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Trial registered on ANZCTR


Registration number
ACTRN12621001600831
Ethics application status
Approved
Date submitted
25/04/2021
Date registered
23/11/2021
Date last updated
23/11/2021
Date data sharing statement initially provided
23/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison Study of Effectiveness of High Viscosity Bulk Fill Composite Resin and Compomer on The Second Lower Primary Molars In Children.
Scientific title
Comparison Study of Effectiveness of High Viscosity Bulk Fill Composite Resin and Compomer in comparison to Incremental Technique Composite Resin Applied to the Second Lower Primary Molars in Children 5 to 9 years old as reflected in the percentages recurent caries and sensitivity to air blowing.
Secondary ID [1] 301160 0
None
Universal Trial Number (UTN)
U1111-1250-5901
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric dental caries. 317484 0
Condition category
Condition code
Oral and Gastrointestinal 315585 315585 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
All cases diagnosed with primary lower 2nd molars class 2 caries will undergo inferior alveolar nerve block as regional anesthesia using topical benzocaine gel 20% and 2% lidocaine with 1/80000 adrenaline (Septodent) injected through 25 mm gauge 27 disposable needle (NEDTC). A rubber dam will be applied and mesial or distal class II cavity preparation will be performed followed by application of metal cervical matrix band with wooden wedges. Then total etching using 39% phosphoric acid and Futurabond™, (VOCO) is applied. The preparations will be distributed in a randomized way to be filled with one of the following materials: Dental bulk fill composite X-tra fill™, (VOCO)(Intervention arm 1) , Polyacid-modified resin composite Glasiosite Compomer™, (VOCO)(Intervention arm 2), and a resin composite applied by incremental technique Polofil Supra™, (VOCO)(Control arm). These preparations will be performed using a turbine handpiece (NSK) and diamond round and cutting burs in addition to composite finishing burs. The procedure lasts for 30 minutes in average.
As all the procedures for all recruited cases are performed by single dentist (the principal investigator) who perform all three kinds of procedures with adherence to protocol proposed by himself. Also, photos are available for most cases in different stages of procedures.
The children will be followed up 3, 6, and 12 months later for outcome evaluation.
Clinical evaluation, procedures and follow up visits will be done in pediatric dentistry department in Damascus University on outpatient basis by a different dentist who is pediatric dentistry undergraduate with 3 years pediatric dentistry experience.
Intervention code [1] 317622 0
Treatment: Surgery
Comparator / control treatment
The group of preparations filled with resin composite applied by incremental technique Polofil Supra™, (VOCO).
Control group
Active

Outcomes
Primary outcome [1] 324307 0
Percentage of secondary (recurrent) caries according to the USPHS (United States Public Health Criteria)
Timepoint [1] 324307 0
(T0): baseline on the same day of restoration and re-evaluate three times interval stages:
(T1): three months after restoration (primary timepoint).
(T2): six months after restoration.
(T3): twelve months after restoration.
Primary outcome [2] 324308 0
Percentage of postoperative sensitivity by air blowing according to the USPHS (United States Public Health Criteria),
Timepoint [2] 324308 0
(T0): baseline on the same day of restoratio and re-evaluate three times interval stages:
(T1): three months after restoration (primary timepoint).
(T2): six months after restoration.
(T3): twelve months after restoration.
Primary outcome [3] 324309 0
Restoration fracture as defined according to the USPHS (United States Public Health Criteria),
Timepoint [3] 324309 0
(T0): baseline on the same day of restoration and re-evaluate three times interval stages:
(T1): three months after restoration(primary timepoint).
(T2): six months after restoration.
(T3): twelve months after restoration.
Secondary outcome [1] 384282 0
Postoperative erosion as defined according to the USPHS (United States Public Health Criteria),
Timepoint [1] 384282 0
(T0): baseline and re-evaluate three times interval stages:
(T1): three months after restoration.
(T2): six months after restoration.
(T3): twelve months after restoration.

Eligibility
Key inclusion criteria
Caries of lower second primary molar in children with behavior rated as definitely positive (Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation) or positive (Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively) according to Frankl behavioral Scale modified by Salviov- Tinawi aged 5 to 9 years.
Minimum age
5 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Associated medical comorbidities or mental disabilities.
Bad oral health situation.
Presence of acute symptoms like pain or abscess formation.
Rejection of recruitment by family or guardian.

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)
Number are allocated to the expected recruited cases from the beginning. These number are randomly allocated to three groups. When the case is recruited it will be previously allocated to one of the groups with no intervention awareness by the investigator who recruited it.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by www.graphpad.com.
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
Sample size was calculated using g-power 3.1 software. The significance level set at 0.05 and the power of the study at 0.80.
Based on a one-way Anova test, it is estimated that 60 patients needed to demonstrate an effective size.
SPSS statistical software for Windows will be used for statistical analysis.
Kruskal Wallis test will be applied. Deviations from the baseline will be tested for significance with the Wilcoxon Signed Rank Matched Paris Test.
Interrater reliability will be tested using Cohen 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
9/02/2020
Date of last participant enrolment
Anticipated
Actual
16/06/2021
Date of last data collection
Anticipated
16/06/2022
Actual
Sample size
Target
60
Accrual to date
Final
55
Recruitment outside Australia
Country [1] 22819 0
Syrian Arab Republic
State/province [1] 22819 0
Damascus

Funding & Sponsors
Funding source category [1] 305603 0
University
Name [1] 305603 0
Damascus University, Faculty of Dentistry.
Country [1] 305603 0
Syrian Arab Republic
Primary sponsor type
Individual
Name
Prof. Mohamed Al Tinawi
Address
Meza Highway, KafrSusehDamascus University, Faculty of Dentistry.
Country
Syrian Arab Republic
Secondary sponsor category [1] 306017 0
University
Name [1] 306017 0
Damascus University, Faculty of Dentistry
Address [1] 306017 0
Meza Highway, Kafr Suseh area, Damascus
Country [1] 306017 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305901 0
Damascus University Council of Postgraduate Studies and Research
Ethics committee address [1] 305901 0
Mousalam Baroudy St, Al Baramkeh, Damascus, Syria.
Ethics committee country [1] 305901 0
Syrian Arab Republic
Date submitted for ethics approval [1] 305901 0
Approval date [1] 305901 0
24/06/2019
Ethics approval number [1] 305901 0
3365

Summary
Brief summary
A randomized controlled trial comparing clinical performance and outcome of bulk fill composite against compomer applied to class II restoration of 2nd lower primary molars in children aged 5 to 9 years. The comparison is based on recurrence of decay and sensitivity to air blowing
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101994 0
Dr Maram Al Saitry
Address 101994 0
Damascus University, Faculty of Dentistry, Pediatric Dentistry Department, Meza Highway, Kafr Suseh area, Damascus.
Country 101994 0
Syrian Arab Republic
Phone 101994 0
+963112119809
Fax 101994 0
Email 101994 0
[email protected]
Contact person for public queries
Name 101995 0
Maram Al Saitry
Address 101995 0
Damascus University, Faculty of Dentistry, Pediatric Dentistry Department, Meza Highway, Kafr Suseh area, Damascus.
Country 101995 0
Syrian Arab Republic
Phone 101995 0
+963112119809
Fax 101995 0
Email 101995 0
[email protected]
Contact person for scientific queries
Name 101996 0
Maram Al Saitry
Address 101996 0
Damascus University, Faculty of Dentistry, Pediatric Dentistry Department, Meza Highway, Kafr Sudeh. Damascus.
Country 101996 0
Syrian Arab Republic
Phone 101996 0
+963112119809
Fax 101996 0
Email 101996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age, gender, involved teeth, general medical condition, class of caries, treatment outcome.
When will data be available (start and end dates)?
01/01/2022 to 31/12/2024
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8474Study protocolThrough the Principal investigator. https://drive.google.com/file/d/1gWJpWYAa_cnH40AyGNRmI_soWXwAIcKV/view?usp=sharing[email protected] The study protocol is available in Arabic and it w... [More Details] 379734-(Uploaded-11-07-2020-13-39-05)-Study-related document.pdf
12899Informed consent form https://drive.google.com/file/d/1gWJpWYAa_cnH40AyGNRmI_soWXwAIcKV/view?usp=sharing[email protected] The informed consent is included in the above file... [More Details]



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.