An interventional study of Electric3D and Manual in Gingivitis and Dental Plaque, sponsored by National and Kapodistrian University of Athens. Completed at 1 site in Greece. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Prevention
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.
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.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 80 is above the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →National and Kapodistrian University of Athens is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
3D electric toothbrush (Oral-B) with orthodontic head.
Device: Electric3D
Manual orthodontic toothbrush (Oral-B).
Device: Manual
Oral-B 3D with orthodontic head
Oral-B orthodontic
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
Plan to share: Yes
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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National and Kapodistrian University of Athens