Clinical Performance of Zirconia Reinforced GI Versus Conventional Viscous GI in Geriatric Patients

Performance Clinical Trial

Official title:

Clinical Evaluation of Zirconia Reinforced Versus Conventional Viscous Glass Ionomer in Posterior Restorations of Geriatric Patients: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298151
• Other study ID #: Zirconia GI Conventional GI
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Geriatric
• Performance

Intervention

Drug:
• Zirconomer Improved
glass ionomer restoration reinforced with nano-zirconia particles to improve strength and esthetics
• Ketac Molar quick Aplicap
highly viscous glass ionomer with improved mechanical properties than the conventional GI

Locations

Country	Name	City	State
Egypt	Doaa Abdou	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance	clinical performance of the Glass Ionomer restorations using modified USPHS criteria	1 year