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

NCT ID: NCT04298151

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-10-01

Brief Summary

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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

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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

Conditions

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Geriatric Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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zirconomer improved

zirconia reinforced glass ionomer restoration

Group Type EXPERIMENTAL

Zirconomer Improved

Intervention Type DRUG

glass ionomer restoration reinforced with nano-zirconia particles to improve strength and esthetics

ketac molar quick aplicap

conventional viscous glass ionomer restoration

Group Type ACTIVE_COMPARATOR

Ketac Molar quick Aplicap

Intervention Type DRUG

highly viscous glass ionomer with improved mechanical properties than the conventional GI

Interventions

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Zirconomer Improved

glass ionomer restoration reinforced with nano-zirconia particles to improve strength and esthetics

Intervention Type DRUG

Ketac Molar quick Aplicap

highly viscous glass ionomer with improved mechanical properties than the conventional GI

Intervention Type DRUG

Other Intervention Names

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zirconia reinforced GI KMQ aplicap

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Mohammed Mohammed Abdou

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Doaa Abdou

Giza, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 27156000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27461814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30034008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29663908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21840585 (View on PubMed)

Other Identifiers

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Zirconia GI Conventional GI

Identifier Type: -

Identifier Source: org_study_id

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