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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resin Infiltration | Active Comparator | Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing |
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| 30% Silver Diammine Fluoride | Experimental | 30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing |
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| Oral Hygiene | Active Comparator | Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin Infiltration | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| progression of initial lesion caries | 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| approximal plaque reduction | 1, 3, 6, 12, 18 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariana M Braga, PhD | Contact | 55 11 30917835 | mmbraga@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Mariana M Braga, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade de São Paulo | Recruiting | São Paulo | São Paulo | 05508-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 25409545 | Derived | 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. |
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| 30% Silver Diammine Fluoride | Procedure | 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. |
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| Dental Flossing | Procedure | In this group, the patient will perform only mechanical removal of biofilm to floss daily. |
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| Resin Infiltration Placebo | Procedure | 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. |
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| 30% Silver Diammine Fluoride Placebo | Procedure | 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. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C578177 | icon infiltrant |
| C024633 | silver diamine fluoride |
| D003742 | Dental Devices, Home Care |
| D009910 | Oral Hygiene |
| ID | Term |
|---|---|
| D003748 | Dental Equipment |
| D003813 | Dentistry |
| D011313 | Preventive Dentistry |
| D004864 | Equipment and Supplies |
| D006920 | Hygiene |
| D013812 | Therapeutics |
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