Clinical trial NCT02888912: Clinical Performance of a Glass-ionomer Restorative System: A 6-year Evaluation
Official title: Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: glass ionomer cement
composite resin
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 54
Sex: ALL
Minimum age (years): 15
Maximum age (years): 37
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in class I and class II cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct). Restorations were evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p\<0.05).

Detailed description: Since the introduction of glass ionomers many modifications of these materials have been performed over the years. Compared to other permanent filling materials like resin-based composites, glass ionomers show several advantages, such as the ability to adhere to moist enamel and dentin and anti-cariogenic properties such as the long-term fluoride release. So, it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based composites in posterior teeth.

Eligibility criteria: Inclusion Criteria:

1. a need for at least two but not more than four posterior toothcolored restorations;
2. the presence of teeth to be restored in occlusion;
3. teeth that were symptomless and vital;
4. a normal periodontal status;
5. a good likelihood of recall availability.

Exclusion Criteria:

1. partly erupted teeth;
2. absence of adjacent and antagonist teeth
3. poor periodontal status;
4. adverse medical history;
5. potential behavioral problems.

Primary outcomes:
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation.
timeFrame: From baseline to 6 year the change of restorations was evaluated
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.
timeFrame: From baseline to 6 year the change of restorations was evaluated
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate.
timeFrame: From baseline to 6 year the change of restorations was evaluated
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.
timeFrame: From baseline to 6 year the change of restorations was evaluated
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change.
timeFrame: From baseline to 6 year the change of restorations was evaluated
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University School of Dentistry
name: Sevil Gurgan, Phd, DDS
role: STUDY_DIRECTOR
References:
citation: Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system. Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. Epub 2014 Oct 9.