NCT01477385

Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth

Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth: a Randomized Placebo-controlled Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The sample will be comprised of 141 patients between 3 to 10 year-old and 504 proximal surfaces of 12-to-17-year-old adolescents, who present at least one proximal surface with initial caries lesion. Patients will be randomly allocated to treatments, according to the technique to be employed: (I) resin infiltration (II) 30% diamine silver fluoride, (III) just daily flossing by the patient. All subjects will receive placebo treatments performed in other groups. The teeth will be evaluated by clinical and radiographic exams at baseline and after 1, 3, 6, 12, 18 and 24 months. In 1, 3 and 18 months will just be evaluated aspects related to the biofilm.

Conditions

• Dental Caries
• Compliance Behavior

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2011-11-22
• Last updated: 2016-05-04

Locations

1 site across 1 country: Brazil