Dental Caries
Conditions
Keywords
composite resin, Clinical trial, FDI (World Dental Federation) criteria
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).
Interventions
OTHERCharisma
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.
OTHERCharisma 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.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 38 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Turkey (Türkiye)
Outcome results
None listed