NCT02699931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

March 1, 2016

Last Update Submit

June 5, 2019

Conditions

GingivitisDental Plaque

Outcome Measures

Primary Outcomes (4)

  • Modified Silness and Löe plaque index

    Baseline and monthly for 3 months

  • Modified Full mouth plaque score

    Baseline and monthly for 3 months

  • Modified Gingival index

    Baseline and monthly for 3 months

  • Modified Simplified Gingival index

    Baseline and monthly for 3 months

Study Arms (2)

Electric3D

EXPERIMENTAL

3D electric toothbrush (Oral-B) with orthodontic head.

Device: Electric3D

Manual

ACTIVE COMPARATOR

Manual orthodontic toothbrush (Oral-B).

Device: Manual

Interventions

Electric3DDEVICE

Oral-B 3D with orthodontic head

Electric3D
ManualDEVICE

Oral-B orthodontic

Manual

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, School of Dentistry

Athens, 11527, Greece

Location

Related Publications (1)

  • Mylonopoulou IM, Pepelassi E, Madianos P, Halazonetis DJ. A randomized, 3-month, parallel-group clinical trial to compare the efficacy of electric 3-dimensional toothbrushes vs manual toothbrushes in maintaining oral health in patients with fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2021 Nov;160(5):648-658. doi: 10.1016/j.ajodo.2021.02.016.

    PMID: 34752255DERIVED

MeSH Terms

Conditions

GingivitisDental Plaque

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Officials

  • Demetrios J Halazonetis

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 7, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

June 6, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Locations

GR(1)