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

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01477385

Collaborator

University of Copenhagen (Other)

183

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries Compliance Behavior	Procedure: Resin Infiltration Procedure: 30% Silver Diammine Fluoride Procedure: Dental Flossing Procedure: Resin Infiltration Placebo Procedure: 30% Silver Diammine Fluoride Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

183 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Resin Infiltration Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing	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. Other Names: Icon Procedure: Dental Flossing In this group, the patient will perform only mechanical removal of biofilm to floss daily. Other Names: Oral hygiene 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. Other Names: Cariestop Placebo
Experimental: 30% Silver Diammine Fluoride 30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing	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. Other Names: Cariestop Procedure: Dental Flossing In this group, the patient will perform only mechanical removal of biofilm to floss daily. Other Names: Oral hygiene 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. Other Names: Icon Placebo
Active Comparator: Oral Hygiene Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo	Procedure: Dental Flossing In this group, the patient will perform only mechanical removal of biofilm to floss daily. Other Names: Oral hygiene 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. Other Names: Icon Placebo 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. Other Names: Cariestop Placebo

Arm

Intervention/Treatment

Active Comparator: Resin Infiltration

Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing

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.

Other Names:

Icon

Procedure: Dental Flossing

In this group, the patient will perform only mechanical removal of biofilm to floss daily.

Other Names:

Oral hygiene

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.

Other Names:

Cariestop Placebo

Experimental: 30% Silver Diammine Fluoride

30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing

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.

Other Names:

Cariestop

Procedure: Dental Flossing

In this group, the patient will perform only mechanical removal of biofilm to floss daily.

Other Names:

Oral hygiene

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.

Other Names:

Icon Placebo

Active Comparator: Oral Hygiene

Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo

Procedure: Dental Flossing

In this group, the patient will perform only mechanical removal of biofilm to floss daily.

Other Names:

Oral hygiene

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.

Other Names:

Icon Placebo

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.

Other Names:

Cariestop Placebo

Outcome Measures

Primary Outcome Measures

progression of initial lesion caries [12 and 24 months]

Secondary Outcome Measures

approximal plaque reduction [1, 3, 6, 12, 18 and 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary teeth: distal surface of the first molar, mesial surface of the second molar and distal surface of the second molar (when the first permanent molar is present) with initial caries lesion (ICDAS 1, 2 or 3).
Permanent teeth: distal surface of the first premolar, mesial surface of the second premolar, distal surface of the second premolar, mesial surface of the first molar, distal surface of the first molar and mesial surface of the second molar with initial caries lesion (ICDAS 1, 2 or 3).

Exclusion Criteria:

Mesial surface of the first primary molar/premolar by the smaller contact with the distal surface of the canines. It will be also excluded the surfaces that show proximal restorations, sealants, cavities, defects, as well as intact teeth.