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

NCT04221334 | Completed FDA Device

• 1 other identifier: CRO-2018-12-CTB-PLA-LLU-YPZ
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Plaque, Dental

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental Toothbrush 1

ACTIVE COMPARATOR

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

Device: Electric Toothbrush; Other: oral health care application

Experimental Toothbrush 2

ACTIVE COMPARATOR

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

Interventions

Electric Toothbrush DEVICE

Electric Toothbrush used to remove dental plaque and resolve gingivitis

Experimental Toothbrush 1; Experimental Toothbrush 2

oral health care application OTHER

phone application that shows the user brushing efficiency real time

Experimental Toothbrush 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects had to be between the ages of 18 and 70 (inclusive),
• Subjects needed to be available for the duration (6 weeks) of the study,
• Subjects had to possess minimum of 20 uncrowned permanent natural teeth (excluding third molars),
• 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,
• 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,
• Subjects had to sign an Informed Consent form,
• Subjects had to be in general good health and
• 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.

You may not qualify if:

• Medical condition which require pre-medication prior to dental visits/procedures,
• The presence of partial removable dentures,
• Subjects who had advanced periodontal disease (gum disease),
• Five (5) or more decayed or untreated dental sites at screening (cavities),
• Subjects with diseases of the soft or hard oral tissues,
• Subjects with orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring),
• Dry mouth as a result of a medication or medical condition,
• Use of drugs that can currently affect salivary flow,
• Use of antibiotics one (1) month prior to or during this study,
• Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion,
• 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),
• 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,
• Pregnant or breast-feeding women were excluded from the study,
• Subjects who participated in any other clinical study in the month preceding this study,
• Allergic to common dentifrice ingredients,

Sponsors & Collaborators

• Colgate Palmolive: lead
• Loma Linda University: collaborator

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Yiming Yi, DDS/PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Product Code: XX Brush twice daily (morning and evening) for at least 2 minutes each time Cover the entire length of bristles with toothpaste
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: January 9, 2020
• Study Start: April 30, 2019
• Primary Completion: July 3, 2019
• Study Completion: July 27, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)