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:
University of Sao Paulo
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
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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 June 17, 2013