Powertoothbrushing for Treating Gingivitis

NCT03381339 | Completed Results FDA Device

• 1 other identifier: MarquetteU
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

power toothbrush, oscillating rotating

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks post-baseline

Study Arms (2)

Powered toothbrush intervention

EXPERIMENTAL

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

Manual toothbrush

NO INTERVENTION

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.

Interventions

Oscillating rotating power toothbrush DEVICE

a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene

Also known as: powertoothbrush

Powered toothbrush intervention

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Marquette University: lead
• Sunstar, Inc.: collaborator

Study Sites (1)

Marquette University School of Dentistry

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Associate Dean
• Organization: Marquette Univeristy

andrew.dentino@marquette.edu

4142885944

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: examiners will be unaware of which toothbrush has been assigned to each subject
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 22, 2017
• Study Start: December 5, 2017
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: April 5, 2021
• Results First Posted: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)