Back to resultsTreatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth
Primary Purpose
Dental Caries, Compliance Behavior
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resin Infiltration
30% Silver Diammine Fluoride
Dental Flossing
Resin Infiltration Placebo
30% Silver Diammine Fluoride Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring dental caries, primary teeth, permanent teeth, silver diamine fluoride
Eligibility 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.
Sites / Locations
- Universidade de São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Resin Infiltration
30% Silver Diammine Fluoride
Oral Hygiene
Arm Description
Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing
30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing
Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo
Outcomes
Primary Outcome Measures
progression of initial lesion caries
Secondary Outcome Measures
approximal plaque reduction
Full Information
NCT ID
NCT01477385
First Posted
November 16, 2011
Last Updated
May 3, 2016
Sponsor
University of Sao Paulo
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01477385
Brief Title
Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth
Official Title
Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth: a Randomized Placebo-controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
University of Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Compliance Behavior
Keywords
dental caries, primary teeth, permanent teeth, silver diamine fluoride
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resin Infiltration
Arm Type
Active Comparator
Arm Description
Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing
Arm Title
30% Silver Diammine Fluoride
Arm Type
Experimental
Arm Description
30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing
Arm Title
Oral Hygiene
Arm Type
Active Comparator
Arm Description
Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo
Intervention Type
Procedure
Intervention Name(s)
Resin Infiltration
Other Intervention Name(s)
Icon
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
30% Silver Diammine Fluoride
Other Intervention Name(s)
Cariestop
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dental Flossing
Other Intervention Name(s)
Oral hygiene
Intervention Description
In this group, the patient will perform only mechanical removal of biofilm to floss daily.
Intervention Type
Procedure
Intervention Name(s)
Resin Infiltration Placebo
Other Intervention Name(s)
Icon Placebo
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
30% Silver Diammine Fluoride Placebo
Other Intervention Name(s)
Cariestop Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression of initial lesion caries
Time Frame
12 and 24 months
Secondary Outcome Measure Information:
Title
approximal plaque reduction
Time Frame
1, 3, 6, 12, 18 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana M Braga, PhD
Phone
55 11 30917835
Email
mmbraga@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana M Braga, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Braga, PhD
Phone
55 11 30917835
Email
mmbraga@usp.br
First Name & Middle Initial & Last Name & Degree
Fausto Mendes, PhD
First Name & Middle Initial & Last Name & Degree
Juliana Silveira, DDS
First Name & Middle Initial & Last Name & Degree
Fernanda Ferreira, DDS
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
25409545
Citation
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.
Results Reference
derived
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Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth
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