CariesNCT04796974
Clinical Evaluation of "Cention Forte" Restorative Material
A study testing Cention in people with Caries and Unsatisfactory or Defective Restoration of Tooth, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Resin composites, the first choice of material for the restoration of posterior teeth, still have several drawbacks including their polymerization shrinkage and potential failure of the resin-dentin interface leading to secondary caries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries, Unsatisfactory or Defective Restoration of Tooth
- What is being tested?
- Cention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2021to 8 Jul 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vital tooth checked with sensibility test towards cold
- Proximal and/or occlusal caries lesion to be treated invasively or restoration that needs replacement (i.e. amalgam, composite, glass-ionomer)
- Class I \& II restorations in premolar and molars (at least 75% Class II).
- Maximum 2 fillings with Cention in each patient
- No obvious untreated caries in the rest of the dentition, dental health problems (regularly checked by a dentist)
- Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment) Moderate or high caries activity: DMFS equivalent or higher than mean DMFS of the population of the same age group in the same region or city.
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- No untreated periodontal disease (only DPSI 1, 2)
- Subjects had to be over the age of 18, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with moderate to good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
- Appropriate isolation after cavity preparations
- Subjects had to agree to keep the scheduled recall appointments for data collection and maintenance and plan to stay in the area for at least 3 years.
Who cannot join
- Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3
- Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
- Endodontic treatment
- Pulp exposure or near pulp exposure
- Patients who want to bleach their teeth or bleached teeth less than 3 weeks ago
- Extremely hypersensitive tooth (s. below) / Pulpitis 7 VAS (visual analog scale) >3 on temperature and/or biting
Show all 11Show fewer
- Excluding the teeth, without opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
- Subjects who presented with severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism
- Subjects undergoing orthodontic treatment
- Subjects who are pregnant or breast feeding during the duration of the study
- Subjects who are known to be allergic to the ingredients of resin materials
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Dental Hospital
Istanbul, 34083
About this study
Official title: Clinical Evaluation of "Cention Forte" Restorative Material in Class I and II Cavities: A Prospective Controlled Clinical Trial up to 3 Years
Resin composites, the first choice of material for the restoration of posterior teeth, still have several drawbacks including their polymerization shrinkage and potential failure of the resin-dentin interface leading to secondary caries. Time-saving and simplified restorative procedures are an ongoing demand for posterior applications.The bulk-fill resin based composites (BF-RBCs), has been developed with an attempt to speed up the restoration process by enabling up to 4- or 5-mm thick increments to be cured in one step. The photo-polymerized single-step BF-RBC materials seem to have some limitations in terms of adequate polymerization.
Therefore, recently, the use of dual-polymeritzed RBCs that are also suitable for bulk-fill application with additional bioactive properties such as acid-neutralizing ion release has been offered as an alternative to photo-polymerized ones. Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) restorative material is one approach that has been introduced as a new material category for this purpose. The hand mixed form is named as Cention N whereas auto-mixed capsule form is Cention. Both of them are resin based composite materials categorised as 'alkasite'. They are self-curing composites with optional photo-polymerzation for full volume (bulk) placement. Their composition is same with only exception of the concentration of the initiators and the powder liquid proportion. Cention is delivered together with Cention Primer to ensures the retention of the filling independent of the preparation.
The objective of this prospective clinical trial is to evaluate the clinical performance of Cention and Cention Primer in restoration of Class I and II cavities.
Read the detailed description
The aim of the study is to place at least 90 posterior restorations with Cention (in at least 45 patients). The patients will be informed about the study and ask to sign the Informed Consent. After having the initial radiographs and images, the preperation will be performed by standard procedures. As the cavity preparation is finished the measurement of the cavity dimensions will be performed by using a periodontal probe. After having the cavity images the cavity will be restored by Cention according to the manufacturer's instructions. Following the occlusal adjustment final image of the restoration will be taken.
After 2 weeks the patient will be recalled in order to asses the baseline FDI criteria by two observers. This recall appointment will be done annually up to 3 years.
- Being tested
- Cention
- Keywords
- Restorative materials, Clinical trial, Survival, Alcasites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentionDevice
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Basic Filling Material). Procedures will be done using local anesthesia. The cavity is excavated and filled according to the guidelines for ordinary restorative techniques
| Study group | Role | What they receive |
|---|---|---|
| Cention | Experimental | Alcasite restorative material Receives: Device: Cention |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI (World Dental Federation) criteria for dental restorations assessment
2 independent evaluators The primary outcome will consist in the FDI (World Dental Federation) instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start8 Mar 2021
- Primary completion8 Jun 2022
- Study completion8 Jul 2025 (estimated)
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 CariesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Responsible party
- Principal investigator, Funda Ozturk Bozkurt, Istanbul Medipol University Hospital
- Investigators
- Mutlu Özcan, DDS, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796974
- Sponsor's protocol ID
- 365559
- Status last verified
- Jul 2024
- First submitted
- 11 Mar 2021
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gozetici-Cil B, Balli-Akgol B, Ustun N, Kusdemir M, Ozturk-Bozkurt F, Ozcan M. Clinical Evaluation of an Alkasite-Based Resin Composite in Class I and II Cavities Conditioned with Self-Curing Primer: Preliminary Results up to One Year. Oper Dent. 2025 Mar 1;50(2):132-143. doi: 10.2341/24-034-C.
PubMed 40193558
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of "Cention Forte" Restorative Material in Class I and II Cavities: A Prospective Controlled Clinical Trial up to 3 Years
- ClinicalTrials.gov ID
- NCT04796974
- Acronym / sponsor ID
- 365559
- Keywords
- Restorative materials, Clinical trial, Survival, Alcasites
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jul 2025 (estimated)
- First posted
- 15 Mar 2021 (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.
Resin composites, the first choice of material for the restoration of posterior teeth, still have several drawbacks including their polymerization shrinkage and potential failure of the resin-dentin interface leading to secondary caries. Time-saving and simplified restorative procedures are an ongoing demand for posterior applications.The bulk-fill resin based composites (BF-RBCs), has been developed with an attempt to speed up the restoration process by enabling up to 4- or 5-mm thick increments to be cured in one step. The photo-polymerized single-step BF-RBC materials seem to have some limitations in terms of adequate polymerization.
Therefore, recently, the use of dual-polymeritzed RBCs that are also suitable for bulk-fill application with additional bioactive properties such as acid-neutralizing ion release has been offered as an alternative to photo-polymerized ones. Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) restorative material is one approach that has been introduced as a new material category for this purpose. The hand mixed form is named as Cention N whereas auto-mixed capsule form is Cention. Both of them are resin based composite materials categorised as 'alkasite'. They are self-curing composites with optional photo-polymerzation for full volume (bulk) placement. Their composition is same with only exception of the concentration of the initiators and the powder liquid proportion. Cention is delivered together with Cention Primer to ensures the retention of the filling independent of the preparation.
The objective of this prospective clinical trial is to evaluate the clinical performance of Cention and Cention Primer in restoration of Class I and II cavities.
Detailed description
The aim of the study is to place at least 90 posterior restorations with Cention (in at least 45 patients). The patients will be informed about the study and ask to sign the Informed Consent. After having the initial radiographs and images, the preperation will be performed by standard procedures. As the cavity preparation is finished the measurement of the cavity dimensions will be performed by using a periodontal probe. After having the cavity images the cavity will be restored by Cention according to the manufacturer's instructions. Following the occlusal adjustment final image of the restoration will be taken.
After 2 weeks the patient will be recalled in order to asses the baseline FDI criteria by two observers. This recall appointment will be done annually up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cention | Experimental | Device: CentionAlcasite restorative material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Vital tooth checked with sensibility test towards cold
- Proximal and/or occlusal caries lesion to be treated invasively or restoration that needs replacement (i.e. amalgam, composite, glass-ionomer)
- Class I \& II restorations in premolar and molars (at least 75% Class II).
- Maximum 2 fillings with Cention in each patient
- No obvious untreated caries in the rest of the dentition, dental health problems (regularly checked by a dentist)
Key exclusion criteria (11 listed)
- Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3
- Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
- Endodontic treatment
- Pulp exposure or near pulp exposure
- Patients who want to bleach their teeth or bleached teeth less than 3 weeks ago
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 |
|---|---|---|
| CentionTooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Basic Filling Material). Procedures will be done using local anesthesia. The cavity is excavated and filled according to the guidelines for ordinary restorative techniques | Device | Cention |
Primary outcome
FDI (World Dental Federation) criteria for dental restorations assessment
Time frame: 3 years
2 independent evaluators The primary outcome will consist in the FDI (World Dental Federation) instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 40193558Gozetici-Cil B, Balli-Akgol B, Ustun N, Kusdemir M, Ozturk-Bozkurt F, Ozcan M. Clinical Evaluation of an Alkasite-Based Resin Composite in Class I and II Cavities Conditioned with Self-Curing Primer: Preliminary Results up to One Year. Oper Dent. 2025 Mar 1;50(2):132-143. doi: 10.2341/24-034-C.
- 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.
Mutlu Özcan, DDS, PhD principal investigator
University of Zurich
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 in people with Caries and Unsatisfactory or Defective Restoration of Tooth, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Jul 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
FDI (World Dental Federation) criteria for dental restorations assessment (time frame: 3 years). 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 NCT04796974, 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 10 Jul 2024.