Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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.
Query!
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.
Query!
Secondary ID [1]
299383
0
None
Query!
Universal Trial Number (UTN)
U1111-1240-8512
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Primary teeth crowns
314555
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
312894
312894
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
315644
0
Rehabilitation
Query!
Intervention code [2]
316078
0
Treatment: Other
Query!
Comparator / control treatment
Arm 3. direct resin composite Celluloid crowns.
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
321498
0
Query!
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
Query!
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.
Query!
Assessment method [2]
321969
0
Query!
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
Query!
Secondary outcome [1]
376841
0
parents post-operative acceptability and dental chair side time,
Assessment using Visual analogue scale (VAS) scale
Query!
Assessment method [1]
376841
0
Query!
Timepoint [1]
376841
0
Baseline, immediately after cementing the crowns
Query!
Secondary outcome [2]
376842
0
secondary caries
Assessment according to modified United States Public Health Service (USPHS).
Query!
Assessment method [2]
376842
0
Query!
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
Query!
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..
Query!
Minimum age
4
Years
Query!
Query!
Maximum age
8
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Query!
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
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
20/06/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
19/09/2019
Query!
Date of last data collection
Anticipated
21/09/2020
Query!
Actual
Query!
Sample size
Target
75
Query!
Accrual to date
Query!
Final
75
Query!
Recruitment outside Australia
Country [1]
21883
0
Syrian Arab Republic
Query!
State/province [1]
21883
0
Damascus
Query!
Funding & Sponsors
Funding source category [1]
303896
0
University
Query!
Name [1]
303896
0
Damascus University
Query!
Address [1]
303896
0
Dental College, Damascus University"work organisation", Al-Mazzeh street., Damascus, Syria.
Query!
Country [1]
303896
0
Syrian Arab Republic
Query!
Primary sponsor type
University
Query!
Name
Damascus University
Query!
Address
Dental College, Damascus University"work organisation", Al-Mazzeh street., Damascus, Syria.
Query!
Country
Syrian Arab Republic
Query!
Secondary sponsor category [1]
304044
0
None
Query!
Name [1]
304044
0
None
Query!
Address [1]
304044
0
None
Query!
Country [1]
304044
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
304402
0
Ethical and Scientific Committee of dental research
Query!
Ethics committee address [1]
304402
0
Dental College, Damascus University, Al-Mazzeh Street, Damascus, Syria
Query!
Ethics committee country [1]
304402
0
Syrian Arab Republic
Query!
Date submitted for ethics approval [1]
304402
0
20/12/2018
Query!
Approval date [1]
304402
0
21/01/2019
Query!
Ethics approval number [1]
304402
0
Query!
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
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
96822
0
Dr M-NOUR ALHALABI
Query!
Address
96822
0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Query!
Country
96822
0
Syrian Arab Republic
Query!
Phone
96822
0
+963946459369
Query!
Fax
96822
0
Query!
Email
96822
0
[email protected]
Query!
Contact person for public queries
Name
96823
0
Dr M-NOUR ALHALABI
Query!
Address
96823
0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Query!
Country
96823
0
Syrian Arab Republic
Query!
Phone
96823
0
+963946459369
Query!
Fax
96823
0
Query!
Email
96823
0
[email protected]
Query!
Contact person for scientific queries
Name
96824
0
Dr M-NOUR ALHALABI
Query!
Address
96824
0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Query!
Country
96824
0
Syrian Arab Republic
Query!
Phone
96824
0
+963946459369
Query!
Fax
96824
0
Query!
Email
96824
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5047
Study protocol
[email protected]
5048
Ethical approval
[email protected]
5049
Informed consent form
[email protected]
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.
Download to PDF