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Comparison of Two Universal Composites in Posterior Teeth

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT02888873
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
24
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Charisma
  • Other: Charisma Classic
 N/A

Detailed Description

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Charisma

applied randomly

Other: Charisma
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

    		•
    Active Comparator: Charisma classic

    applied randomly

    Other: Charisma Classic
    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

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University School of Dentistry Ankara Turkey 06100

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    • Study Director: Sevil Gurgan, DDS, PhD, Hacettepe University School of Dentistry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeynep Bilge Kutuk, Research Assistant, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT02888873
    Other Study ID Numbers:
    • 2014/03-13(KA-14005)
    First Posted:
    Sep 5, 2016
    Last Update Posted:
    Sep 5, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Zeynep Bilge Kutuk, Research Assistant, Hacettepe University
    composite resin
    Clinical trial
    FDI (World Dental Federation) criteria
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Sep 5, 2016