Unsatisfactory or Defective Restoration of Tooth Clinical Trial
— REPAMLGOfficial title:
Longitudinal Results of a 10-Year Clinical Trial of Repair of Amalgam Restorations
Verified date | January 2014 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | Chile: Comité de Ética Científico |
Study type | Observational |
The aim of this prospective, randomized clinical trial was to assess the effectiveness of repair of localized clinical defects of amalgam restorations that were initially scheduled for replacement of restorations. A cohort of 20 patients with 40 (Class I and Class II) amalgam restorations, that presented one or more clinical features that deviated from the ideal (Bravo or Charlie) according to USPHS criteria, were randomly assigned to either, the repair or replacement group: A: repair n= 19 and B: replacement n=21. Two examiners who had calibration exercised evaluated the restorations at baseline and ten years after according to seven parameters: marginal occlusal adaptation, anatomic form, surface roughness, marginal staining, contact, secondary caries, and luster
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients having at least one tooth with a localized marginal defective amalgam restoration(s) that was clinically determined to be suitable for repair, according to USPHS criteria - patients with at least 20 teeth; - restorations in functional occlusion with at least one opposing natural tooth; - asymptomatic of post-operative sensitivity; - with occlusal and proximal contact areas; - patients older than 18 years; and - patients who agreed and signed the informed consent form for participating in the study. Exclusion Criteria: - patients with contraindications for regular dental treatment based on their medical history - patients who had special aesthetic needs that could not be solved by repair treatments - patients with xerostomia and/or patients who were taking medication that significantly decreased salivary flow - patients with high risk for caries - patients with psychiatric or physical diseases, which interfered with oral hygiene |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Chile | Eduardo Fernández Godoy | Santiago |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Chile,
Fernández EM, Martin JA, Angel PA, Mjör IA, Gordan VV, Moncada GA. Survival rate of sealed, refurbished and repaired defective restorations: 4-year follow-up. Braz Dent J. 2011;22(2):134-9. — View Citation
Martin J, Fernandez E, Estay J, Gordan VV, Mjör IA, Moncada G. Management of Class I and Class II Amalgam Restorations with Localized Defects: Five-Year Results. Int J Dent. 2013;2013:450260. doi: 10.1155/2013/450260. Epub 2013 Jan 28. — View Citation
Martin J, Fernandez E, Estay J, Gordan VV, Mjor IA, Moncada G. Minimal invasive treatment for defective restorations: five-year results using sealants. Oper Dent. 2013 Mar-Apr;38(2):125-33. doi: 10.2341/12-062C. Epub 2012 Jul 11. — View Citation
Moncada G, Fernández E, Martín J, Arancibia C, Mjör IA, Gordan VV. Increasing the longevity of restorations by minimal intervention: a two-year clinical trial. Oper Dent. 2008 May-Jun;33(3):258-64. doi: 10.2341/07-113. — View Citation
Moncada G, Martin J, Fernández E, Hempel MC, Mjör IA, Gordan VV. Sealing, refurbishment and repair of Class I and Class II defective restorations: a three-year clinical trial. J Am Dent Assoc. 2009 Apr;140(4):425-32. — View Citation
Moncada GC, Martin J, Fernandez E, Vildosola PG, Caamano C, Caro MJ, Mjor IA, Gordan VV. Alternative treatments for resin-based composite and amalgam restorations with marginal defects: a 12-month clinical trial. Gen Dent. 2006 Sep-Oct;54(5):314-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality amalgam restorations | 20 healthy voluteers with amalgam restorations , assesment of quality of amalgams by USPHS criterial | 10 years | Yes |
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