Dental Caries in ChildrenNCT07152561
Different Luting Cements for Pediatric Zirconia Crowns
A study testing Zirconia crown cemented with Predicta® Bioactive Cement and Zirconia crown cemented with resin-cement in people with Dental Caries in Children, run by Cairo University.
Trial summary
The study aims to compare the efficacy of using bioactive cement versus resin-cement for cementation of anterior pediatric zirconia crowns. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Zirconia crown cemented with Predicta® Bioactive Cement and Zirconia crown cemented with resin-cement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who had no history of allergies
- Children who had at least two carious primary incisors.
- Teeth with multi-surface carious lesion.
- Teeth with no percussion or palpation sensitivity
- Teeth with no abscess and/or fistula
- Teeth with no prior pulpal treatment
- Teeth with no mobility or signs of periodontal disease
Who cannot join
- Children with congenital developmental defects (such as amelogenesis imperfecta and dentinogenesis imperfecta)
- Children with a history of bruxism, trauma or infraocclusion
- Children with a skeletal or dental malocclusion
About this study
Official title: Effect of Two Different Luting Cements on Clinical Outcomes of Pediatric Zirconia Crowns: A Randomized Controlled Trial
The study aims to compare the efficacy of using bioactive cement versus resin-cement for cementation of anterior pediatric zirconia crowns.
Read the detailed description
- For the bioactive cement group (Predicta® Bioactive Cement), the prepared tooth will be dried using compressed air but not desiccated. Cement will be dispensed through the auto-mixtip directly into the crown, and the crown will be properly positioned over the tooth; cement will be allowed to self-set for 20 seconds while maintaining gentle pressure on the crown. Buccal and lingual margins will be flash-cured for 10 seconds each using a light-curing unit to immediately cure the excess cement for easier removal, and buccal and lingual surfaces will then be light-cured for an extra 10 seconds each.
- For the resin-cement group, the tooth will be dried with compressed air but not desiccated. The sealant will be applied with the syringe; then, the crown will be appropriately positioned over the tooth, and cement will be allowed to self-set for 2 minutes and cured while maintaining gentle pressure on the crown. Excess cement will be removed before the cement is completely set.
- Conditions
- Dental Caries in Children
- Being tested
- Zirconia crown cemented with Predicta® Bioactive Cement, Zirconia crown cemented with resin-cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia crown cemented with Predicta® Bioactive CementDrug
- For the bioactive cement group (Predicta® Bioactive Cement), the prepared tooth will be dried using compressed air but not desiccated. Cement will be dispensed through the auto-mixtip directly into the crown, and the crown will be properly positioned over the tooth; cement will be allowed to self-set for 20 seconds while maintaining gentle pressure on the crown. Buccal and lingual margins will be flash-cured for 10 seconds each using a light-curing unit to immediately cure the excess cement for easier removal, and buccal and lingual surfaces will then be light-cured for an extra 10 seconds each.
Zirconia crown cemented with resin-cementDrug
- For the resin-cement group, the tooth will be dried with compressed air but not desiccated. The sealant will be applied with the syringe; then, the crown will be appropriately positioned over the tooth, and cement will be allowed to self-set for 2 minutes and cured while maintaining gentle pressure on the crown. Excess cement will be removed before the cement is completely set.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Zirconia crown cemented with Predicta® Bioactive Cement Receives: Drug: Zirconia crown cemented with Predicta® Bioactive Cement |
| Arm 2 | Active comparator | Zirconia crown cemented with resin-cement Receives: Drug: Zirconia crown cemented with resin-cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Retention will be assessed by visual inspection and probe to detect debonded crowns.
Measured: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months
Fracture
Fractures will be assessed using visual inspection to detect incomplete fracture lines or complete fractures with loss of crown material.
Measured: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months
Secondary outcomes (1)
The gingival condition
The gingival condition around cemented crowns will be assessed by calculating the gingival index for each crowned tooth.
Measured: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start28 Aug 2025 (estimated)
- Primary completion28 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Mohamed Hatem Hanafy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152561
- Sponsor's protocol ID
- Pediatric Zirconia Crowns
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Luting Cements on Clinical Outcomes of Pediatric Zirconia Crowns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07152561
- Acronym / sponsor ID
- Pediatric Zirconia Crowns
- Conditions
- Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Aug 2025 (estimated)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Sep 2025 (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.
The study aims to compare the efficacy of using bioactive cement versus resin-cement for cementation of anterior pediatric zirconia crowns.
Detailed description
- For the bioactive cement group (Predicta® Bioactive Cement), the prepared tooth will be dried using compressed air but not desiccated. Cement will be dispensed through the auto-mixtip directly into the crown, and the crown will be properly positioned over the tooth; cement will be allowed to self-set for 20 seconds while maintaining gentle pressure on the crown. Buccal and lingual margins will be flash-cured for 10 seconds each using a light-curing unit to immediately cure the excess cement for easier removal, and buccal and lingual surfaces will then be light-cured for an extra 10 seconds each.
- For the resin-cement group, the tooth will be dried with compressed air but not desiccated. The sealant will be applied with the syringe; then, the crown will be appropriately positioned over the tooth, and cement will be allowed to self-set for 2 minutes and cured while maintaining gentle pressure on the crown. Excess cement will be removed before the cement is completely set.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Zirconia crown cemented with Predicta® Bioactive CementZirconia crown cemented with Predicta® Bioactive Cement |
| Arm 2 | Active comparator | Drug: Zirconia crown cemented with resin-cementZirconia crown cemented with resin-cement |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients who had no history of allergies
- Children who had at least two carious primary incisors.
- Teeth with multi-surface carious lesion.
- Teeth with no percussion or palpation sensitivity
- Teeth with no abscess and/or fistula
Key exclusion criteria (3 listed)
- Children with congenital developmental defects (such as amelogenesis imperfecta and dentinogenesis imperfecta)
- Children with a history of bruxism, trauma or infraocclusion
- Children with a skeletal or dental malocclusion
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 crown cemented with Predicta® Bioactive Cement• For the bioactive cement group (Predicta® Bioactive Cement), the prepared tooth will be dried using compressed air but not desiccated. Cement will be dispensed through the auto-mixtip directly into the crown, and the crown will be properly positioned over the tooth; cement will be allowed to self-set for 20 seconds while maintaining gentle pressure on the crown. Buccal and lingual margins will be flash-cured for 10 seconds each using a light-curing unit to immediately cure the excess cement for easier removal, and buccal and lingual surfaces will then be light-cured for an extra 10 seconds each. | Drug | Arm 1 |
| Zirconia crown cemented with resin-cement• For the resin-cement group, the tooth will be dried with compressed air but not desiccated. The sealant will be applied with the syringe; then, the crown will be appropriately positioned over the tooth, and cement will be allowed to self-set for 2 minutes and cured while maintaining gentle pressure on the crown. Excess cement will be removed before the cement is completely set. | Drug | Arm 2 |
Primary outcome
Retention
Time frame: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months
Retention will be assessed by visual inspection and probe to detect debonded crowns.
Fracture
Time frame: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months
Fractures will be assessed using visual inspection to detect incomplete fracture lines or complete fractures with loss of crown material.
1 secondary outcome
The gingival condition
Time frame: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia crown cemented with Predicta® Bioactive Cement and Zirconia crown cemented with resin-cement in people with Dental Caries in Children, run by Cairo University.
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 7 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: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Retention (time frame: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2025.