Dental Restoration Failure Clinical Trial
— SEALCOMPOfficial title:
Increasing Longevity of Composite Restorations With Defective Margins With Sealants. Controlled Clinical Trial 10 Years Follow-up
Verified date | April 2014 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | Chile: Comité de Ética Científico |
Study type | Interventional |
A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%) and males (35%) with 80 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. All participants presented with marginal adaptation clinical features that deviated from the ideal and were rated Bravo according to the modified United States Public Health Service (USPHS) criteria for the sealing group and no treatment group. As a positive control were considered composites with alpha values in marginal adaptation. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile (Project PRI-ODO-0207). All of the patients signed informed-consent forms and completed registration form. The selection criteria are summarized below.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2013 |
Est. primary completion date | May 2003 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria. - 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 are older than 18 years. - Patients who agreed and signed a consent form for participating in the study. - Area out of the restoration´s failure is in good condition. Inclusion Criteria for Positive Control group : - Composite resins with alpha value in adaptation marginal criterial Exclusion Criteria: - Patients with contra-indications for regular dental treatment based on their medical history. - 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. - Patients with localized marginal deficiencies > 1 mm. and/or secondary caries adjacent to composite restorations , or major defects |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Chile | Facultad de Odontología Universidad de Chile | 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, 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 | Changes in quality of restorations | The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). Immediately after the treatment (baseline) and 10 years later, the examiners assessed the restorations independently by direct visual and tactile examination with mouth mirror number 5 and explorer number 23 (Hu Friedy Mfg. Co. Inc., Chicago, IL, USA) and indirectly by radiographic examination (bite wing). The four parameters examined were anatomic form, secondary caries, marginal staining and marginal adaptation. If the difference was recorded between the two examiners, and if they could not reach an agreement, a third clinician, who also underwent the calibration exercises (GM), made the final decision. | 1 year | Yes |
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