Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

Sebastian Zingler

Status: Completed

Conditions: Dental Plaque; Gingivitis

Treatments: Device: manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®); Device: manual toothbrush (elmex® Inter X medium toothbrush); Device: sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)

Study type: Interventional

Funder types: Other

Identifiers

NCT00681135

ZKL-08-MHW

Details and patient eligibility

About

The purpose of this study is to determine whether the use of a sonic toothbrush alone is more effective than two other toothbrushing protocols on dental plaque elimination in patients with fixed orthodontic appliances.

Enrollment: 118 patients

Sex: All

Ages: 11 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• no systemic diseases
• orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)
• informed consent

Exclusion criteria

• presence of caries lesion
• antibiotic therapy within the previous 6 months
• diagnosis of early onset periodontitis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

118 participants in 4 patient groups

1

Experimental group

Treatment:

Device: sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)

2

Experimental group

Treatment:

Device: manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)

3

Experimental group

Treatment:

Device: manual toothbrush (elmex® Inter X medium toothbrush)

Device: manual toothbrush (elmex® Inter X medium toothbrush)

4

Active Comparator group

Treatment:

Device: manual toothbrush (elmex® Inter X medium toothbrush)

Device: manual toothbrush (elmex® Inter X medium toothbrush)