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Trial registered on ANZCTR


Registration number
ACTRN12619001650189
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
26/11/2019
Date last updated
26/11/2019
Date data sharing statement initially provided
26/11/2019
Date results information initially provided
26/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical performance of crowns fabricated using different method in restoring pulp treated primary molars.
Scientific title
Clinical Performance of of three full-coronal restorations using (polymethylmethacrylate “PMMA”, three dimension printable light curing composite and direct composite Celluloid Crowns) in Rehabilitation of a Large Carious Primary Molar.
Secondary ID [1] 299383 0
None
Universal Trial Number (UTN)
U1111-1240-8512
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary teeth crowns 314555 0
Condition category
Condition code
Oral and Gastrointestinal 312894 312894 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
Eligible teeth with cavitated carious lesion needed for pulp treatment and full coverage restoration with crowns in primary teeth will be randomly divided into 3 groups:

- Selected teeth crowned with poly methyl methacrylate (PMMA) based crowns fabricated using Computer-Aided Design/Computer-Assisted Manufactured (CAD\CAM), arm 1
- Selected teeth crowned with using three dimensional printable bio-compatible light curing composite crowns fabricated using three dimensional dental printer(3D Dental printer), arm 2
- Selected teeth crowned using direct resin composite Celluloid crowns , arm 3

Each participant will be assigned to one treatment group to avoid the possible synergetic effect of the different agents.

Local anesthesia was achieved. The teeth were isolated using a rubber dam. The selected extensively carious primary molars will be endodontically treated and restored with glass-ionomer cement (Fuji IX, GC, Tokyo, Japan), tooth preparation will be performed and an impression is taking, then the crowns would be fabricated in dental lab in arm 1 and arm 2, however, in arm 3 the teeth crowned using direct resin composite strip crown without impression and dental lab works.
All procedures will be administered by pediatric dentist
All the crowns will be evaluated at baseline and then at 3, 6, and 12 months using ‘modified FDI by two independent investigators for clinical success and quality of the crowns.
Intervention code [1] 315644 0
Rehabilitation
Intervention code [2] 316078 0
Treatment: Other
Comparator / control treatment
Arm 3. direct resin composite Celluloid crowns.
Control group
Active

Outcomes
Primary outcome [1] 321498 0
Crown durability
The measure will be done by blinded investigators using United States Public Health Service (USPHS) by two independent investigators for clinical success and quality of the crowns.
Timepoint [1] 321498 0
(T0) Baseline and re-evaluate in three times interval stages:
(T1) 3 months after cementing the crowns
(T2) 6 months after cementing the crowns
(T3) 12 months after cementing the crowns
Primary outcome [2] 321969 0
gingival assessment
The measure will be done by blinded investigators using United States Public Health Service (USPHS) by two independent investigators for clinical success and quality of the crowns.
Timepoint [2] 321969 0
(T0) Baseline and re-evaluate in three times interval stages:
(T1) 3 months after cementing the crowns
(T2) 6 months after cementing the crowns
(T3) 12 months after cementing the crowns
Secondary outcome [1] 376841 0
parents post-operative acceptability and dental chair side time,
Assessment using Visual analogue scale (VAS) scale
Timepoint [1] 376841 0
Baseline, immediately after cementing the crowns
Secondary outcome [2] 376842 0
secondary caries
Assessment according to modified United States Public Health Service (USPHS).
Timepoint [2] 376842 0
(T0) Baseline and re-evaluate in three times interval stages:
(T1) 3 months after cementing the crowns
(T2) 6 months after cementing the crowns
(T3) 12 months after cementing the crowns

Eligibility
Key inclusion criteria
1. extensively carious primary second molar (more than two carious surfaces) requiring endodontic treatment and crowning.
2. Good oral hygiene.
3. Co-operative patients approving the trial (definitely positive- positive) according to the Frankl behavior classification scale..
Minimum age
4 Years
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. primary molars with missing antagonist, mobility, sinus or abscess.
2 children with known systemic disease, mental disability or abnormal para-functional habits
3 patient who had the behavioral rating “definitely negative” according to the Frankl behavior classification scale.

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization for children will be done using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Sample size was calculated using g-power 3.1 software. The significance level was set at 0.05 and the power of the study was set to be 0.80.
Based on a one-way Anova test, it was estimated that 75 patients were required to demonstrate an effect size (0.4).

Statistical analyses will be performed using the statistical software SPSS for Windows (version 25.0, SPSS Inc.,Chicago,IL,USA).

- The normality of distribution of the date will be verified by Kolmogorov-Smirnov normality test.
- If the data were normally distributed, One-way Anova test will be applied. Deviations from baseline will be tested for significance with the Bonferroni post hoc test.
- if the data were not normally distributed, kruskal wallis test will be applied. Deviations from baseline will be tested for significance with the Wilcoxon Signed Rank Matched Pairs Test.
- Interrater reliability will be tested using Cohen's Kappa measure.
- The level of significance will be set at 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21883 0
Syrian Arab Republic
State/province [1] 21883 0
Damascus

Funding & Sponsors
Funding source category [1] 303896 0
University
Name [1] 303896 0
Damascus University
Address [1] 303896 0
Dental College, Damascus University"work organisation", Al-Mazzeh street., Damascus, Syria.
Country [1] 303896 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental College, Damascus University"work organisation", Al-Mazzeh street., Damascus, Syria.
Country
Syrian Arab Republic
Secondary sponsor category [1] 304044 0
None
Name [1] 304044 0
None
Address [1] 304044 0
None
Country [1] 304044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304402 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 304402 0
Dental College, Damascus University, Al-Mazzeh Street, Damascus, Syria
Ethics committee country [1] 304402 0
Syrian Arab Republic
Date submitted for ethics approval [1] 304402 0
20/12/2018
Approval date [1] 304402 0
21/01/2019
Ethics approval number [1] 304402 0

Summary
Brief summary
The aim of this study is to evaluate and compare the clinical outcomes of three full-coronal restorations using (polymethylmethacrylate “PMMA”, 3D printable biocompatible light curing composite and direct composite Celluloid Crowns) over 3, 6, and 12 months regarding recovery failure, marginal integrity, occlusion, and gingival response.
Randomized controlled clinical trial
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96822 0
Dr M-NOUR ALHALABI
Address 96822 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 96822 0
Syrian Arab Republic
Phone 96822 0
+963946459369
Fax 96822 0
Email 96822 0
dr.m.nour.h@gmail.com
Contact person for public queries
Name 96823 0
Dr M-NOUR ALHALABI
Address 96823 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 96823 0
Syrian Arab Republic
Phone 96823 0
+963946459369
Fax 96823 0
Email 96823 0
dr.m.nour.h@gmail.com
Contact person for scientific queries
Name 96824 0
Dr M-NOUR ALHALABI
Address 96824 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 96824 0
Syrian Arab Republic
Phone 96824 0
+963946459369
Fax 96824 0
Email 96824 0
dr.m.nour.h@gmail.com

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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5047 0
Study protocol
Citation [1] 5047 0
Link [1] 5047 0
Email [1] 5047 0
dr.m.nour.h@gmail.com
Other [1] 5047 0
Attachment [1] 5047 0
Type [2] 5048 0
Ethical approval
Citation [2] 5048 0
Link [2] 5048 0
Email [2] 5048 0
dr.m.nour.h@gmail.com
Other [2] 5048 0
Attachment [2] 5048 0
Type [3] 5049 0
Informed consent form
Citation [3] 5049 0
Link [3] 5049 0
Email [3] 5049 0
dr.m.nour.h@gmail.com
Other [3] 5049 0
Attachment [3] 5049 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary