Clinical trial NCT02893735: Clinical Comparison of Two Resin Composites on Diastema Closure and Reshaping at Four Years
Official title: A Prospective 4-year Clinical Study Evaluating Two Resin Composites on Diastema Closure and Reshaping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastema
Keywords: Clinical Trial
Composite resin
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* all subjects were required to be at least 18 years old,
* able to read and sign the informed consent document,
* physically and psychologically able to tolerate conventional restorative procedures,
* having no active periodontal or pulpal diseases,
* having teeth with good restorations, and
* willing to return for follow-up examinations as outlined by the investigators.

Exclusion Criteria:

* uncontrolled parafunction;
* insufficient oral hygiene leading to caries lesions more than twice yearly during the previous 2 years;
* being pregnant or nursing; and
* having periodontal or gingival disease.

Primary outcomes:
measure: Clinical performance of restorations, graded on a 5-point scale, using FDI criteria
timeFrame: Change from baseline to 4 year outcome of restorations were evaluated.
Secondary outcomes:
measure: Surface Luster, graded on a 5-point scale (FDI criteria)
timeFrame: Change from baseline to 4 year outcome of restorations were evaluated.
measure: Staining margin, graded on a 5-point scale (FDI criteria)
timeFrame: Change from baseline to 4 year outcome of restorations were evaluated.
measure: Colour stability and translucency, graded on a 5-point scale (FDI criteria)
timeFrame: Change from baseline to 4 year outcome of restorations were evaluated.
measure: Fractures and Retention, graded on a 5-point scale (FDI criteria)
timeFrame: Change from baseline to 4 year outcome of restorations were evaluated.
measure: Marginal Adaptation, graded on a 5-point scale (FDI criteria)
timeFrame: Change from baseline to 4 year outcome of restorations were evaluated.
measure: Postoperative Hypersensibility, tooth vitality, graded on a 5-point scale (FDI criteria)
timeFrame: Change from baseline to 4 year outcome of restorations were evaluated.
measure: Recurrence of Caries, erosion, abfraction, graded on a 5-point scale (FDI criteria)
timeFrame: Change from baseline to 4 year outcome of restorations were evaluated.
measure: Tooth integrity (enamel cracks), graded on a 5-point scale (FDI criteria)
timeFrame: Change from baseline to 4 year outcome of restorations were evaluated.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University School of Dentistry
Study officials:
affiliation: Hacettepe University School of Dentistry
name: Sevil Gurgan, PhD, DDS
role: STUDY_DIRECTOR
References:
citation: Ergin E, Kutuk ZB, Oztas SS, Cakir FY, Gurgan S. 6-Months Clinical Comparison of Two Resin Composites on Diastema Closure. J Dent Res (Spec Iss 94 A): 599, 2015