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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416985
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Joan PiAnfruns, DMD, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Dental Plaque Induced Gingivitis Dental Plaque Device: Oral B Healthy Clean Manual Toothbrush Device: BURST Sonic Oral Care Device: Philipps Sonicare DiamondClean 300 Series Not Applicable

Detailed Description:

The purpose of this study is to clinically evaluate the plaque removal efficacy of two electric powered toothbrushes after a single use, as well as the effect on plaque accumulation and gingivitis after 14 days and 30 days period. Simultaneously, a comparison against a manual toothbrush will be made.

Study design: randomised, single blinded, parallel.

After the screening procedure and based on inclusion requirements, all subjects will receive oral prophylaxis (T0) to ensure a baseline of 0 Plaque Index (PI) prior to the first appointment (T1). The subjects will be instructed not to use a tooth brush or any mechanical cleaning device until the initial PI and Gingival Indexes (GI) are taken at 24 hours after T0.

The subjects will be randomized into 3 groups, and the will be provided one of the three evaluated toothbrushes, as well as toothpaste. All subjects will be using identical toothpaste and will receive oral hygiene instructions based on the manufacturer's recommendations.

At T1 initial GI and PI will be taken prior to brushing followed by a second PI reading immediately after the first use of the power driven toothbrush.

The subjects will be instructed to brush twice a day for a period of 2 minutes (following the programmed toothbrush timer) and refrain from using dental floss, tooth pick or any mechanical oral hygiene aid for the period of the study.

On the second visit at 14 days (T2) and third visit at 30 days (T3), additional GI and PI readings will be taken and data will be recorded. All measurements and clinical examinations will be performed by a single blinded examiner. Evaluation on teeth will be made on six teeth #3,7,12,19,23 and 28 (mesio-buccal, buccal, disto-buccal and mesio-lingual, lingual, disto-lingual) following the Silness-Loe Index.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : December 30, 2018

Arm Intervention/treatment
Active Comparator: Manual Toothbrush
Patients will be asked to use a manual toothbrush for 30 days
Device: Oral B Healthy Clean Manual Toothbrush
Manual Toothbrush

Active Comparator: Sonic Toothbrush
Patients will be asked to use a sonic toothbrush for 30 days
Device: BURST Sonic Oral Care
Electric sonic toothbrush

Active Comparator: Pulsating Toothbrush
Patients will be asked to use a pulsating toothbrush for 30 days
Device: Philipps Sonicare DiamondClean 300 Series
Electric pulsating toothbrush




Primary Outcome Measures :
  1. Plaque Index [ Time Frame: Baseline, 1 month ]
    plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).

  2. Gingival Index [ Time Frame: Baseline, 1 month ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416985


Locations
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United States, California
UCLA School of Dentistry
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Joan PiAnfruns, DMD, University of California, Los Angeles:
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Responsible Party: Joan PiAnfruns, DMD, Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03416985    
Other Study ID Numbers: 17-001622
First Posted: January 31, 2018    Key Record Dates
Results First Posted: December 24, 2019
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases