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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01477385 on ClinicalTrials.gov