Comparison of Two Universal Composites in Posterior Teeth

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Other: Charisma Classic; Other: Charisma

• Registration Number: NCT02888873
• Lead Sponsor: Hacettepe University

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).

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-08
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-30
• Last Update Submitted: 2016-08-30
• Study First Posted: 2016-09-05
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Charisma classic	Charisma Classic	applied randomly
Charisma	Charisma	applied randomly

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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"

Trial Locations

Locations (1)

Hacettepe University School of Dentistry; 🇹🇷 Ankara, Turkey