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Completed

NCT Number: NCT02888873

Comparison of Two Universal Composites in Posterior Teeth

The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University School of Dentistry

Ankara, 06100, Turkey (Türkiye)

About this study

A total of 80 (13 Class 1 and 67 Class 2) lesions in 40 patients (21 females, 19 males) with ages ranging between 18-38 years (23.15±5.15) were either restored with Charisma or Charisma Classic (Heraeus Kulzer) in combination with an etch and rinse adhesive system (Gluma 2 Bond) under rubber dam isolation by two experienced operators according to the manufacturer's instructions. Two independent examiners, who were blinded to the composites used evaluated the restorations according to the FDI (World Dental Federation) criteria. Bite-wing radiographs and intraoral digital photographs were taken before and after treatment and at 6 months. The statistical analyses were carried out with McNemar, Pearson Chi-square and Cochran Q tests (p<0.05).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a need for at least two but not more than four posterior tooth-colored restorations
  • the presence of teeth to be restored in occlusion
  • teeth that were symptomless and vital
  • a normal periodontal status
  • a good likelihood of recall availability.

Exclusion criteria

  • partly erupted teeth
  • absence of adjacent and antagonist teeth
  • poor periodontal status
  • adverse medical history
  • potential behavioral problems.

Treatment and study plan

Charisma

Other

The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.

Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.

Other names: universal composite

Charisma Classic

Other

The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma classic was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.

Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.

Other names: universal composite

Primary outcomes

  1. Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.

    Time frame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

    "Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"

Secondary outcomes

  1. Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.

    Time frame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

    "Fracture of material and retention"; "Marginal adaptation"

Other outcomes

  1. Observers evaluated the biological properties of the restorations using FDI (World Dental Federation) Criteria.

    Time frame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

    "Recurrence of caries, erosion, abfraction"; and "Tooth integrity (enamel cracks, tooth fractures)"

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2016
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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