A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
|ClinicalTrials.gov Identifier: NCT03416985|
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : December 24, 2019
Last Update Posted : December 24, 2019
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Manual Toothbrush
Patients will be asked to use a manual toothbrush for 30 days
Device: Oral B Healthy Clean 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
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416985
|United States, California|
|UCLA School of Dentistry|
|Los Angeles, California, United States, 90095|