Pediatric DentistryCention-ForteNCT07355920
Use of Alkasite for Postpulpotomy Restoration
A study testing Cention Forte and Tetric® N-Ceram in people with Pediatric Dentistry and Post Pulpotomy Restoration, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study will be directed to: Evaluate the clinical performance of alkasite composite as a final restoration for pulpotomized primary molars. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Dentistry, Post Pulpotomy Restoration
- What is being tested?
- Cention Forte and Tetric® N-Ceram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jan 2026to 1 Oct 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Deep carious vital primary molars at site 1, 2, and size 3 according to the SI/STA classification of caries.
- Healthy children free from systemic diseases.
- Cooperative patient: Frankel rating 3,4.
- Radiographically:
- Deep caries approximating the pulp.
- Roots with no more than one-third physiologic resorption.
- Normal lamina dura and periodontal ligament space.
Who cannot join
- Patients with bruxism.
- Clinical signs or symptoms of irreversible pulpitis or pulp degeneration.
- Parents refuse treatment.
- Radiographically:
- Furcation involvement.
- periapical lesion.
- Pathologic resorption (internal or external).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The clinical study was carried out at the clinic of Pediatric and Preventive Dentistry Department, Faculty of dentistry, Tanta university.
Tanta
About this study
Official title: Clinical Evaluation of Alkasite Composite as a Final Restoration for Pulpotomized Primary Molars.
The aim of this study will be directed to:
Evaluate the clinical performance of alkasite composite as a final restoration for pulpotomized primary molars.
- Conditions
- Pediatric Dentistry, Post Pulpotomy Restoration
- Being tested
- Cention Forte, Tetric® N-Ceram
- Keywords
- cention forte, tetric n ceram, alkasite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cention ForteProcedure or surgery
Also called alkasite
25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy.
Tetric® N-CeramProcedure or surgery
Also called bulk-fill composite
5 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Study group :Alkasite( cention forte ) | Experimental | 25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy. Receives: Procedure: Cention Forte |
| Group II :Control group: Tetric N-Ceram | Active comparator | 25 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy. Receives: Procedure: Tetric® N-Ceram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of the final restoration according to USPHS Criteria
Clinical evaluation of the final restoration is done according to the modified united states public health service USPHS Criteria for direct clinical evaluation of restoration
Measured: at 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start27 Jan 2026
- Primary completion30 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric DentistryStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Taha Mokhtar Hamed Elsayed, Tanta University
- Investigators
- Faten Abu Taleb, Study chair, faculty of dentistry Tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355920
- Sponsor's protocol ID
- #P-PED-6-24-2204
- Acronym
- Cention-Forte
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaur K, Suneja B, Jodhka S, Saini RS, Chaturvedi S, Bavabeedu SS, Alhamoudi FH, Cicciu M, Minervini G. Comparison between Restorative Materials for Pulpotomised Deciduous Molars: A Randomized Clinical Study. Children (Basel). 2023 Feb 1;10(2):284. doi: 10.3390/children10020284.
PubMed 36832414
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Alkasite Composite as a Final Restoration for Pulpotomized Primary Molars.
- ClinicalTrials.gov ID
- NCT07355920
- Acronym / sponsor ID
- Cention-Forte / #P-PED-6-24-2204
- Conditions
- Pediatric Dentistry, Post Pulpotomy Restoration
- Keywords
- cention forte, tetric n ceram, alkasite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 21 Jan 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.
The aim of this study will be directed to:
Evaluate the clinical performance of alkasite composite as a final restoration for pulpotomized primary molars.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Study group :Alkasite( cention forte ) | Experimental | Procedure: Cention Forte25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy. |
| Group II :Control group: Tetric N-Ceram | Active comparator | Procedure: Tetric® N-Ceram25 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Deep carious vital primary molars at site 1, 2, and size 3 according to the SI/STA classification of caries.
- Healthy children free from systemic diseases.
- Cooperative patient: Frankel rating 3,4.
- Deep caries approximating the pulp.
- Roots with no more than one-third physiologic resorption.
Key exclusion criteria (7 listed)
- Patients with bruxism.
- Clinical signs or symptoms of irreversible pulpitis or pulp degeneration.
- Parents refuse treatment.
- Furcation involvement.
- periapical lesion.
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 ForteAlso: alkasite25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy. | Procedure or surgery | Group I: Study group :Alkasite( cention forte ) |
| Tetric® N-CeramAlso: bulk-fill composite5 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy. | Procedure or surgery | Group II :Control group: Tetric N-Ceram |
Primary outcome
Clinical evaluation of the final restoration according to USPHS Criteria
Time frame: at 3, 6, and 9 months
Clinical evaluation of the final restoration is done according to the modified united states public health service USPHS Criteria for direct clinical evaluation of restoration
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 5 Oct 2026.
- Background: PubMed 36832414Kaur K, Suneja B, Jodhka S, Saini RS, Chaturvedi S, Bavabeedu SS, Alhamoudi FH, Cicciu M, Minervini G. Comparison between Restorative Materials for Pulpotomised Deciduous Molars: A Randomized Clinical Study. Children (Basel). 2023 Feb 1;10(2):284. doi: 10.3390/children10020284.
- 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.
Faten Abu Taleb study chair
faculty of dentistry Tanta 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 Cention Forte and Tetric® N-Ceram in people with Pediatric Dentistry and Post Pulpotomy Restoration, run by Tanta 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 7 inclusion and 7 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 5 Oct 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?
Clinical evaluation of the final restoration according to USPHS Criteria (time frame: at 3, 6, and 9 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 NCT07355920, which also lists 1 linked publication.
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 5 Oct 2026.