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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
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Mariana Minatel Braga, University of Sao Paulo

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 Not Applicable

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  (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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

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



Primary Outcome Measures :
  1. progression of initial lesion caries [ Time Frame: 12 and 24 months ]

Secondary Outcome Measures :
  1. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Mariana M Braga, PhD 55 11 30917835 mmbraga@usp.br

Locations
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         
Sponsors and Collaborators
University of Sao Paulo
University of Copenhagen
Investigators
Principal Investigator: Mariana M Braga, PhD University of Sao Paulo

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.

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