A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
Primary Purpose
Dental Plaque Induced Gingivitis, Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral B Healthy Clean Manual Toothbrush
BURST Sonic Oral Care
Philipps Sonicare DiamondClean 300 Series
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque Induced Gingivitis
Eligibility Criteria
Inclusion Criteria:
- Good overall health
- At least 20 teeth present, not including 3rd Molars
- Non-smoker
Exclusion Criteria:
- 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
Sites / Locations
- UCLA School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Manual Toothbrush
Sonic Toothbrush
Pulsating Toothbrush
Arm Description
Patients will be asked to use a manual toothbrush for 30 days
Patients will be asked to use a sonic toothbrush for 30 days
Patients will be asked to use a pulsating toothbrush for 30 days
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03416985
First Posted
January 24, 2018
Last Updated
December 6, 2019
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03416985
Brief Title
A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
Official Title
A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque Induced Gingivitis, Dental Plaque
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Toothbrush
Arm Type
Active Comparator
Arm Description
Patients will be asked to use a manual toothbrush for 30 days
Arm Title
Sonic Toothbrush
Arm Type
Active Comparator
Arm Description
Patients will be asked to use a sonic toothbrush for 30 days
Arm Title
Pulsating Toothbrush
Arm Type
Active Comparator
Arm Description
Patients will be asked to use a pulsating toothbrush for 30 days
Intervention Type
Device
Intervention Name(s)
Oral B Healthy Clean Manual Toothbrush
Intervention Description
Manual Toothbrush
Intervention Type
Device
Intervention Name(s)
BURST Sonic Oral Care
Intervention Description
Electric sonic toothbrush
Intervention Type
Device
Intervention Name(s)
Philipps Sonicare DiamondClean 300 Series
Intervention Description
Electric pulsating toothbrush
Primary Outcome Measure Information:
Title
Plaque Index
Description
plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Time Frame
Baseline, 1 month
Title
Gingival Index
Description
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.
Time Frame
Baseline, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Good overall health
At least 20 teeth present, not including 3rd Molars
Non-smoker
Exclusion Criteria:
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
Facility Information:
Facility Name
UCLA School of Dentistry
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
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