Clinical trial NCT03822403: Clinical Performance Evaluation of a Glass-ionomer Restorative System Evaluation
Official title: Randomized, Controlled Clinical Evaluation of Glass Ionomer System vs Composite Posterior Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: glass ionomer
composite resin
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: 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 9 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 Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Marginal adaptation
timeFrame: From baseline to 9 year the change of restorations was evaluated
measure: marginal discoloration
timeFrame: From baseline to 9 year the change of restorations was evaluated
measure: retention rate
timeFrame: From baseline to 9 year the change of restorations was evaluated
measure: anatomic form
timeFrame: From baseline to 9 year the change of restorations was evaluated
measure: color change
timeFrame: From baseline to 9 year the change of restorations was evaluated
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University School of Dentistry
Study officials:
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.
citation: Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Clinical performance of a glass ionomer restorative system: a 6-year evaluation. Clin Oral Investig. 2017 Sep;21(7):2335-2343. doi: 10.1007/s00784-016-2028-4. Epub 2016 Dec 20.
citation: Turkun LS, Kanik O. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis? Oper Dent. 2016 Nov/Dec;41(6):587-598. doi: 10.2341/15-331-C. Epub 2016 Aug 29.