Dental CariesNCT07504393
Clinical Performance of Four Restorative Materials in Primary Molars
A study testing Cention N, Stela, SDI, Australia and Beautifil II, Shofu, Japan in people with Dental Caries and Primary Molars, run by Al-Azhar University.
Trial summary
This randomized clinical trial aims to compare the clinical and radiographic performance of four direct restorative materials used for restoring carious primary molars in children. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Dental Caries, Primary Molars
- What is being tested?
- Cention N, Stela, SDI, Australia and Beautifil II, Shofu, Japan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to Nov 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4-8 years old.
- Primary molars indicated for restorative treatment.
- No pulp involvement or history of dental pain.
- Cooperative children (Frankl: +ve or ++ve).
Who cannot join
- Pulp exposure after caries removal or clinical signs of irreversible pulpitis/necrosis.
- Severe developmental enamel defects or insufficient enamel for bonding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of an Alkasite Restoration Material (Cention N) and Self-cure Composite (Stela; SDI) Compared to Conventional Composite and Resin-modified Glass Ionomer in Primary Molars: A Randomized Clinical Trial
This randomized clinical trial aims to compare the clinical and radiographic performance of four direct restorative materials used for restoring carious primary molars in children. Eligible children aged 4-8 years with posterior primary molars requiring direct restoration will be randomly allocated (1:1:1:1) to receive one of the following materials: an alkasite restorative material (Cention N), a self-cure bulk-fill resin composite (Stela; SDI), a conventional light-cured nanohybrid resin composite (Beautifil II), or a resin-modified glass ionomer cement (Riva Light Cure). Restorations will be evaluated using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria. Postoperative sensitivity will be assessed at 48 hours using a 0-10 visual analogue scale (VAS). Clinical and radiographic follow-up assessments will be conducted at baseline and at scheduled recall visits
- Conditions
- Dental Caries, Primary Molars
- Being tested
- Cention N, Stela, SDI, Australia, Beautifil II, Shofu, Japan, Resin modified glass ionomer cement
- Keywords
- stela, Primary molars, Pediatric dentistry, Direct restoration, Cention N, Nanohybrid composite, Resin-modified glass ionomer, FDI criteria
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cention NDevice
Also called Ivoclar Vivadent
Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Stela, SDI, AustraliaDevice
Self-cure bulk-fill resin composite (Stela; SDI) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Beautifil II, Shofu, JapanDevice
Light-cured nanohybrid resin composite (Beautifil II) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Resin modified glass ionomer cementDevice
Resin-modified glass ionomer cement (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cention N | Experimental | Not described Receives: Device: Cention N |
| Group B: Stela (Self-cure Bulk-fill Composite) | Experimental | Not described Receives: Device: Stela, SDI, Australia |
| Group C: Beautifil II (Nanohybrid Composite) | Active comparator | Not described Receives: Device: Beautifil II, Shofu, Japan |
| Group D: Riva Light Cure (RMGIC) | Active comparator | Not described Receives: Device: Resin modified glass ionomer cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration success based on FDI criteria (clinical and radiographic evaluation)
Measured: 6 months
Restoration success based on FDI criteria (clinical and radiographic evaluation)
Clinical and radiographic success of restorations assessed using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria (scores 1-5). Scores 1-3 are considered clinically acceptable; scores 4-5 are considered clinically unacceptable (repair or replacement indicated).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Four-arm, parallel-group randomized clinical trial (1:1:1:1).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Hassan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504393
- Sponsor's protocol ID
- AAU-PEDO-1394-5575
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared to protect participant privacy and confidentiality, in accordance with the informed consent provided by the participants and the ethical approval granted for this study
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Alkasite Restoration Material (Cention N) and Self-cure Composite (Stela; SDI) Compared to Conventional Composite and Resin-modified Glass Ionomer in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07504393
- Acronym / sponsor ID
- AAU-PEDO-1394-5575
- Conditions
- Dental Caries, Primary Molars
- Keywords
- stela, Primary molars, Pediatric dentistry, Direct restoration, Cention N, Nanohybrid composite, Resin-modified glass ionomer, FDI criteria
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 Mar 2026 (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 randomized clinical trial aims to compare the clinical and radiographic performance of four direct restorative materials used for restoring carious primary molars in children. Eligible children aged 4-8 years with posterior primary molars requiring direct restoration will be randomly allocated (1:1:1:1) to receive one of the following materials: an alkasite restorative material (Cention N), a self-cure bulk-fill resin composite (Stela; SDI), a conventional light-cured nanohybrid resin composite (Beautifil II), or a resin-modified glass ionomer cement (Riva Light Cure). Restorations will be evaluated using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria. Postoperative sensitivity will be assessed at 48 hours using a 0-10 visual analogue scale (VAS). Clinical and radiographic follow-up assessments will be conducted at baseline and at scheduled recall visits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four-arm, parallel-group randomized clinical trial (1:1:1:1).
| Arm | Type | Receives |
|---|---|---|
| Group A: Cention N | Experimental | Device: Cention N |
| Group B: Stela (Self-cure Bulk-fill Composite) | Experimental | Device: Stela, SDI, Australia |
| Group C: Beautifil II (Nanohybrid Composite) | Active comparator | Device: Beautifil II, Shofu, Japan |
| Group D: Riva Light Cure (RMGIC) | Active comparator | Device: Resin modified glass ionomer cement |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 4-8 years old.
- Primary molars indicated for restorative treatment.
- No pulp involvement or history of dental pain.
- Cooperative children (Frankl: +ve or ++ve).
Key exclusion criteria (2 listed)
- Pulp exposure after caries removal or clinical signs of irreversible pulpitis/necrosis.
- Severe developmental enamel defects or insufficient enamel for bonding.
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 |
|---|---|---|
| Cention NAlso: Ivoclar VivadentAlkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions. | Device | Group A: Cention N |
| Stela, SDI, AustraliaSelf-cure bulk-fill resin composite (Stela; SDI) used for direct restoration of carious primary molars according to the manufacturer's instructions. | Device | Group B: Stela (Self-cure Bulk-fill Composite) |
| Beautifil II, Shofu, JapanLight-cured nanohybrid resin composite (Beautifil II) used for direct restoration of carious primary molars according to the manufacturer's instructions. | Device | Group C: Beautifil II (Nanohybrid Composite) |
| Resin modified glass ionomer cementResin-modified glass ionomer cement (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions. | Device | Group D: Riva Light Cure (RMGIC) |
Primary outcome
Restoration success based on FDI criteria (clinical and radiographic evaluation)
Time frame: 6 months
Restoration success based on FDI criteria (clinical and radiographic evaluation)
Time frame: 6 months
Clinical and radiographic success of restorations assessed using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria (scores 1-5). Scores 1-3 are considered clinically acceptable; scores 4-5 are considered clinically unacceptable (repair or replacement indicated).
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 31 Mar 2026.
- Individual participant dataSharing planned: No. individual participant data will not be shared to protect participant privacy and confidentiality, in accordance with the informed consent provided by the participants and the ethical approval granted for this study
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cention N, Stela, SDI, Australia and Beautifil II, Shofu, Japan in people with Dental Caries and Primary Molars, run by Al-Azhar 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 4 inclusion and 2 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 31 Mar 2026. 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?
Contact Hosam Hassan Metwalli (+201147957878, dr.hosamhassan2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration success based on FDI criteria (clinical and radiographic evaluation) (time frame: 6 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 31 Mar 2026.