We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099551
Recruitment Status : Unknown
Verified March 2017 by Faculty Sao Leopoldo Mandic Campinas.
Recruitment status was:  Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Faculty Sao Leopoldo Mandic Campinas

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of the present study was to evaluate the efficacy of two different toothbrushes (manual and sonic) on plaque control

Condition or disease Intervention/treatment Phase
Plaque Gingivitis Device: Group using manual toothbrush Curaprox 5460 Ultra Soft Device: Group using sonic toothbrush Edel White Phase 4

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Randomized Trial to Evaluate the Efficacy of Two Different Toothbrushes on Plaque Control
Actual Study Start Date : December 2016
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Manual Toothbrush users
Group using manual toothbrush Curaprox 5460 Ultra Soft
 Device: Group using manual toothbrush Curaprox 5460 Ultra Soft
Manual toothbrush usage with Bass technique twice a day during 2 minutes
Active Comparator: Sonic Toothbrush users
Group using sonic toothbrush Edel White
 Device: Group using sonic toothbrush Edel White
Sonic toothbrush usage twice a day during 2 minutes


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Silness & Löe Gingival Index [ Time Frame: 6 months ]
    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

  2. Turesky Modification of the Quigley Hein Plaque Index [ Time Frame: 6 months ]
    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

  3. Community periodontal index [ Time Frame: 6 months ]
    0 = No periodontal disease; 1 = Bleeding on probing; 2 = Calculus with plaque seen or felt by probing.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:
Castro CO, Katiane SO, Carvalho RB, Garbin CAS, Bueno RN. Education and prevention programs for oral health in schools: a critical analysis of national publications. OdontolClín-Cient 2012 Jan-Mar; 11(1): 35-9.
Baccareli JC, Ribeiro MC. Sensibilidade dos Lactobacillus a anti-sépticos bucais. Rev Cienc Med, Campinas 2000; 9(3):99-104.
Chalub LLF, Péret ACA. Desempenho do Índice Periodontal Comunitário (CPI) na determinação da condição periodontal: enfoque no exame parcial. Revista do Arquivo Brasileiro de Odontologia. 2010;6(3):155-62.
Kinane DF, Berglundh T, Lindhe J. Patogênese da Pariodontite. In: Lindhe J, Lang N. P, Karring T. Tratado de Periodontia Clínica e Implantologia Oral. 5a ed. Rio de Janeiro: Guanabara Koogan; 2010. P.271-91.
Lopes MWF, Gusmão ES, Alves RV, Cimões R. The Impacto f Chronic Periodontitis on Quality of Life in Brazilian Subjects. Acta Stomatol Croat. 2009 June;43(2):89-98.
Marinho BVS, Araújo ACS. Uso dos enxaguatórios bucais sobre a gengivite e biofilme dental. International Journal of Dentistry 2007; 6(4):124-31.
Papapanou PN, Lindhe J. Epidemiologia das doenças periodontais. In: Lindhe J, Lang NP, Karring T. Tratado de Periodontia Clínica e Implantologia Oral. 5a ed. Rio de Janeiro: Guanabara Koogan; 2010. p.123-70.
Pedrazzi V; Souza, SLS, Oliveira RR; Cimões R; Gusmão ES. Métodos mecânicos para o controle do biofilme dentário supragengival. Periodontia;19(3):26-33, 2009.
Rufasto Goche K, Saavedra Alvarado B. Aplicación de un programa educativo en salud oral en adolescentes de una institución educativa peruana. Rev Estomatol Herediana 2012 abr-jun; ;22(2):82-90.
Soares D, Andrade A, Pinto AR, Seabra M, Macho V. Doenças da gengiva e periodonto em crianças e adolescentes. Acta Pediatr Port 2009 40(1):23-29.
Saba-Chujfi E, Silva ECQ, Sarian R. Avaliação dos métodos de motivação/educação em higiene bucal. RGO. 1992; 40:87-90.
World Health Organization. Health Promotion: A Discussion Document on the Concept and Principles. Copenhagen: WHO Regional Office for Europe, 1984
World Health Organization. Oral health surveys: basic methods. 5th Ed. Geneva: World Health Organization; 2013.

Layout table for additonal information
Responsible Party: Faculty Sao Leopoldo Mandic Campinas
ClinicalTrials.gov Identifier: NCT03099551    
Other Study ID Numbers: 1.672.795
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Faculty Sao Leopoldo Mandic Campinas:
Plaque
oral hygiene
gingivitis
sonic toothbrush
manual toothbrush
Additional relevant MeSH terms:
Layout table for MeSH terms
Gingivitis
Infections
Gingival Diseases
 Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases