Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth
NCT ID: NCT01477385
Last Updated: 2016-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
183 participants
INTERVENTIONAL
2012-01-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Resin Infiltration
Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing
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.
Dental Flossing
In this group, the patient will perform only mechanical removal of biofilm to floss daily.
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.
30% Silver Diammine Fluoride
30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing
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.
Dental Flossing
In this group, the patient will perform only mechanical removal of biofilm to floss daily.
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.
Oral Hygiene
Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo
Dental Flossing
In this group, the patient will perform only mechanical removal of biofilm to floss daily.
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.
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.
Interventions
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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.
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.
Dental Flossing
In this group, the patient will perform only mechanical removal of biofilm to floss daily.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
3 Years
17 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
University of Sao Paulo
OTHER
Responsible Party
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Mariana Minatel Braga
Phd
Principal Investigators
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Mariana M Braga, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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SDFtrials-01
Identifier Type: -
Identifier Source: org_study_id
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