Clinical trial NCT04221334: Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush
Official title: Clinical Investigation Examining Plaque and Gingivitis Reductions of Connected Toothbrush Compared to Non-Connected Toothbrush: a Six-week Clinical Study in California
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Plaque, Dental
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
Collaborators: name: Loma Linda University
First posted: 2020-01-09
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: change in mean dental plaque
timeFrame: 3 and 6 weeks of product use
measure: change in mean gingivitis
timeFrame: 3 and 6 weeks of product use
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Yiming Yi, DDS/PhD
role: PRINCIPAL_INVESTIGATOR
References: