Replacement Clinical Trial
— REPCOMPOfficial title:
Can Repair Increase the Useful Life of Composite Resins? Clinical Trial: Triple-blind Controlled - 10 Year Follow-up
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 |
Objectives: The aim of this prospective, randomized, triple-blind cohort study was to assess the longevity of repairs to localized clinical defects in composite restorations that were initially scheduled to be treated with a restoration replacement Methods: 28 patients aged 18 to 80 years with 50 composite restorations were recruited.Restorations with clinically diagnosed secondary caries (Charlie) or undercontoured anatomical form defects (Bravo) were randomly assigned to the Repair (n = 25) or Replacement (n = 25) group, the quality of the restorations was scored according to the modified USPHS criteria. A Wilcoxon test was performed for comparisons between the same groups (CI=0.05). A Friedman test was utilized for multiple comparisons between different years of the same group.
Status | Completed |
Enrollment | 28 |
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 with localized marginal deficiencies of composite restorations that were clinically judged to be suitable for repair, sealing, or refurbishing according to USPHS criteria (Table 1). - Patients with more than 20 teeth. - Restorations in functional occlusions with an opposing natural tooth. - Asymptomatic restored tooth. - At least one proximal contact area with a neighbouring tooth. - Patients older than 18 years. - Patients who agreed and signed the consent form for participating in the study. - Area out of the restoration´s failure is in good condition. Exclusion Criteria: - Patients with contra-indications for regular dental treatment based on their medical history. - Patients with special aesthetic requirements that could not be solved by repair treatments. - Patients with xerostomia or taking medication that significantly decreased salivary flow. - Patients with a high risk of caries. - Patients with psychiatric or physical diseases, which interfered with oral hygiene. |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Chile | Eduardo Fernández Godoy | Santiango | Met |
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 composites restorations | up to 10 years | Yes |
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