Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush

Gingivitis Clinical Trial

— Connected  

Official title:

Clinical Investigation Examining Plaque and Gingivitis Reductions of Connected Toothbrush Compared to Non-Connected Toothbrush: a Six-week Clinical Study in California

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04221334
• Other study ID #: CRO-2018-12-CTB-PLA-LLU-YPZ
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: July 27, 2019

Study information

• Verified date: January 2020
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical research study is to assess plaque and gingivitis reductions of Connected Toothbrush compared to Non-Connected Toothbrush over a six-week clinical study.

Description:

A phase II randomized, single-center, two-cell, examiner-blind and parallel-group clinical study conducted in the Loma Linda, California area, to investigate the clinical efficacy of a connected power toothbrush as compared to a non-connected power toothbrush in reducing dental plaque and gingivitis as measured by the Rustogi Modification of the Navy Plaque Index and Löe and Silness Gingival Index over a 6-week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 27, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. • Male and female subjects had to be between the ages of 18 and 70 (inclusive),

2. • Subjects needed to be available for the duration (6 weeks) of the study,

3. • Subjects had to possess minimum of 20 uncrowned permanent natural teeth (excluding third molars),

4. • Subjects were required to present and an initial mean gingivitis score of at least 1.0 as determined by the use of the Löe-Silness Gingival Index,

5. • Subjects were required to present an initial mean plaque index of at least 0.6 as determined by the use of the Rustogi Modification of the Navy Plaque Index,

6. • Subjects had to sign an Informed Consent form,

7. • Subjects had to be in general good health and

8. • Subjects with no known history of allergies to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring of the study.

Exclusion:

1. • Medical condition which require pre-medication prior to dental visits/procedures,

2. • The presence of partial removable dentures,

3. • Subjects who had advanced periodontal disease (gum disease),

4. • Five (5) or more decayed or untreated dental sites at screening (cavities),

5. • Subjects with diseases of the soft or hard oral tissues,

6. • Subjects with orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring),

7. • Dry mouth as a result of a medication or medical condition,

8. • Use of drugs that can currently affect salivary flow,

9. • Use of antibiotics one (1) month prior to or during this study,

10. • Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion,

11. • Chronic (>3 3 times/week) use of medications that are known to affect gingival tissues including steroids or non-steroidal anti-inflammatory medications or the listed medications (phenytoin, calcium antagonists, Coumadin, cyclosporine),

12. • Any diseases that might affect the assessment of the study treatment or gingival tissues (rheumatoid arthritis, Crohn's disease, diabetes), ongoing chemotherapy for cancer, radiation therapy for head and neck cancer,

13. • Pregnant or breast-feeding women were excluded from the study,

14. • Subjects who participated in any other clinical study in the month preceding this study,

15. • Allergic to common dentifrice ingredients,

16. • Medical condition which prohibits not eating/drinking or chewing gum for 4 hours prior to their scheduled visit,

17. • Immune compromised individuals (AIDS, immune suppressive drug therapy) and

18. • History of infectious disease or other blood borne diseases (Hepatitis series, HIV).

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis
• Plaque, Dental

Intervention

Device:
• Electric Toothbrush
Electric Toothbrush used to remove dental plaque and resolve gingivitis

Other:
• oral health care application
phone application that shows the user brushing efficiency real time

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Colgate Palmolive	Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in mean dental plaque	Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject.	3 and 6 weeks of product use
Primary	change in mean gingivitis	gingivitis measurement is served as secondary efficacy variable	3 and 6 weeks of product use