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Efficacy of Electric 3D Versus Manual Toothbrushes in Patients With Fixed Orthodontic Appliances

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: NCT02699931
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Demetrios Halazonetis, National and Kapodistrian University of Athens

Tracking Information
First Submitted Date  ICMJE March 1, 2016
First Posted Date  ICMJE March 7, 2016
Last Update Posted Date June 6, 2019
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Electric 3D Versus Manual Toothbrushes in Patients With Fixed Orthodontic Appliances
Official Title  ICMJE 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
Brief Summary This study evaluates if electric toothbrushes with a 3D action (rotation / oscillation and pulsation) are more effective than manual toothbrushes in removing plaque and reducing gingival inflammation in patients under orthodontic treatment with fixed appliances.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Gingivitis
  • Dental Plaque
Intervention  ICMJE
  • Device: Electric3D
    Oral-B 3D with orthodontic head
  • Device: Manual
    Oral-B orthodontic
Study Arms  ICMJE
  • Experimental: Electric3D
    3D electric toothbrush (Oral-B) with orthodontic head.
    Intervention: Device: Electric3D
  • Active Comparator: Manual
    Manual orthodontic toothbrush (Oral-B).
    Intervention: Device: Manual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Age between 12 and 16 years. Good general health according to a recent full medical history. Fixed labial orthodontic appliances on all teeth from central incisor to first molar (bands on first molars, metallic brackets-conventional, not self ligating-on other teeth), in both the maxillary and the mandibular arch, placed at least two months before the patient is accepted into the study and no more than two years.

Non-extraction orthodontic treatment. Plaque-induced gingivitis: patients will be included if they have gingival bleeding on at least 30% of the sites examined using the criteria for bleeding of the Modified Simplified Gingival Index.

Exclusion Criteria:

- Active caries. Periodontitis. Tooth agenesis (excluding third molars). Syndromes and craniofacial deformities. Current use of electric toothbrush. More than two cervical and/or proximal fillings. Dental prostheses or dental implants. Smoking or use of other tobacco products. Antibiotics during the last 2 months. Medication that may result in gingival enlargement (e.g. anticonvulsants, immunosuppressants, calcium channel blockers).

Disabilities that might affect toothbrushing skills (manual dexterity, mental disabilities).

Peri-oral or intra-oral piercing. Cardiac or other medical condition that requires antibiotic prophylaxis for dental treatment.

Participation in other trials.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02699931
Other Study ID Numbers  ICMJE 2THBRUSH01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Demetrios Halazonetis, National and Kapodistrian University of Athens
Study Sponsor  ICMJE National and Kapodistrian University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Demetrios J Halazonetis National and Kapodistrian University of Athens
PRS Account National and Kapodistrian University of Athens
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP