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.

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries; Compliance Behavior
• Intervention / Treatment: Procedure: Resin Infiltration; Procedure: Dental Flossing; Procedure: 30% Silver Diammine Fluoride Placebo; Procedure: 30% Silver Diammine Fluoride; Procedure: Resin Infiltration Placebo

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 Type: Interventional
• Enrollment (Anticipated): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05508-000
    • Recruiting
    • Universidade de São Paulo
    • Contact: Mariana Braga, PhD; Phone Number: 55 11 30917835; Email: mmbraga@usp.br
    • Principal Investigator: Fausto Mendes, PhD
    • Sub-Investigator: Juliana Silveira, DDS
    • Sub-Investigator: Fernanda Ferreira, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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: 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; 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: 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: 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression of initial lesion caries	12 and 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
approximal plaque reduction	1, 3, 6, 12, 18 and 24 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Mariana M Braga, PhD, University of Sao Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): May 4, 2016
• Last Update Submitted That Met QC Criteria: May 3, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: silver diamine fluoride; dental caries; primary teeth; permanent teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: SDFtrials-01