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Trial registered on ANZCTR


Registration number
ACTRN12624000653561
Ethics application status
Approved
Date submitted
19/03/2024
Date registered
21/05/2024
Date last updated
21/05/2024
Date data sharing statement initially provided
21/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical study to evaluate the effect of a bioactive restoration material in restoration of dental root caries
Scientific title
Evaluating the clinical performance: retention rate, marginal adaptation, marginal staining, recurrence of caries and fracture of a bioactive restoration material (BioUnion Filler) in carious cervical lesions restorations in healthy non smoking patients without bruxism or any oral para-functional habits
Secondary ID [1] 311763 0
Nil known
Universal Trial Number (UTN)
U1111-1305-7568
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical dental caries 333267 0
Condition category
Condition code
Oral and Gastrointestinal 329963 329963 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
The researcher himself will do the restorations of 40 teeth that will be divided into two groups randomly (20 restorations in each group) and the following will be done in the study group:
- Vitality test (using ethyl chloride on a cotton pellet on the middle third of the facial surface of the tooth)
- Apply local anesthesia
- Isolation with cotton rolls and retraction cords or using rubber dam
- Mechanical preparation and complete caries removal until reaching a clean and caries-free surface
- Applying glass ionomer cement (GIC) BioUnion Filler (Caredyne-Restore, GC Corporation, Tokyo, Japan) to every cavity in the intervention group and filling the entire cavity until a smooth surface is reached and it is consistent with the original tooth surface
- Finishing and polishing after 24 hours
follow ups for clinical evaluation of the restorations will be in (3 months, 6 months, 9 months, and 12 moths)
Intervention code [1] 328218 0
Treatment: Other
Comparator / control treatment
The researcher himself will do the restorations of 40 teeth that will be divided into two groups randomly (20 restoration in each group) and the following will be done in the control group:
- Vitality test (using ethyl chloride on a cotton pellet on the middle third of the facial surface of the tooth)
- Apply local anesthesia
- Isolation with cotton rolls and retraction cords or using rubber dam
- Mechanical preparation and complete caries removal until reaching a clean and caries-free surface
- Applying (GIC) Fuji IX GP® (GC Corporation, Tokyo, Japan) to every cavity until a smooth surface is reached and it is consistent with the original tooth surface
- Finishing and polishing after 24 hours
follow ups for clinical evaluation of the restorations will be in (3 months, 6 months, 9 months, and 12 moths)
Control group
Active

Outcomes
Primary outcome [1] 337720 0
Retention rate
Timepoint [1] 337720 0
1 week (Baseline), 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, and 1 year post-intervention (primary timepoint)
Secondary outcome [1] 432964 0
Marginal adaptation
Timepoint [1] 432964 0
1 week (Baseline), 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, and 1 year post-intervention
Secondary outcome [2] 432965 0
Marginal staining
Timepoint [2] 432965 0
1 week (Baseline), 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, and 1 year post-intervention
Secondary outcome [3] 432966 0
Secondary caries
Timepoint [3] 432966 0
1 week (Baseline), 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, and 1 year post-intervention
Secondary outcome [4] 432967 0
Restoration fracture
Timepoint [4] 432967 0
1 week (Baseline), 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, and 1 year post-intervention

Eligibility
Key inclusion criteria
-patient with minimum age 19
- cervical carious lesions (up to 40% of the lesion on root)
- lesion depth not less than 1 mm
- the lesion must be on:
lower or upper molars
lower or upper premolars
and lower canines only
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- history of tooth hypersensitivity
- periapical or periodontal diseases
- necrotic pulp and endodonticaly treated teeth
- previous restorations
- bruxism
- pregnancy
- sensitivity to any material in the study
- smokers
- using orthodontic appliances

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 intervention will be determined by opening a sealed envelope -after finishing the cavity preparation- determining what material will be used for this tooth.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be done using coin-tossing for the first eligible tooth for the study in the patient mouth starting from the upper right quadrant
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
10/05/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26208 0
Syrian Arab Republic
State/province [1] 26208 0
Damascus

Funding & Sponsors
Funding source category [1] 316098 0
University
Name [1] 316098 0
Damascus University
Country [1] 316098 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Country
Syrian Arab Republic
Secondary sponsor category [1] 318266 0
None
Name [1] 318266 0
Address [1] 318266 0
Country [1] 318266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314925 0
Ethical and scientific committee of dental research of Damascus University
Ethics committee address [1] 314925 0
Mazzah highway, Fayez Mansour street, Damascus, Syria
Ethics committee country [1] 314925 0
Syrian Arab Republic
Date submitted for ethics approval [1] 314925 0
12/04/2022
Approval date [1] 314925 0
09/05/2022
Ethics approval number [1] 314925 0
2619

Summary
Brief summary
BioUnion Filler is a relatively new restoration material that is known to be the first commercially available bioactive glass-ionomer cement. The manufacturing company recommends using BioUnion Filler in high risk caries patients because of its important characteristic of releasing Zn2+ and Ca2+ in high acidic environment.

This study was designed to evaluate the clinical performance of this material in carious cervical lesions by comparing it to GIC (Fuji IX).

Information about oral and tooth brushing habits along with gingival bleeding status will be collected for each patient
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133150 0
Dr Ahmed Ballouk
Address 133150 0
work organisation address : Damascus university.Syria, Damascus, Mazzeh, Fayez Mansour street.
Country 133150 0
Syrian Arab Republic
Phone 133150 0
+963937414715
Fax 133150 0
Email 133150 0
[email protected]
Contact person for public queries
Name 133151 0
Ahmed Ballouk
Address 133151 0
work organisation address : Syria, Damascus, Mazzeh, Fayez Mansour street.
Country 133151 0
Syrian Arab Republic
Phone 133151 0
+963937414715
Fax 133151 0
Email 133151 0
[email protected]
Contact person for scientific queries
Name 133152 0
Ahmed Ballouk
Address 133152 0
work organisation address : Damascus university.Syria, Damascus, Mazzeh, Fayez Mansour street.
Country 133152 0
Syrian Arab Republic
Phone 133152 0
+963937414715
Fax 133152 0
Email 133152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.