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

This study is currently recruiting participants.
Verified August 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Mariana Minatel Braga, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01501357
First received: December 20, 2011
Last updated: August 19, 2012
Last verified: August 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Sao Paulo:

Primary Outcome Measures:
  • dental caries [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • dental plaque [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   5 Years to 7 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mariana Minatel Braga, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01501357     History of Changes
Other Study ID Numbers: 001
Study First Received: December 20, 2011
Last Updated: August 19, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
caries
primary molars
plaque
toothbrushing

ClinicalTrials.gov processed this record on April 21, 2014