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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Plaque, Dental
• Intervention / Treatment: Device: Electric Toothbrush; Other: oral health care application

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Experimental Toothbrush 1; 1. A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.	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
ACTIVE_COMPARATOR: 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.	Device: Electric Toothbrush; Electric Toothbrush used to remove dental plaque and resolve gingivitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change in mean gingivitis	gingivitis measurement is served as secondary efficacy variable	3 and 6 weeks of product use

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Collaborators: Loma Linda University
• Investigators: Principal Investigator: Yiming Yi, DDS/PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2019
• Primary Completion (ACTUAL): July 3, 2019
• Study Completion (ACTUAL): July 27, 2019

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (ACTUAL): January 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Gingivitis; Dental Plaque
• Other Study ID Numbers: CRO-2018-12-CTB-PLA-LLU-YPZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes