Clinical trial NCT04298151: Clinical Performance of Zirconia Reinforced GI Versus Conventional Viscous GI in Geriatric Patients
Official title: Clinical Evaluation of Zirconia Reinforced Versus Conventional Viscous Glass Ionomer in Posterior Restorations of Geriatric Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Geriatric
Performance
Keywords: Glass ionomer
Restorations
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted to evaluate the clinical performance of Zirconomer Improved GI restoration compared to Conventional viscous GI restoration in geriatric patients with Posterior carious lesions in class I or II cavities

Detailed description: This study will be conducted to determine the clinical performance of the Zirconia reinforced glass ionomer restorations ( Zirconomer improved) under stress bearing posterior area (class I or claa II cavities) in geriatric population in comparison to Conventional viscous glass ionomer restorations (Ketac molar quick Aplicap) using the modified United States Public Health Service (USPHS) criteria

P: Geriatric Patients with posterior Caries lesions I: Zirconia reinforced GI (Zirconomer Improved) C: Conventional viscous GI, (Ketac Molar quick Aplicap) O: The Clinical performance of the Glass Ionomer restorations Using USPHS Criteria

Eligibility criteria: Inclusion Criteria:

* Age range 60-80 years
* Geriatric patients with Class I or II Posterior carious lesions.
* Males or Females.
* Pulp asymptomatic vital carious posterior teeth.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Age range less than 60 years.
* Disabilities.
* Deep extensive carious cavities that may lead to fracture of the tooth or pulpal affection.
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
* Heavy smoking.
* Lack of compliance.

Primary outcomes:
measure: Clinical performance
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Doaa Abdou
Study officials:
References:
citation: Klinke T, Daboul A, Turek A, Frankenberger R, Hickel R, Biffar R. Clinical performance during 48 months of two current glass ionomer restorative systems with coatings: a randomized clinical trial in the field. Trials. 2016 May 8;17(1):239. doi: 10.1186/s13063-016-1339-8.
citation: Walia R, Jasuja P, Verma KG, Juneja S, Mathur A, Ahuja L. A comparative evaluation of microleakage and compressive strength of Ketac Molar, Giomer, Zirconomer, and Ceram-x: An in vitro study. J Indian Soc Pedod Prev Dent. 2016 Jul-Sep;34(3):280-4. doi: 10.4103/0970-4388.186746.
citation: Albeshti R, Shahid S. Evaluation of Microleakage in Zirconomer(R): A Zirconia Reinforced Glass Ionomer Cement. Acta Stomatol Croat. 2018 Jun;52(2):97-104. doi: 10.15644/asc52/2/2.
citation: de Franca Lopes CMC, Schubert EW, Martins AS, Loguercio AD, Reis A, Chibinski ACR, Wambier DS. Randomized Clinical Trial of ART Class II Restorations Using Two Glass Ionomer Cements: One-Year Follow-Up. Pediatr Dent. 2018 Mar 15;40(2):98-104.
citation: Friedl K, Hiller KA, Friedl KH. Clinical performance of a new glass ionomer based restoration system: a retrospective cohort study. Dent Mater. 2011 Oct;27(10):1031-7. doi: 10.1016/j.dental.2011.07.004. Epub 2011 Aug 15.