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Comparison of Two Universal Composites in Posterior Teeth

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Charisma
Charisma Classic
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring composite resin, Clinical trial, FDI (World Dental Federation) criteria

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hacettepe University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Charisma

Charisma classic

Arm Description

applied randomly

applied randomly

Outcomes

Primary Outcome Measures

Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
"Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"

Secondary Outcome Measures

Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.
"Fracture of material and retention"; "Marginal adaptation"

Full Information

First Posted
August 24, 2016
Last Updated
August 30, 2016
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT02888873
Brief Title
Comparison of Two Universal Composites in Posterior Teeth
Official Title
Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
composite resin, Clinical trial, FDI (World Dental Federation) criteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Charisma
Arm Type
Active Comparator
Arm Description
applied randomly
Arm Title
Charisma classic
Arm Type
Active Comparator
Arm Description
applied randomly
Intervention Type
Other
Intervention Name(s)
Charisma
Other Intervention Name(s)
universal composite
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Charisma Classic
Other Intervention Name(s)
universal composite
Intervention Description
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.
Primary Outcome Measure Information:
Title
Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
Description
"Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"
Time Frame
The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
Secondary Outcome Measure Information:
Title
Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.
Description
"Fracture of material and retention"; "Marginal adaptation"
Time Frame
The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
Other Pre-specified Outcome Measures:
Title
Observers evaluated the biological properties of the restorations using FDI (World Dental Federation) Criteria.
Description
"Recurrence of caries, erosion, abfraction"; and "Tooth integrity (enamel cracks, tooth fractures)"
Time Frame
The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevil Gurgan, DDS, PhD
Organizational Affiliation
Hacettepe University School of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University School of Dentistry
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
Citation
Gurgan S, Vural UK, Kutuk ZB, Cakir FY. Comparison of two universal composites in posterior teeth: preliminary report. J Dent Res (Spec Iss 94 B): 308, 2015
Results Reference
result
PubMed Identifier
32748072
Citation
Gurgan S, Koc Vural U, Kutuk ZB, Cakir FY. Does a new formula have an input in the clinical success of posterior composite restorations? A chat study. Clin Oral Investig. 2021 Apr;25(4):1715-1727. doi: 10.1007/s00784-020-03472-5. Epub 2020 Aug 3.
Results Reference
derived

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Comparison of Two Universal Composites in Posterior Teeth

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