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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03099551
• Other study ID #: 1.672.795
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 28, 2017
• Last updated: March 31, 2017
• Start date: December 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2017
• Source: Faculty Sao Leopoldo Mandic Campinas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Plaque

Intervention

Device:
• Group using manual toothbrush Curaprox 5460 Ultra Soft
Manual toothbrush usage with Bass technique twice a day during 2 minutes
• Group using sonic toothbrush Edel White
Sonic toothbrush usage twice a day during 2 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Sao Leopoldo Mandic Campinas

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Silness & Löe Gingival Index	0 = 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	6 months
Primary	Turesky Modification of the Quigley Hein Plaque Index	0 = 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	6 months
Primary	Community periodontal index	0 = No periodontal disease; 1 = Bleeding on probing; 2 = Calculus with plaque seen or felt by probing.	6 months

External Links

•   Brazil. Ministry of Health. Healthcare Department/Health Inspection Office. Department of Basic Healthcare. General Management of Oral Health. SBBrasil: principal results. Brasília: Ministry of Health; 2010.