• Actual Primary Completion Date: Jun 25, 2019
• Actual Study Completion Date: Jun 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Oscillating rotating power toothbrush; a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene; Other Names: powertoothbrush
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marquette University School of Dentistry	Milwaukee	Wisconsin	United States	53233

Sponsors and Collaborators

• Marquette University
• Sunstar, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Aug 14, 2018

More Information

Publications

None provided.

• Responsible Party: Marquette University
• ClinicalTrials.gov Identifier: NCT03381339
• Other Study ID Numbers: MarquetteU
• First Posted: Dec 22, 2017
• Last Update Posted: Apr 5, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Marquette University: power toothbrush, oscillating rotating
• Additional relevant MeSH terms: Gingivitis

Study Results

Participant Flow

Recruitment Details	Medically healthy subjects between 18 and 65 years of age were recruited by posting flyers around the Milwaukee area.

Arm/Group Title	Powered Toothbrush Intervention	Manual Toothbrush
Arm/Group Description	Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written and professional oral instructions on its proper use at baseline 2 and 4 weeks. 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	Subjects will be provided a manual toothbrush as the control group and given written and professional oral instructions on its proper use at baseline, 2 and 4 weeks. 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.
Period Title: Overall Study
STARTED	27	28
COMPLETED	23	24
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Powered Toothbrush Intervention	Manual Toothbrush	Total
Arm/Group 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. Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene	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.	Total of all reporting groups
Overall Participants	23	24	47
Overall Bleeding Sites	3864	4032	7896
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	27.13 (8.42)	25.75 (10.16)	26.43 (9.27)
Sex: Female, Male (Count of Participants)
Female	16 69.6%	14 58.3%	30 63.8%
Male	7 30.4%	10 41.7%	17 36.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	23 100%	24 100%	47 100%
Bleeding on probing (Average Bleeding Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Average Bleeding Score]	0.23 (0.08)	0.27 (0.08)	0.25 (0.09)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Powered Toothbrush Intervention	Manual Toothbrush
Arm/Group Description	Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written and professional oral instructions on its proper use at baseline 2 and 4 weeks. 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	Subjects will be provided a manual toothbrush as the control group and given written and professional oral instructions on its proper use at baseline, 2 and 4 weeks. 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.
Measure Participants	23	24
Mean (Standard Deviation) [score on a scale]	0.14 (0.07)	0.19 (0.10)

Adverse Events

Time Frame	12 Weeks
Adverse Event Reporting Description	Pain
Arm/Group Title	Powered Toothbrush Intervention		Manual Toothbrush
Arm/Group Description	The patients were given power toothbrush with instructions to use		The patients were given power manual toothbrush with instructions to use
All Cause Mortality
	Powered Toothbrush Intervention		Manual Toothbrush
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)
Serious Adverse Events
	Powered Toothbrush Intervention		Manual Toothbrush
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Powered Toothbrush Intervention		Manual Toothbrush
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.