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

Primary Purpose

Gingivitis, Dental Plaque

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Electric3D

Manual

About this trial

This is an interventional prevention trial for Gingivitis

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Department of Orthodontics, School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electric3D

Manual

Arm Description

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

Manual orthodontic toothbrush (Oral-B).

Outcomes

Primary Outcome Measures

Modified Silness and Löe plaque index

Modified Full mouth plaque score

Modified Gingival index

Modified Simplified Gingival index

Secondary Outcome Measures

Full Information

NCT ID

NCT02699931

First Posted

March 1, 2016

Last Updated

June 5, 2019

Sponsor

National and Kapodistrian University of Athens

1. Study Identification

Unique Protocol Identification Number

NCT02699931

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

April 2019 (Actual)

Study Completion Date

April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National and Kapodistrian University of Athens

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis, Dental Plaque

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electric3D

Arm Type

Experimental

Arm Description

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

Arm Title

Manual

Arm Type

Active Comparator

Arm Description

Manual orthodontic toothbrush (Oral-B).

Intervention Type

Device

Intervention Name(s)

Electric3D

Intervention Description

Oral-B 3D with orthodontic head

Intervention Type

Device

Intervention Name(s)

Manual

Intervention Description

Oral-B orthodontic

Primary Outcome Measure Information:

Title

Modified Silness and Löe plaque index

Time Frame

Baseline and monthly for 3 months

Title

Modified Full mouth plaque score

Time Frame

Baseline and monthly for 3 months

Title

Modified Gingival index

Time Frame

Baseline and monthly for 3 months

Title

Modified Simplified Gingival index

Time Frame

Baseline and monthly for 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Demetrios J Halazonetis

Organizational Affiliation

National and Kapodistrian University of Athens

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Orthodontics, School of Dentistry

City

Athens

ZIP/Postal Code

11527

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

34752255

Citation

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.

Results Reference

derived

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

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