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NCT04796974
Clinical Evaluation of "Cention Forte" Restorative Material
NA trial testing Cention in Caries in 50 participants. Participants enrolled and being followed up; not accepting new ones.
8 June 2022
Quick facts
| Lead sponsor | Istanbul Medipol University Hospital |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 8 March 2021 |
| Primary completion | 8 June 2022 |
| Estimated completion | 8 July 2025 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Cention
Conditions studied
- Caries — all drugs for Caries →
- Unsatisfactory or Defective Restoration of Tooth — all drugs for Unsatisfactory or Defective Restoration of Tooth →
Sponsor
Istanbul Medipol University Hospital
Who can join
18 and older, any sex, with Caries or Unsatisfactory or Defective Restoration of Tooth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04796974
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04796974 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istanbul Medipol University Hospital
- Last refreshed: 10 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04796974.
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