NCT04298151

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

March 4, 2020

Last Update Submit

February 5, 2024

Conditions

GeriatricPerformance

Keywords

Glass ionomerRestorations

Outcome Measures

Primary Outcomes (1)

  • Clinical performance

    clinical performance of the Glass Ionomer restorations using modified USPHS criteria

    1 year

Study Arms (2)

zirconomer improved

EXPERIMENTAL

zirconia reinforced glass ionomer restoration

Drug: Zirconomer Improved

ketac molar quick aplicap

ACTIVE COMPARATOR

conventional viscous glass ionomer restoration

Drug: Ketac Molar quick Aplicap

Interventions

Zirconomer ImprovedDRUG

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

Also known as: zirconia reinforced GI
zirconomer improved
Ketac Molar quick AplicapDRUG

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

Also known as: KMQ aplicap
ketac molar quick aplicap

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doaa Abdou

Giza, 12573, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 27156000BACKGROUND

  • 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.

    PMID: 27461814BACKGROUND

  • 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.

    PMID: 30034008BACKGROUND

  • 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.

    PMID: 29663908BACKGROUND

  • 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.

    PMID: 21840585BACKGROUND

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)