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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

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.

Condition or disease Intervention/treatment Phase
Gingivitis Dental Plaque Device: Electric3D Device: Manual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Electric3D
3D electric toothbrush (Oral-B) with orthodontic head.
Device: Electric3D
Oral-B 3D with orthodontic head

Active Comparator: Manual
Manual orthodontic toothbrush (Oral-B).
Device: Manual
Oral-B orthodontic




Primary Outcome Measures :
  1. Modified Silness and Löe plaque index [ Time Frame: Baseline and monthly for 3 months ]
  2. Modified Full mouth plaque score [ Time Frame: Baseline and monthly for 3 months ]
  3. Modified Gingival index [ Time Frame: Baseline and monthly for 3 months ]
  4. Modified Simplified Gingival index [ Time Frame: Baseline and monthly for 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


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): NCT02699931


Locations
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Greece
Department of Orthodontics, School of Dentistry
Athens, Greece, 11527
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Demetrios J Halazonetis National and Kapodistrian University of Athens
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Responsible Party: Demetrios Halazonetis, Assoc. Prof., National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT02699931    
Other Study ID Numbers: 2THBRUSH01
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases