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Trial registered on ANZCTR


Registration number
ACTRN12622000321741
Ethics application status
Approved
Date submitted
14/01/2021
Date registered
21/02/2022
Date last updated
21/02/2022
Date data sharing statement initially provided
21/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Root-Canal-Supported Restorations in Endodontically Treated Anterior Primary Teeth in Children
Scientific title
Evaluating the Success of Fiber-Reinforced Composite Posts and Metal Posts Engaged by Computer-aided design & computer-aided manufacturing CAD-CAM in Comparison of Conventional Composite Used as Root-Canal-Supported Restorations in Endodontically Treated Anterior Primary Teeth in children
Secondary ID [1] 304759 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anterior primary teeth severe decay 319894 0
Condition category
Condition code
Oral and Gastrointestinal 317830 317830 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
new technique to restore endodontically treated primary anterior teeth using self-designed posts made of glass-reinforced composite (group D) and nickle-chrome discs (group C), and also the direct fiber-reinforced composite (group B). these techniques will be delivered by pedodontics.
the approximate duration of these procedures 20-30 minutes.
the longevity of treatments will be monitor by clinical check up.
Intervention code [1] 319176 0
Treatment: Other
Comparator / control treatment
traditional composite stabilizers and restorations. (group A)
delivered by pedodontics
making a composite posts in the root canal with 3 mm deep and then restoring the full crown with composite.
this technique uses only composite as a post and then a final restoration without supporting it with fibers.
Control group
Active

Outcomes
Primary outcome [1] 325849 0
12 posts of composites failed after one year follow up, determined by the posts retention.
the posts retention will be assessed by dentist review.
Timepoint [1] 325849 0
Baseline, 1 week post-procedure, 3 months post-procedure, 6 months post-procedure, 9 months poet-procedure, 1 year post-procedure (primary endpoint)
Primary outcome [2] 329624 0
3 posts of fiber-composite and 4 metal pots failed after one year follow up determined by retention of restorations.
the posts retention will be assessed by dentist review.
Timepoint [2] 329624 0
Baseline, 1 week post-procedure, 3 months post-procedure, 6 months post-procedure, 9 months poet-procedure, 1 year post-procedure (primary endpoint)
Secondary outcome [1] 405937 0
5 direct fiber-composite posts failed after one year determined by the retention of restoration.
the posts retention will be assessed by dentist review.
Timepoint [1] 405937 0
Baseline, 1 week post-procedure, 3 months post-procedure, 6 months post-procedure, 9 months poet-procedure, 1 year post-procedure (primary endpoint)

Eligibility
Key inclusion criteria
children with severely decayed anterior primary teeth with no history of trauma, no external or internal absorption, no developmental disorder.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
anterior primary teeth with initial caries, teeth with mobility,

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/08/2020
Date of last participant enrolment
Anticipated
Actual
20/01/2021
Date of last data collection
Anticipated
Actual
1/10/2021
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 23231 0
Syrian Arab Republic
State/province [1] 23231 0
Damascus

Funding & Sponsors
Funding source category [1] 307314 0
University
Name [1] 307314 0
Damascus University
Country [1] 307314 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
alBaramkeh, Damascus
Country
Syrian Arab Republic
Secondary sponsor category [1] 307950 0
None
Name [1] 307950 0
none
Address [1] 307950 0
none
Country [1] 307950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307405 0
Research Ethics Committee of faculty of Dentistry of Damascus University
Ethics committee address [1] 307405 0
Damascus University, alBaramkeh, Damascus, Syria
Ethics committee country [1] 307405 0
Syrian Arab Republic
Date submitted for ethics approval [1] 307405 0
30/07/2019
Approval date [1] 307405 0
22/12/2019
Ethics approval number [1] 307405 0
4295

Summary
Brief summary
Treatment of severely decayed anterior primary teeth has been a real challenge for pediatric dentists. This research aims to evaluate an innovative method to restore these case.
These teeth are enodontically treated and divided randomly into the 4 groups;
1-Group A contains teeth restoring by traditional composite with intracanal composite supporting post,
2-Group B includes teeth restoring by direct glass-fiber reinforced composite.
3-Group C contains teeth restoring by using pre-fabricated metal ringed posts and composite as a final restoration,
4-Group D includes teeth restoring by using pre-fabricated glass-fiber reinforced composite ringed posts and composite as a final restoration.
Clinical failure criteria:
1- The lack of permanence of the restoration
2- Pain spontaneously or upon examination: palpation - percussion
3- Symptoms of endodontic failure such as abscess - fistula – euphoria
Clinical failures are classified and the cause of failure determined in participants but they are not listed in the outcomes.
A value of 1 is given for success and a value of 0 for failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107118 0
Dr Jina Alfeel
Address 107118 0
department of pediatric dentistry, faculty of dentistry, Damascus university, almazzeh, Damascus, syria.
Country 107118 0
Syrian Arab Republic
Phone 107118 0
+963956499126
Fax 107118 0
Email 107118 0
[email protected]
Contact person for public queries
Name 107119 0
Jina Alfeel
Address 107119 0
department of pediatric dentistry, faculty of dentistry, Damascus university, almazzeh, Damascus, syria.
Country 107119 0
Syrian Arab Republic
Phone 107119 0
+963956499126
Fax 107119 0
Email 107119 0
[email protected]
Contact person for scientific queries
Name 107120 0
Jina Alfeel
Address 107120 0
department of pediatric dentistry, faculty of dentistry, Damascus university, almazzeh, Damascus, syria.
Country 107120 0
Syrian Arab Republic
Phone 107120 0
+963956499126
Fax 107120 0
Email 107120 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?




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.