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Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control

Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03099551
Enrollment
56
Registered
2017-04-04
Start date
2016-12-31
Completion date
2017-06-30
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Plaque

Keywords

Plaque, oral hygiene, gingivitis, sonic toothbrush, manual toothbrush

Brief summary

The aim of the present study was to evaluate the efficacy of two different toothbrushes (manual and sonic) on plaque control

Detailed description

A parallel randomized clinical trial, examiner-blind, was conducted involving 56 patients with ages from 15 to 20, all students of CAMP (Centro de Formação e Integração Social), in the city of São Bernardo do Campo, state of São Paulo, Brazil. Randomization: the subjects were randomly allocated to two different groups (A for the manual toothbrush and B for the sonic toothbrush) by removing from an urn a paper with their respective group. Silness & Löe Gingival Index, the Turesky Modification of the Quigley Hein Plaque Index and the Community Periodontal Index were evaluated at baseline and after 3 and 6 months.

Interventions

DEVICEGroup using manual toothbrush Curaprox 5460 Ultra Soft

Manual toothbrush usage with Bass technique twice a day during 2 minutes

DEVICEGroup using sonic toothbrush Edel White

Sonic toothbrush usage twice a day during 2 minutes

Sponsors

Faculty Sao Leopoldo Mandic Campinas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
15 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects had to be in generally good health, and possessing a minimum of 20 permanent natural teeth, excluding third molars.

Exclusion criteria

* Subjects were excluded if they had fixed orthodontic appliances, advanced periodontal disease, limited manual dexterity, active caries, medical conditions limiting their salivary function or immunological condition, and if they were smokers.

Design outcomes

Primary

MeasureTime frameDescription
Silness & Löe Gingival Index6 months0 = Normal gingiva; 1 = Mild inflammation - slight change in colour, slight oedema. No bleeding on probing; 2 = Moderate inflammation - redness, oedema and glazing; bleeding on probing; 3 = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding
Turesky Modification of the Quigley Hein Plaque Index6 months0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth; 3 = A band of plaque wider than one mm but covering less than one third of the crown of the tooth; 4 = Plaque covering at least one-third but less than two-thirds of the crown of the tooth; 5 = Plaque covering two-thirds or more of the crown of the tooth
Community periodontal index6 months0 = No periodontal disease; 1 = Bleeding on probing; 2 = Calculus with plaque seen or felt by probing.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026