Clinical trial NCT02888873: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: composite resin
Clinical trial
FDI (World Dental Federation) criteria
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
timeFrame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
Secondary outcomes:
measure: Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.
timeFrame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
Other outcomes:
measure: Observers evaluated the biological properties of the restorations using FDI (World Dental Federation) Criteria.
timeFrame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University School of Dentistry
Study officials:
affiliation: Hacettepe University School of Dentistry
name: Sevil Gurgan, DDS, PhD
role: STUDY_DIRECTOR
References:
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
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.