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Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control (toothbrushing)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Mariana Minatel Braga, University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501357
First Posted: December 29, 2011
Last Update Posted: August 21, 2012
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.
Information provided by (Responsible Party):
Mariana Minatel Braga, University of Sao Paulo
  Purpose
The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique compared with anteroposterior and biofilm removal and control of caries lesions in first permanent molars.

Condition Intervention
Caries Behavioral: modified toothbrush with multilevel filaments Behavioral: cross toothbrushing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control in Erupting Primary Permanent Molars - Randomized Clinical Trial Abbreviated Over 24 Months

Further study details as provided by Mariana Minatel Braga, University of Sao Paulo:

Primary Outcome Measures:
  • dental caries [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • dental plaque [ Time Frame: 24 months ]
    Dental plaque accumulation after short and long term analysis


Estimated Enrollment: 220
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: multilevel filaments toothbrush
Children will brush with anteroposterior toothbrushing and a modified toothbrush (multilevel filaments)
Behavioral: modified toothbrush with multilevel filaments
After the allocation of patients in this group they were instructed to brush their first molars erupt with the brushing technique anteroposterior.
Other Name: stages, oral b
Active Comparator: cross toothbrushing
Children will brush with cross toothbrushing.
Behavioral: cross toothbrushing
Children allocated to the group multi-bristled brush will be modified compared to the results of the group cross toothbrushing technique
Other Name: buccal-lingual technique

Detailed Description:
220 children between 5-7 years with at least one permanent molar erupting will be selected, with a maximum score of ICDAS 3. These children will be randomly allocated into two groups according to the technique adopted. The teeth will be evaluated by ICDAS, laser fluorescence (DIAGNOdent), QLF and subtraction radiography at baseline and after 15 days, 3, 6, 9,12,18,24 months.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • erupting primary permanent molar

Exclusion Criteria:

  • caries ( ICDAS 4,5 and 6),
  • enamel defects,
  • sealant,
  • restoration
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501357


Contacts
Contact: Mariana M Braga, PhD mmbraga@usp.br

Locations
Brazil
Universidade de São Paulo Recruiting
São Paulo, Brazil
Contact: Mariana M Braga, PhD    55 11 30917835    mmbraga@usp.br   
Sub-Investigator: Alessandra Reyes, DDS         
Principal Investigator: Fausto Mendes, PhD         
Sub-Investigator: Ana Carolina Leite, undergrad         
Sub-Investigator: Tatiane F Novaes, MSc         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Mariana M Braga, PhD University of Sao Paulo
  More Information

Responsible Party: Mariana Minatel Braga, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01501357     History of Changes
Other Study ID Numbers: 001
First Submitted: December 20, 2011
First Posted: December 29, 2011
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Mariana Minatel Braga, University of Sao Paulo:
caries
primary molars
plaque
toothbrushing