Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth
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ClinicalTrials.gov Identifier: NCT01477385 |
Recruitment Status
:
Recruiting
First Posted
: November 22, 2011
Last Update Posted
: May 4, 2016
|
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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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | January 2012 |
Estimated Primary Completion Date : | October 2018 |
Estimated Study Completion Date : | October 2018 |

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 Name: Icon
Procedure: Dental Flossing
In this group, the patient will perform only mechanical removal of biofilm to floss daily.
Other Name: 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 Name: 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 Name: Cariestop
Procedure: Dental Flossing
In this group, the patient will perform only mechanical removal of biofilm to floss daily.
Other Name: 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 Name: 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 Name: 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 Name: 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 Name: Cariestop Placebo
|
- progression of initial lesion caries [ Time Frame: 12 and 24 months ]
- approximal plaque reduction [ Time Frame: 1, 3, 6, 12, 18 and 24 months ]

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Ages Eligible for Study: | 3 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477385
Contact: Mariana M Braga, PhD | 55 11 30917835 | mmbraga@usp.br |
Brazil | |
Universidade de São Paulo | Recruiting |
São Paulo, Brazil, 05508-000 | |
Contact: Mariana Braga, PhD 55 11 30917835 mmbraga@usp.br | |
Principal Investigator: Fausto Mendes, PhD | |
Sub-Investigator: Juliana Silveira, DDS | |
Sub-Investigator: Fernanda Ferreira, DDS |
Principal Investigator: | Mariana M Braga, PhD | University of Sao Paulo |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mariana Minatel Braga, Phd, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT01477385 History of Changes |
Other Study ID Numbers: |
SDFtrials-01 |
First Posted: | November 22, 2011 Key Record Dates |
Last Update Posted: | May 4, 2016 |
Last Verified: | May 2016 |
Keywords provided by Mariana Minatel Braga, University of Sao Paulo:
dental caries primary teeth permanent teeth silver diamine fluoride |
Additional relevant MeSH terms:
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs |