Powertoothbrushing for Treating Gingivitis

Gingivitis Clinical Trial

Official title:

Powertoothbrushing for Treating Gingivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381339
• Other study ID #: MarquetteU
• Status: Completed
• Phase: N/A
• Start date: December 5, 2017
• Est. completion date: June 25, 2019

Study information

• Verified date: March 2021
• Source: Marquette University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• Oscillating rotating power toothbrush
a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene

Locations

Country	Name	City	State
United States	Marquette University School of Dentistry	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Marquette University	Sunstar, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 weeks post-baseline