NCT02699931

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 12 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingivitis
• Dental Plaque

Interventions

Type	Name	Description
DEVICE	Electric3D	Oral-B 3D with orthodontic head
DEVICE	Manual	Oral-B orthodontic

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2016-03-07
• Last updated: 2019-06-06

Locations

1 site across 1 country: Greece