Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000678493
Ethics application status
Approved
Date submitted
17/05/2025
Date registered
26/06/2025
Date last updated
26/06/2025
Date data sharing statement initially provided
26/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the Impact of Cention N on Dental Caries Management: A Clinical Study
Scientific title
Clinical performance evaluation of bioactive restorative material Cention N in the restoration of occlusal carious lesions. A split-mouth randomized controlled clinical trial
Secondary ID [1] 314473 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Caries 337511 0
Condition category
Condition code
Oral and Gastrointestinal 333878 333878 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331096 0
Treatment: Other
Comparator / control treatment
The occlusal surface caries in the control group will be restored using Ivoclar Vivadent Tetric N-Ceram composite, a light-cured, premixed, non-bioactive filling material.
The clinical performance of these restorations will subsequently be evaluated in the oral environment according to modified United States Public Health Service (USPHS) criteria.
Control group
Active

Outcomes
Primary outcome [1] 341503 0
The restoration remains intact in the oral cavity.
Timepoint [1] 341503 0
Baseline, 3 months, 6 months, and 9 months after the intervention
Secondary outcome [1] 447794 0
Teeth sensitivity
Timepoint [1] 447794 0
Basline and one week after the intervention

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of rampant caries and poor oral hygiene.
2. Presence of advanced periodontal disease.
3. Presence of signs of xerostomia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients will be examined to identify the eligible teeth
Allocation will be done using sealed opaque envelopes
Inside each envelope, there is the code of the group that the tooth will be in
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2024
Date of last participant enrolment
Anticipated
Actual
1/09/2024
Date of last data collection
Anticipated
29/06/2025
Actual
Sample size
Target
48
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 27068 0
Syrian Arab Republic
State/province [1] 27068 0

Funding & Sponsors
Funding source category [1] 319134 0
Self funded/Unfunded
Name [1] 319134 0
Unfunded
Country [1] 319134 0
Primary sponsor type
University
Name
Damascus University
Address
Country
Syrian Arab Republic
Secondary sponsor category [1] 321601 0
None
Name [1] 321601 0
Address [1] 321601 0
Country [1] 321601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317622 0
Ethical and scientific committee of dental research of Damascus University
Ethics committee address [1] 317622 0
Ethics committee country [1] 317622 0
Syrian Arab Republic
Date submitted for ethics approval [1] 317622 0
29/03/2024
Approval date [1] 317622 0
15/04/2024
Ethics approval number [1] 317622 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141598 0
Dr Tareq Abo Alshaar
Address 141598 0
Damascus University, Mazzah Highway, Fayez Mansour Street
Country 141598 0
Syrian Arab Republic
Phone 141598 0
+963 937065023
Fax 141598 0
Email 141598 0
[email protected]
Contact person for public queries
Name 141599 0
Tareq Abo Alshaar
Address 141599 0
Damascus University, Mazzah Highway, Fayez Mansour Street
Country 141599 0
Syrian Arab Republic
Phone 141599 0
+963 937065023
Fax 141599 0
Email 141599 0
[email protected]
Contact person for scientific queries
Name 141600 0
Tareq Abo Alshaar
Address 141600 0
Damascus University, Mazzah Highway, Fayez Mansour Street
Country 141600 0
Syrian Arab Republic
Phone 141600 0
+963 937065023
Fax 141600 0
Email 141600 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.