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

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ClinicalTrials.gov Identifier: NCT01501357
Recruitment Status : Unknown
Verified August 2012 by Mariana Minatel Braga, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : December 29, 2011
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Caries Behavioral: modified toothbrush with multilevel filaments Behavioral: cross toothbrushing

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
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
Study Start Date : July 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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


Eligibility Criteria

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 Posted: December 29, 2011    Key Record Dates
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