Dental Caries in ChildrenZirconomerNCT06254053
Clinical and Radiographic Evaluation of Zirconomer Restorative
A study testing zirconia reinforced glass ionomer and Glass ionomer cement in people with Dental Caries in Children and Dental Materials, run by Cairo University at 1 site in Egypt.
Trial summary
Is zirconomer restorative material more effective than a glass ionomer cement in restoration of primary molars Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Dental Caries in Children, Dental Materials
- What is being tested?
- zirconia reinforced glass ionomer and Glass ionomer cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- <!-- -->
- Patients with systemic diseases.
- Parent refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Zirconomer Restorative Material Versus a Glass Ionomer Cement in Restoration of Primary Molars A Randomized Clinical Trial
Is zirconomer restorative material more effective than a glass ionomer cement in restoration of primary molars
Read the detailed description
This trial seeks to evaluate the clinical and radiographic performance of two materials zirconomer restorative material and glass ionomer cement to achieve better treatment for primary molars.
- Conditions
- Dental Caries in Children, Dental Materials
- Being tested
- zirconia reinforced glass ionomer, Glass ionomer cement
- Keywords
- GIc/Zirconomer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zirconia reinforced glass ionomerOther
Also called zirconomer
Restorative material
Glass ionomer cementOther
Also called GIC
Restorative material
| Study group | Role | What they receive |
|---|---|---|
| Zirconomer Restorative material in primary molar | Experimental | Arm one zirconomer restorative material (intervention) Receives: Other: zirconia reinforced glass ionomer |
| Glass Ionomer Cement in primary molar | Active comparator | Arm two Glass Ionomer cement (control) Receives: Other: Glass ionomer cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent CariesColor match
Radiographic Visual inspection using Modified United States Public Health Service Ryge criteria USPHS
Measured: 12 MONTHS
Secondary outcomes (4)
Color match
visual inspection using Modified United States Public Health Service Ryge criteria USPHS
Measured: 12 MONTHS
Marginal Discoloration
using visual inspection Modified United States Public Health Service Ryge criteria USPHS
Measured: 12 MONTHS
Marginal Adaptation
using visual inspection Modified United States Public Health Service Ryge criteria USPHS
Measured: 12 MONTHS
-Anatomic Form
using visual inspection Modified United States Public Health Service Ryge criteria USPHS
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Apr 2025
- Primary completion1 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamador Ahmed Ibrahim, Cairo University
- Investigators
- sherien ez zaldein, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254053
- Sponsor's protocol ID
- Evaluation of zirconomer
- Other IDs
- cairo university
- Acronym
- Zirconomer
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol and statistical analysis
Publications
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.
PubMed 34904122Kukreja 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.
PubMed 35528493undefined
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.
PubMed 34393122Arora 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.
PubMed 35439879Albeshti 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.
PubMed 30034008
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Zirconomer Restorative Material Versus a Glass Ionomer Cement in Restoration of Primary Molars A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06254053
- Acronym / sponsor ID
- Zirconomer / Evaluation of zirconomer
- Conditions
- Dental Caries in Children, Dental Materials
- Keywords
- GIc/Zirconomer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Is zirconomer restorative material more effective than a glass ionomer cement in restoration of primary molars
Detailed description
This trial seeks to evaluate the clinical and radiographic performance of two materials zirconomer restorative material and glass ionomer cement to achieve better treatment for primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Zirconomer Restorative material in primary molar | Experimental | Other: zirconia reinforced glass ionomerArm one zirconomer restorative material (intervention) |
| Glass Ionomer Cement in primary molar | Active comparator | Other: Glass ionomer cementArm two Glass Ionomer cement (control) |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
Key exclusion criteria (3 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zirconia reinforced glass ionomerAlso: zirconomerRestorative material | Other | Zirconomer Restorative material in primary molar |
| Glass ionomer cementAlso: GICRestorative material | Other | Glass Ionomer Cement in primary molar |
Primary outcome
Recurrent CariesColor match
Time frame: 12 MONTHS
Radiographic Visual inspection using Modified United States Public Health Service Ryge criteria USPHS
4 secondary outcomes
Color match
Time frame: 12 MONTHS
Marginal Discoloration
Time frame: 12 MONTHS
Marginal Adaptation
Time frame: 12 MONTHS
-Anatomic Form
Time frame: 12 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 34904122Nanavati 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.
- Background: PubMed 35528493Kukreja 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.
- Backgroundundefined
- Background: PubMed 34393122Mushtaq 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.
- Background: PubMed 35439879Arora 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.
- Background: PubMed 30034008Albeshti 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.
- Individual participant dataSharing planned: Yes. study protocol and statistical analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sherien ez zaldein, professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zirconia reinforced glass ionomer and Glass ionomer cement in people with Dental Caries in Children and Dental Materials, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent CariesColor match (time frame: 12 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06254053, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.