Clinical trial NCT02699931: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Dental Plaque
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Modified Silness and Löe plaque index
timeFrame: Baseline and monthly for 3 months
measure: Modified Full mouth plaque score
timeFrame: Baseline and monthly for 3 months
measure: Modified Gingival index
timeFrame: Baseline and monthly for 3 months
measure: Modified Simplified Gingival index
timeFrame: Baseline and monthly for 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Orthodontics, School of Dentistry
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Demetrios J Halazonetis
role: PRINCIPAL_INVESTIGATOR
References:
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.