Efficacy of Electric 3D Versus Manual Toothbrushes in Patients With Fixed Orthodontic Appliances
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|ClinicalTrials.gov Identifier: NCT02699931|
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : June 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis Dental Plaque||Device: Electric3D Device: Manual||Not Applicable|
This trial is designed as a randomized, controlled, investigator blinded superiority trial, with two parallel groups and a 1:1 allocation ratio. Equal number of males and females will be allocated to each group.
One group of orthodontic patients will receive an electric toothbrush with orthodontic head and the other group will receive a manual orthodontic brush. Tooth brushing instructions will be provided. Measurements of two plaque indices and two gingival indices will be taken at baseline and at 3 monthly intervals.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized, Investigator-blinded, 3-month, Parallel Group Clinical Study to Compare the Efficacy of Electric 3D Toothbrushes Versus Manual Toothbrushes in Patients With Fixed Orthodontic Appliances|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||April 2019|
3D electric toothbrush (Oral-B) with orthodontic head.
Oral-B 3D with orthodontic head
Active Comparator: Manual
Manual orthodontic toothbrush (Oral-B).
- Modified Silness and Löe plaque index [ Time Frame: Baseline and monthly for 3 months ]
- Modified Full mouth plaque score [ Time Frame: Baseline and monthly for 3 months ]
- Modified Gingival index [ Time Frame: Baseline and monthly for 3 months ]
- Modified Simplified Gingival index [ Time Frame: Baseline and monthly for 3 months ]
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): NCT02699931
|Department of Orthodontics, School of Dentistry|
|Athens, Greece, 11527|
|Principal Investigator:||Demetrios J Halazonetis||National and Kapodistrian University of Athens|