NCT01477385

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

6.8 years

First QC Date

November 16, 2011

Last Update Submit

May 3, 2016

Conditions

Dental CariesCompliance Behavior

Keywords

dental cariesprimary teethpermanent teethsilver diamine fluoride

Outcome Measures

Primary Outcomes (1)

  • progression of initial lesion caries

    12 and 24 months

Secondary Outcomes (1)

  • approximal plaque reduction

    1, 3, 6, 12, 18 and 24 months

Study Arms (3)

Resin Infiltration

ACTIVE COMPARATOR

Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing

Procedure: Resin InfiltrationProcedure: Dental FlossingProcedure: 30% Silver Diammine Fluoride Placebo

30% Silver Diammine Fluoride

EXPERIMENTAL

30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing

Procedure: 30% Silver Diammine FluorideProcedure: Dental FlossingProcedure: Resin Infiltration Placebo

Oral Hygiene

ACTIVE COMPARATOR

Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo

Procedure: Dental FlossingProcedure: Resin Infiltration PlaceboProcedure: 30% Silver Diammine Fluoride Placebo

Interventions

Resin InfiltrationPROCEDURE

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.

Also known as: Icon
Resin Infiltration
30% Silver Diammine FluoridePROCEDURE

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.

Also known as: Cariestop
30% Silver Diammine Fluoride
Dental FlossingPROCEDURE

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

Also known as: Oral hygiene
30% Silver Diammine FluorideOral HygieneResin Infiltration
Resin Infiltration PlaceboPROCEDURE

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.

Also known as: Icon Placebo
30% Silver Diammine FluorideOral Hygiene
30% Silver Diammine Fluoride PlaceboPROCEDURE

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.

Also known as: Cariestop Placebo
Oral HygieneResin Infiltration

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, São Paulo, 05508-000, Brazil

RECRUITING

Related Publications (2)

  • Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009a;76(1):28-33. Braga MM, Morais CC, Nakama RC, Leamari VM, Siqueira WL, Mendes FM. In vitro performance of methods of approximal caries detection in primary molars. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009b;108(4):e35-41. Cagetti MG, Campus G, Sale S, Cocco F, Strohmenger L, Lingström P. Association between interdental plaque acidogenicity and caries risk at surface level: a cross sectional study in primary dentition. Int J Paediatr Dent. 2011;21(2):119-25. Ekstrand KR, Bakhshandeh A, Martignon S. Treatment of proximal superficial caries lesions on primary molar teeth with resin infiltration and fluoride varnish versus fluoride varnish only: efficacy after 1 year. Caries Res. 2010;44(1):41-6.

    BACKGROUND

  • Mattos-Silveira J, Floriano I, Ferreira FR, Vigano ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.

    PMID: 25409545DERIVED

MeSH Terms

Conditions

Dental CariesPatient Compliance

Interventions

icon infiltrantsilver diamine fluorideDental Devices, Home CareOral Hygiene

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Dental EquipmentDentistryPreventive DentistryEquipment and SuppliesHygieneTherapeutics

Study Officials

  • Mariana M Braga, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana M Braga, PhD

CONTACT

55 11 30917835mmbraga@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 22, 2011

Study Start

January 1, 2012

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

BR(1)