Dental Restoration FailureNCT06273410
Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive
A study testing Cention N, Cention N + Adhesive and Bulk Fill Composite in people with Dental Restoration Failure, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- Cention N, Cention N + Adhesive and Bulk Fill Composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Oct 2022to 28 Nov 2023
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Permanent molars with occlusal pit and fissure caries.
- Good oral hygiene.
- Occlusal contact with antagonist teeth.
Who cannot join
- Permanent molars with occlusal pit and fissure caries.
- Good oral hygiene.
- Age between 18- 45 years.
- Occlusal contact with antagonist teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive (A Randomized Controlled Clinical Trial)
Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions \& reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) \& Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial.
- Conditions
- Dental Restoration Failure
- Being tested
- Cention N, Cention N + Adhesive, Bulk Fill Composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cention NOther
Cention N will be manipulated using the standard powder: liquid ratio which is, one scoop of powder with one drop of liquid. Powder and liquid will be dispensed on the mixing pad and mixed using a plastic spatula according to the manufacturer's instruction for 45-60 seconds
Cention N + AdhesiveOther
Cavity will be rinsed with water to remove all residue. Etchant will be applied onto the prepared cavity for 15 seconds and thoroughly rinsed with water spray and gently dried with air jet. A layer of Tetric N Bond universal will be applied on the enamel \& dentin surface using a disposable applicator, the material will be gently brushed into dentin for at least 10 seconds
Bulk Fill CompositeOther
Cavity will be rinsed with water to remove all residue. Etchant will be applied onto the prepared cavity for 15 seconds and thoroughly rinsed with water spray and gently dried with air jet. A layer of Tetric N Bond universal will be applied on the enamel \& dentin surface using a disposable applicator, the material will be gently brushed into dentin for at least 10 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Cention N without adhesive. | Experimental | Not described Receives: Other: Cention N |
| Cention N with adhesive | Experimental | Not described Receives: Other: Cention N + Adhesive |
| Filtek Bulk Fill posterior composite | Active comparator | Not described Receives: Other: Bulk Fill Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain sensitivity
Air spray will be applied from a 2-mm distance on to the occlusal surface for 35seconds and should always be compared with the reaction of adjacent vital teeth. The severity of patients' pain/sensitivity will be recorded and given a score from 1 to 5
Measured: 1 week, after 3, 6 and 12 months
Change in occurrence of recurrent caries
All surfaces were dried prior to evaluation. The restorations' assessment will be performed using a dental mirror and a ball-point probe aided by periapical radiographs.
Measured: 1 week, after 3, 6 and 12 months
Change in occurrence of marginal stains
It is recommended to ask the patient about dietary habits. The restoration surface will be evaluated with regard to staining by comparison with the surrounding hard tissues and will be performed by the means of visual inspection aided with intraoral photography
Measured: 1 week, after 3, 6 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 posted22 Feb 2024
- Study start13 Oct 2022
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
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 Dental Restoration FailureStudies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273410
- Sponsor's protocol ID
- 0453-6/2022
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El-Salamouny NA, Elmahy WA, Holiel AA. Comparative evaluation of bioactive alkasite-based material in different application modes: a 1-year randomized controlled clinical trial. Odontology. 2025 Oct;113(4):1689-1700. doi: 10.1007/s10266-025-01095-4. Epub 2025 Apr 15.
PubMed 40229532
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06273410
- Acronym / sponsor ID
- 0453-6/2022
- Conditions
- Dental Restoration Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 22 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.
Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions \& reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) \& Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cention N without adhesive. | Experimental | Other: Cention N |
| Cention N with adhesive | Experimental | Other: Cention N + Adhesive |
| Filtek Bulk Fill posterior composite | Active comparator | Other: Bulk Fill Composite |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Permanent molars with occlusal pit and fissure caries.
- Good oral hygiene.
- Occlusal contact with antagonist teeth.
Key exclusion criteria (4 listed)
- Permanent molars with occlusal pit and fissure caries.
- Good oral hygiene.
- Age between 18- 45 years.
- Occlusal contact with antagonist teeth.
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 NCention N will be manipulated using the standard powder: liquid ratio which is, one scoop of powder with one drop of liquid. Powder and liquid will be dispensed on the mixing pad and mixed using a plastic spatula according to the manufacturer's instruction for 45-60 seconds | Other | Cention N without adhesive. |
| Cention N + AdhesiveCavity will be rinsed with water to remove all residue. Etchant will be applied onto the prepared cavity for 15 seconds and thoroughly rinsed with water spray and gently dried with air jet. A layer of Tetric N Bond universal will be applied on the enamel \& dentin surface using a disposable applicator, the material will be gently brushed into dentin for at least 10 seconds | Other | Cention N with adhesive |
| Bulk Fill CompositeCavity will be rinsed with water to remove all residue. Etchant will be applied onto the prepared cavity for 15 seconds and thoroughly rinsed with water spray and gently dried with air jet. A layer of Tetric N Bond universal will be applied on the enamel \& dentin surface using a disposable applicator, the material will be gently brushed into dentin for at least 10 seconds. | Other | Filtek Bulk Fill posterior composite |
Primary outcome
Change in pain sensitivity
Time frame: 1 week, after 3, 6 and 12 months
Air spray will be applied from a 2-mm distance on to the occlusal surface for 35seconds and should always be compared with the reaction of adjacent vital teeth. The severity of patients' pain/sensitivity will be recorded and given a score from 1 to 5
Change in occurrence of recurrent caries
Time frame: 1 week, after 3, 6 and 12 months
All surfaces were dried prior to evaluation. The restorations' assessment will be performed using a dental mirror and a ball-point probe aided by periapical radiographs.
Change in occurrence of marginal stains
Time frame: 1 week, after 3, 6 and 12 months
It is recommended to ask the patient about dietary habits. The restoration surface will be evaluated with regard to staining by comparison with the surrounding hard tissues and will be performed by the means of visual inspection aided with intraoral photography
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 22 Feb 2024.
- Derived from this study: PubMed 40229532El-Salamouny NA, Elmahy WA, Holiel AA. Comparative evaluation of bioactive alkasite-based material in different application modes: a 1-year randomized controlled clinical trial. Odontology. 2025 Oct;113(4):1689-1700. doi: 10.1007/s10266-025-01095-4. Epub 2025 Apr 15.
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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 study testing Cention N, Cention N + Adhesive and Bulk Fill Composite in people with Dental Restoration Failure, run by Hams Hamed Abdelrahman 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 3 inclusion and 4 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 22 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.
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?
Change in pain sensitivity (time frame: 1 week, after 3, 6 and 12 months). The study lists 3 primary outcomes in all. 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 NCT06273410, 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 22 Feb 2024.