Skip to content

Assessing the Impact of Cention N on Dental Caries Management: A Clinical Study

Clinical performance evaluation of bioactive restorative material Cention N in the restoration of occlusal carious lesions. A split-mouth randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000678493
Enrollment
48
Registered
2025-06-26
Start date
2024-06-01
Completion date
2024-09-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A randomized controlled clinical trial aimed to evaluate the clinical performance of new bioactive restorative material Cention N, compared to the standard nano hybrid composite Tetric N-Ceram. Marginal Integrity, Color Match, Surface Roughness, Fracture or Wear, Postoperative Sensitivity and Retention will be assessed over the period of 9 months The hypothesis of the study is that Cention N will provide acceptable clinical performance

Interventions

Following a thorough introduction of the procedure to the patients, including addressing all inquiries and obtaining informed consent, we will proceed with the restoration of occlusal caries in two teeth for each patient—one on each side. One tooth will be restored using Ivoclar Tetric N-Ceram composite, while the other will be treated with Ivoclar Cention N bioactive fluoride-releasing filling material, the bioactive fluoride-releasing Cention N is provided as a powder and liquid that must be m

Following a thorough introduction of the procedure to the patients, including addressing all inquiries and obtaining informed consent, we will proceed with the restoration of occlusal caries in two teeth for each patient—one on each side. One tooth will be restored using Ivoclar Tetric N-Ceram composite, while the other will be treated with Ivoclar Cention N bioactive fluoride-releasing filling material, the bioactive fluoride-releasing Cention N is provided as a powder and liquid that must be mixed immediately prior to application. Both restorations will be performed in a single appointment at the Faculty of Dentistry Clinics, Damascus University, by the researcher. The procedure will encompass the administration of local anesthesia, cavity preparation, and the complete removal of carious tissue, followed by restoration of the tooth under rubber dam isolation. The quality of the procedure and the final restorations will be evaluated by two independent dentists utilizing the modified United States Public Health Service (USPHS) criteria.

Sponsors

Damascus University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. The patient is over 18 years of age. 2. Oral hygiene is acceptable. 3. There are simple to moderate depth occlusal caries present 4. There is an opposing occlusion for the tooth.

Exclusion criteria

1. Presence of rampant caries and poor oral hygiene. 2. Presence of advanced periodontal disease. 3. Presence of signs of xerostomia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026