Comparison of Two Universal Composites in Posterior Teeth

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888873
• Other study ID #: 2014/03-13(KA-14005)
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: August 30, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University School of Dentistry	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Observers evaluated the biological properties of the restorations using FDI (World Dental Federation) Criteria.	"Recurrence of caries, erosion, abfraction"; and "Tooth integrity (enamel cracks, tooth fractures)"	The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.	Yes
Primary	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.	Yes
Secondary	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.	Yes