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

NCT02893735 | Completed DMC

• 1 other identifier: 2014/03-4(KA-14004)
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Diastema

Keywords

Clinical Trial; Composite resin

Outcome Measures

Primary Outcomes (1)

• Clinical performance of restorations, graded on a 5-point scale, using FDI criteria

  This outcome may be classified as "1-Clinically excellent/ very good", "2-Clinically good (after correction, very good)", "3-Clinically sufficient/ satisfactory (minor shortcomings with no adverse effects but not adjustable without damage to the tooth)", "4-Clinically unsatisfactory (repair for prophylactic reasons)", "5-Clinically poor (replacement necessary)" classification of the Esthetic, Functional and Biological properties

  Change from baseline to 4 year outcome of restorations were evaluated.

Secondary Outcomes (8)

• Surface Luster, graded on a 5-point scale (FDI criteria)

  Change from baseline to 4 year outcome of restorations were evaluated.

• Staining margin, graded on a 5-point scale (FDI criteria)

  Change from baseline to 4 year outcome of restorations were evaluated.

• Colour stability and translucency, graded on a 5-point scale (FDI criteria)

  Change from baseline to 4 year outcome of restorations were evaluated.

• Fractures and Retention, graded on a 5-point scale (FDI criteria)

  Change from baseline to 4 year outcome of restorations were evaluated.

• Marginal Adaptation, graded on a 5-point scale (FDI criteria)

  Change from baseline to 4 year outcome of restorations were evaluated.

Study Arms (2)

Charisma-Diamond

ACTIVE COMPARATOR

Charisma Diamond was randomly applied for diastema closure.

Other: Charisma-Diamond

Filtek-Z550

ACTIVE COMPARATOR

Filtek-Z550 was randomly applied for diastema closure.

Other: Filtek-Z550

Interventions

Charisma-Diamond 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.

Charisma-Diamond

Filtek-Z550 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.

Filtek-Z550

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University School of Dentistry

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Diastema

Interventions

Filtek Z550

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sevil Gurgan, PhD, DDS

  Hacettepe University School of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: September 8, 2016
• Study Start: December 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)