A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.

NCT03416985 | Completed Results FDA Device

• 1 other identifier: 17-001622
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Although patients are typically informed about the risks of substandard oral hygiene and the contributing factors in oral/dental disease by dental professionals, research has shown that an undesirably high proportion of adults find thorough toothbrushing with a standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high worldwide levels of gingivitis and/or periodontitis.

Conditions

Dental Plaque Induced Gingivitis; Dental Plaque

Outcome Measures

Primary Outcomes (2)

• Plaque Index

  plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).

  Baseline, 1 month

• Gingival Index

  gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.

  Baseline, 1 month

Study Arms (3)

Manual Toothbrush

ACTIVE COMPARATOR

Patients will be asked to use a manual toothbrush for 30 days

Device: Oral B Healthy Clean Manual Toothbrush

Sonic Toothbrush

ACTIVE COMPARATOR

Patients will be asked to use a sonic toothbrush for 30 days

Device: BURST Sonic Oral Care

Pulsating Toothbrush

ACTIVE COMPARATOR

Patients will be asked to use a pulsating toothbrush for 30 days

Device: Philipps Sonicare DiamondClean 300 Series

Interventions

Oral B Healthy Clean Manual Toothbrush DEVICE

Manual Toothbrush

Manual Toothbrush

BURST Sonic Oral Care DEVICE

Electric sonic toothbrush

Sonic Toothbrush

Philipps Sonicare DiamondClean 300 Series DEVICE

Electric pulsating toothbrush

Pulsating Toothbrush

Eligibility Criteria

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

You may qualify if:

• Good overall health
• At least 20 teeth present, not including 3rd Molars
• Non-smoker

You may not qualify if:

• Poor manual dexterity or mentally handicap;
• Presence of removable intra-oral prosthesis
• Current orthodontic therapy
• Severe Periodontal condition or caries teeth in need of immediate attention
• Pregnant women
• Subjects that use medications that may effect oral health
• No Systemic diseases/conditions such as diabetes mellitus, heart disease.
• Use of plaque inhibiting toothpaste, mouthwash, interdental flossing in the period of the study

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA School of Dentistry

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Joan Pi Anfruns, DMD
• Organization: University of California Los Angeles

jpianfruns@dentistry.ucla.edu

310-825-0834

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: January 2, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 30, 2018
• Last Updated: December 24, 2019
• Results First Posted: December 24, 2019

Record last verified: 2019-12

Locations

US (1)