GeriatricPhase 2NCT04298151
Clinical Performance of Zirconia Reinforced GI Versus Conventional Viscous GI in Geriatric Patients
A Phase 2 study testing Zirconomer Improved and Ketac Molar quick Aplicap in people with Geriatric and Performance, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Geriatric, Performance
- What is being tested?
- Zirconomer Improved and Ketac Molar quick Aplicap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Oct 2022
- Phase
- Phase 2
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Zirconia Reinforced Versus Conventional Viscous Glass Ionomer in Posterior Restorations of Geriatric Patients: Randomized Controlled Trial
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
Read the detailed 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
- Conditions
- Geriatric, Performance
- Being tested
- Zirconomer Improved, Ketac Molar quick Aplicap
- Keywords
- Glass ionomer, Restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconomer ImprovedDrug
Also called zirconia reinforced GI
glass ionomer restoration reinforced with nano-zirconia particles to improve strength and esthetics
Ketac Molar quick AplicapDrug
Also called KMQ aplicap
highly viscous glass ionomer with improved mechanical properties than the conventional GI
| Study group | Role | What they receive |
|---|---|---|
| zirconomer improved | Experimental | zirconia reinforced glass ionomer restoration Receives: Drug: Zirconomer Improved |
| ketac molar quick aplicap | Active comparator | conventional viscous glass ionomer restoration Receives: Drug: Ketac Molar quick Aplicap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
clinical performance of the Glass Ionomer restorations using modified USPHS criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GeriatricStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mohammed Mohammed Abdou, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298151
- Sponsor's protocol ID
- Zirconia GI Conventional GI
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27156000Walia 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.
PubMed 27461814Albeshti 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 30034008de 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.
PubMed 29663908Friedl 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.
PubMed 21840585
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Zirconia Reinforced Versus Conventional Viscous Glass Ionomer in Posterior Restorations of Geriatric Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04298151
- Acronym / sponsor ID
- Zirconia GI Conventional GI
- Conditions
- Geriatric, Performance
- Keywords
- Glass ionomer, Restorations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 6 Mar 2020 (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.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zirconomer improved | Experimental | Drug: Zirconomer Improvedzirconia reinforced glass ionomer restoration |
| ketac molar quick aplicap | Active comparator | Drug: Ketac Molar quick Aplicapconventional viscous glass ionomer restoration |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Zirconomer ImprovedAlso: zirconia reinforced GIglass ionomer restoration reinforced with nano-zirconia particles to improve strength and esthetics | Drug | zirconomer improved |
| Ketac Molar quick AplicapAlso: KMQ aplicaphighly viscous glass ionomer with improved mechanical properties than the conventional GI | Drug | ketac molar quick aplicap |
Primary outcome
Clinical performance
Time frame: 1 year
clinical performance of the Glass Ionomer restorations using modified USPHS criteria
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 6 Feb 2024.
- Background: PubMed 27156000Klinke 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.
- Background: PubMed 27461814Walia 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.
- 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.
- Background: PubMed 29663908de 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.
- Background: PubMed 21840585Friedl 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zirconomer Improved and Ketac Molar quick Aplicap in people with Geriatric and Performance, 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 5 inclusion and 6 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 6 Feb 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical performance (time frame: 1 year). 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 NCT04298151, which also lists 5 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 6 Feb 2024.