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

NCT ID: NCT04221334

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2019-07-27

Brief 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.

Detailed 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.

Conditions

Gingivitis; Plaque, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Experimental Toothbrush 1

1\. A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.

Group Type: ACTIVE_COMPARATOR

Electric Toothbrush

Intervention Type: DEVICE

Electric Toothbrush used to remove dental plaque and resolve gingivitis

oral health care application

Intervention Type: OTHER

phone application that shows the user brushing efficiency real time

Experimental Toothbrush 2

2\. A non-connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.

Group Type: ACTIVE_COMPARATOR

Electric Toothbrush

Intervention Type: DEVICE

Electric Toothbrush used to remove dental plaque and resolve gingivitis

Interventions

Electric Toothbrush

Electric Toothbrush used to remove dental plaque and resolve gingivitis

Intervention Type: DEVICE

oral health care application

phone application that shows the user brushing efficiency real time

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: collaborator

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yiming Yi, DDS/PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

Other Identifiers

CRO-2018-12-CTB-PLA-LLU-YPZ

Identifier Type: -

Identifier Source: org_study_id