Clinical Comparison of Two Resin Composites on Diastema Closure and Reshaping at Four Years

NCT ID: NCT02893735

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-08-31

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.

Conditions

Diastema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Charisma-Diamond

Charisma Diamond was randomly applied for diastema closure.

Group Type: ACTIVE_COMPARATOR

Charisma-Diamond

Intervention Type: OTHER

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.

Filtek-Z550

Filtek-Z550 was randomly applied for diastema closure.

Group Type: ACTIVE_COMPARATOR

Filtek-Z550

Intervention Type: OTHER

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.

Interventions

Charisma-Diamond

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.

Intervention Type: OTHER

Filtek-Z550

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Bilge Kutuk

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevil Gurgan, PhD, DDS

Role: STUDY_DIRECTOR

Hacettepe University School of Dentistry

Locations

Hacettepe University School of Dentistry

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: BACKGROUND

Other Identifiers

2014/03-4(KA-14004)

Identifier Type: -

Identifier Source: org_study_id