Comparison of Two Universal Composites in Posterior Teeth

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Charisma
* Other: Charisma Classic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Charisma<br>applied randomly | Other: Charisma<br>* 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.<br>* Other names: universal composite;|
| Active Comparator: Charisma classic<br>applied randomly | Other: Charisma Classic<br>* 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.<br>* Other names: universal composite;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria. | Fracture of material and retention; Marginal adaptation | The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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composite resin, Clinical trial, FDI (World Dental Federation) criteria