Unsatisfactory or Defective Restoration of Tooth Clinical Trial
Official title:
Longitudinal Results of a 10-Year Clinical Trial of Repair of Amalgam Restorations
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
Study Design A cohort of 20 patients between the ages of 18 to 80 years old (mean 26.5
years), female (58%) and male (42%), 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 modified United States Public Health Service USPHS criteria). All of them were
recruited at the Operative Dentistry Clinic at the Dental School, University of Chile. The
protocol was approved by the Institutional Research Ethics Committee of the Dental School at
the University of Chile (project PRI-ODO-0207), and all patients signed an informed consent
form and completed a registration form.
Treatment Group Criteria: 40 defective restorations were evaluated in accordance with the
modified USPHS criteria. Restorations with clinically diagnosed secondary caries (Charlie)
or under-contoured or over-contoured anatomic form defects and restorations with marginal
defects (Bravo) were randomly assigned (Random Number Generator, Microsoft Excel 97) to
either, the repair or replacement group. Diagnosis of active secondary caries was done
according to Ekstrand's criteria 31.
The groups were labeled A: repair n= 19 (Class I n=8 and Class II n=11) and B: replacement
n=21 (Class I n=9 and Class II n=12).
Restorations Assessment and Outcome Measurements. The quality of the restorations was scored
according to the modified USPHS criteria (Table 1) 32. Two examiners underwent calibration
exercises (JM and EF, Cohen's Kappa inter-examiner coefficient 0.74 at baseline and 0.87 at
ten years). The examiners assessed the restorations independently by direct visual and
tactile examination (mouth mirror, number 5, Hu Friedy Mfg. Co. Inc., Chicago, IL, USA, and
explorer, number 23, Hu Friedy) and indirectly by radiographic examination (Bite Wing) at
baseline (immediately after treatment) and 10 years after treatment. The seven examined
parameters were marginal occlusal adaptation (MA), anatomic form (A), surface roughness (R),
Marginal staining (MS), occlusal contact (O), secondary caries (SC), and luster (L) (Table
1). If any difference was recorded between the two examiners, and if they did not reach an
agreement, a third clinician, who also underwent calibration exercises (GM), made the final
decision.
Treatment Group
A. Repair The clinicians (PV and CM) used Carbide burs (330-010 Komet, Brasseler GmbH Co.
Postfach 160.32631, Lemgo, Germany) to explore the defective margin, carious lesion or
anatomic form of the restorations. Part of the restorative material adjacent to the defect
was removed as an exploratory proceedure thus allowing a proper evaluation and subsequent
diagnosis of the extent of the defect. Provided that the defect was limited and localized,
the clinician then removed any defective tooth tissue. Mechanical retention was employed
inside the existing AM restoration. Rubber dam isolation was used for this procedure. Repair
of the restorations was carried out with a dispersed-phased amalgam (Original D, Wyckle
Research Inc, Carson City, NV, USA).
B. Replacement The clinicians totally removed and replaced the defective restorations. After
completing the cavity preparations, the tooth was restored with a new AM (Original D).
Bonding agents and/or liners underneath the amalgam restorations were not used in this
trial. Rubber dam isolation was used for all restorative treatments. .
Patients were recalled after four and ten years after the restoration were placed for
clinical assessment by the same examiners, applying the same criteria used at baseline.
Failed restorations were removed from the study and treated according to their diagnosed
needs.
Statistical analysis The ordinal dependent variable was changed in level of the modified
USPHS criteria from the baseline value. The assigned score of each restoration reflected the
worst result for any of the parameters. The results of each group in terms of degradation or
upgrade were analyzed by Friedman range non-parametric test to compare the pre and
postoperative conditions. Additionally, the performance of all groups was contrasted using
the Mann Whitney test to determine the differences between the upgrade and downgrade of the
restoration´s quality. The statistical significance was set at 95%, α=0.05 and β=0.80,
SPSS15.0 (SPSS Inc, Chicago, IL) was used for statistical analysis.
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Observational Model: Case Control, Time Perspective: Prospective
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