Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth
NCT01477385 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183
Last updated 2016-05-04
Summary
This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment of clinically caries lesions in enamel, with radiographic image restricted to the enamel or the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth. It also aims to compare it to the resin infiltration and to the control of proximal biofilm through the oral hygiene.
Conditions
- Dental Caries
- Compliance Behavior
Interventions
- PROCEDURE
-
Resin Infiltration
After cleaning the proximal surface with caries lesion, it will be performed the local infiltration anesthesia and adaptation of the rubber dam. The adjacent tooth will be protected by plastic or metal strip. Hydrochloric acid 15% will be applied on the lesion, which will be washed and dried. The surface should be dried by applying 95% ethanol and air-way syringe. The resin infiltration (Icon, DMG) will be applied on the lesion. The resin will be polymerized and applied again and polymerized.
- PROCEDURE
-
30% Silver Diammine Fluoride
It will be cleaned like group I. Soft tissues will be protected with petroleum jelly. The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s.
- PROCEDURE
-
Dental Flossing
In this group, the patient will perform only mechanical removal of biofilm to floss daily.
- PROCEDURE
-
Resin Infiltration Placebo
In this group, the patient will be held only inserting the rubber dam and applied sterile water as a substitute for acid, ethanol and resin infiltration.
- PROCEDURE
-
30% Silver Diammine Fluoride Placebo
Soft tissues will be protected with petroleum jelly. The patient will receive sterile water application with a disposable microbrush for 3m. Then the surface will be washed for 30s.
Sponsors & Collaborators
-
University of Copenhagen
collaborator OTHER -
University of Sao Paulo
lead OTHER
Principal Investigators
-
Mariana M Braga, PhD · University of Sao Paulo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2018-10-31
- Completion
- 2018-10-31
Countries
- Brazil
Study Locations
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