Clinical and Radiographic Evaluation of Zirconomer Restorative

NCT06254053 | Not Yet Recruiting DMC

• 2 other identifiers: Evaluation of zirconomercairo university
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Is zirconomer restorative material more effective than a glass ionomer cement in restoration of primary molars

Conditions

Dental Caries in Children; Dental Materials

Keywords

GIc/Zirconomer

Outcome Measures

Primary Outcomes (1)

• Recurrent CariesColor match

  Radiographic Visual inspection using Modified United States Public Health Service Ryge criteria USPHS

  12 MONTHS

Secondary Outcomes (4)

• Color match

  12 MONTHS

• Marginal Discoloration

  12 MONTHS

• Marginal Adaptation

  12 MONTHS

• -Anatomic Form

  12 MONTHS

Study Arms (2)

Zirconomer Restorative material in primary molar

EXPERIMENTAL

Arm one zirconomer restorative material (intervention)

Other: zirconia reinforced glass ionomer

Glass Ionomer Cement in primary molar

ACTIVE COMPARATOR

Arm two Glass Ionomer cement (control)

Other: Glass ionomer cement

Interventions

zirconia reinforced glass ionomer OTHER

Restorative material

Also known as: zirconomer

Zirconomer Restorative material in primary molar

Glass ionomer cement OTHER

Restorative material

Also known as: GIC

Glass Ionomer Cement in primary molar

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children having carious primary molars(class1) without pulp exposure and normal radiograph.
• Children between age 5 and 7 years.
• Both male and female are included.
• Cooperative Children.

You may not qualify if:

• <!-- -->
• Patients with systemic diseases.
• Parent refuse to participate.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (6)

• Nanavati K, Katge F, Chimata VK, Pradhan D, Kamble A, Patil D. Comparative Evaluation of Shear Bond Strength of Bioactive Restorative Material, Zirconia Reinforced Glass Ionomer Cement and Conventional Glass Ionomer Cement to the Dentinal Surface of Primary Molars: an in vitro Study. J Dent (Shiraz). 2021 Dec;22(4):260-266. doi: 10.30476/DENTJODS.2021.87115.1230.

  PMID: 34904122 BACKGROUND

• Kukreja R, Singla S, Bhadoria N, Pawar P, Gupta K, Khandelwal D, Dewani N. An In Vitro Study to Compare the Release of Fluoride from Glass Ionomer Cement (Fuji IX) and Zirconomer. Int J Clin Pediatr Dent. 2022 Jan-Feb;15(1):35-37. doi: 10.5005/jp-journals-10005-2141.

  PMID: 35528493 BACKGROUND

• undefined

  BACKGROUND

• Mushtaq U, Mushtaq F, Thakur D, Rathee K, Poonia N, Khullar S. Comparative Evaluation of Postoperative Sensitivity Following Restoration of Class I Lesions with Different Restorative Materials: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):650-654.

  PMID: 34393122 BACKGROUND

• Arora D, Jain M, Suma Sogi HP, Shahi P, Gupta I, Sandhu M. In vivo evaluation of clinical performance of Cention N and glass ionomer cement in proximal restorations of primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):23-29. doi: 10.4103/jisppd.jisppd_108_21.

  PMID: 35439879 BACKGROUND

• 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: 30034008 BACKGROUND

MeSH Terms

Interventions

Glass Ionomer Cements

Intervention Hierarchy (Ancestors)

Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• sherien ez zaldein, professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Tamador A hmedIbrahim ali, Master

CONTACT

347-933-7140; tamadurah699@gamil.com

Mujahed a hmed Ibrahim Ali, MASTER

CONTACT

749-404-6041; Mugahed.ali95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR tamador ahmed

Model Details: last decade has seen several innovative additions to enhance the properties of GIC whilst simplifying its usage. Unlike the early glass-ionomers, these newer systems are easy and more practical to use as a dental restorative and luting material for preschoolers, children and teenagers alike. These new varieties are composed of ceramic and zirconia reinforced glass ionomer cements were introduced to provide better drawbacks of amalgam as well as tooth-colored restorative materials exhibiting the strength of amalgam and at the same time maintain the fluoride releasing capacity of GIC providing better mechanical properties.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 12, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 3, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after one year
• Access Criteria: with other investigator including who will work with systematic review ,will provide the clinical study report with the documents above