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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01501357
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received December 20, 2011
Last updated March 20, 2018
Start date July 2011
Est. completion date December 2014

Study information

Verified date March 2018
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 7 Years
Eligibility Inclusion Criteria:

- erupting primary permanent molar

Exclusion Criteria:

- caries ( ICDAS 4,5 and 6),

- enamel defects,

- sealant,

- restoration

Study Design


Related Conditions & MeSH terms


Intervention

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.
cross toothbrushing
Children allocated to the group multi-bristled brush will be modified compared to the results of the group cross toothbrushing technique

Locations

Country Name City State
Brazil Universidade de São Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary dental caries 24 months
Secondary dental plaque Dental plaque accumulation after short and long term analysis 24 months
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