Clinical Comparison of Two Resin Composites on Diastema Closure and Reshaping at Four Years
Condition: Diastema
MeSH terms: Diastema
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Charisma-Diamond; Filtek-Z550
Intervention type(s): Other; Other
Intervention description(s): The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Nano-hybrid resin composite system was used Charisma-Diamond in combination Gluma2 Bond etch&rinse adhesive. The composite increments were carefully placed between the matrix strip and tooth by using a hand instrument. The composite resin restorations were light-cured (600 mW/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups whereas; proximal and labial surfaces were contoured and polished with finishing strips. The treatments were completed by instructing the patients about the oral hygiene measures for cleaning their restorations with toothbrush and dental floss.; The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Nano-hybrid resin composite system was used Filtek-Z550 in combination with Adper™ Single Bond 2 etch&rinse adhesive. The composite increments were carefully placed between the matrix strip and tooth by using a hand instrument. The composite resin restorations were light-cured (600 mW/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups whereas; proximal and labial surfaces were contoured and polished with finishing strips. The treatments were completed by instructing the patients about the oral hygiene measures for cleaning their restorations with toothbrush and dental floss.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Clinical Trial; Composite resin