Diastema Clinical Trial
Official title:
A Prospective 4-year Clinical Study Evaluating Two Resin Composites on Diastema Closure and Reshaping
The aim of this study was to evaluate the clinical performances of nano-hybrid resin
composite systems used for anterior diastema closure and tooth reshaping at 4 years in
service using FDI Criteria.
Twenty-three patients with diastema problem were enrolled. Nano-hybrid resin composites to
be used on each patient were randomly selected. Thirty-seven teeth (10 patients) were
restored with Filtek-Z550 (3M/ESPE) in combination with Adper™ Single Bond 2 (3M/ESPE) in
Group 1; whereas 39 teeth (13 patients) were restored with Charisma-Diamond (Heraeus Kulzer)
in combination with Gluma2 Bond (Heraeus Kulzer) in Group 2, by two operators. Esthetic,
functional and biological properties of the restorations were evaluated at baseline, 1-4
years using FDI Criteria establishing a score-range of 1-5. The data were evaluated using
the Fisher's Chi-Square (p=0.05).
The aim of this study was to evaluate the clinical performances of nano-hybrid resin
composite systems used for anterior diastema closure and tooth reshaping at 4 years in
service using FDI Criteria.
The study protocol was approved by the Ethical Committee of Hacettepe University, Ankara,
Turkey and the Ethical Committee of Ministry of Health (protocol HEK KA-14004). A total of
23 patients (6 male, 17 female, mean age: 31.27) with maxillary anterior midline or
multi-diastema problem received 76 direct composite resin restorations.
The teeth to be restored were first cleaned with pumice-water slurry using a rubber cup. The
appropriate shade of restorative material was selected using a standard VITAPAN® Classic
shade guide and initial intraoral photographs were taken. Teeth were then isolated using
cotton rolls and Mylar strips were placed with the help of wedges interproximally to achieve
a smooth and overhang free restoration outline in the cervical area and to form final
restorations. The surfaces to be restored were etched using 35% phosphoric or
orthophosphoric acid for 30 s according to the restorative system used. The etched surfaces
were rinsed and dried. Nano-hybrid resin composite systems to be used on each patient were
randomly selected. Thirty seven teeth of 10 patients were restored with Filtek-Z550
(3M/ESPE, St. Paul, MN, USA) in combination with Adper™ Single Bond 2 (3M/ESPE, St. Paul,
MN, USA) etch&rinse adhesive; whereas 39 teeth of 13 patients were restored with
Charisma-Diamond (Heraeus Kulzer, GmbH, Germany) in combination with Gluma2 Bond (Heraeus
Kulzer, GmbH, Germany) etch&rinse adhesive by two operators. Materials were used according
to the manufacturers' instructions. Two calibrated observers who were blinded to the
objective of this study performed the evaluations. For maximum validity, the observers were
calibrated by using the web-based training and calibration tool www.e-calib.info recommended
by FDI. Both observers evaluated the esthetic, functional and biological properties of the
restorations independently at baseline, 1-2-3 and 4 years using FDI Criteria establishing a
score-range of 1-5 (1-Clinically excellent/very good, 2-Clinically good, 3-Clinically
sufficient/satisfactory, 4-Clinically unsatisfactory and 5-Clinically poor). After data
collection, in case of discrepancies in scoring, restorations were evaluated again, a
consensus was reached and this was accepted as the final score.
Statistical analysis was performed with SPSS 15.0 software. To compare the performance of
restorative materials according to FDI criteria over the study period, the Fisher's
Chi-Square test was used. The Cochran's Q test was then used to compare the 1-2-3 and 4-year
scores of each material with baseline scores to evaluate the changes of each dependent group
by the time. Survival curves were obtained using Kaplan-Meier method. p values less than
0.05 were considered to be statistically significant in all tests.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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