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Trial registered on ANZCTR


Registration number
ACTRN12619000440123
Ethics application status
Approved
Date submitted
15/02/2019
Date registered
18/03/2019
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
topical agents used in chemo-mechanical removal of caries.
Scientific title
Evaluation of effectiveness of sodium hypochlorite gel and BRIX 3000 in removing caries of primary molars in children.
Secondary ID [1] 297420 0
none.
Universal Trial Number (UTN)
U1111-1228-6465
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Caries 311591 0
Condition category
Condition code
Oral and Gastrointestinal 310220 310220 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
children included in the trial will be divided into three groups:
Group A: Sodium hypochlorite gel.
Group B: BRIX 3000 gel.
Group C: conventional drilling.

the method of application of chemo-mechanical gels:
teeth will be selected randomly and they should be primary molars which have a cavitated proximal or occlusal caries with no proximity to pulp. The procedure will be performed without anesthesia,
the teeth will be dried, following the principles of Atraumatic Restorative Treatment (ART).
and the gel will be applied by a dentist in an amount of half a grain of rice as mentioned by the manufacturer of BRIX 3000. the application will be with a #2 dentin excavator, leaving it to act for 2 minutes , following the BRIX 3000 manufacturer’s instructions.The infected tissue was then removed through curettage, first at the surrounding walls, using a #2 dentin excavator followed by pulpal wall. the cavity will be washed and dried thorougly. then, caries detector dye will be applied with a microbrush to detect any carious dentin still present.
if any carious tissues will be detected, reapplying of the gel will be considered.

A timer will be switched on at the moment of gel application and it will be switche off whenever all caries will be removed to record time needed to remove caries in minutes.

The whole application will be done by a pedodontist who is available to help researchers and he will monitor the whole procedure.

Immediately after the treatment, the child will be questioned about the discomfort with the performed procedure using the Wong-Baker face scale. The child will be instructed to point to the picture that represents his level of discomfort after the following question:
what did you feel during treatment?

All teeth will be restored with restorations according to the remaining dental structure.
Intervention code [1] 313672 0
Treatment: Drugs
Comparator / control treatment
conventional drilling system using micromotor dentin excavator drills.
Control group
Active

Outcomes
Primary outcome [1] 319103 0
assessment of caries removal.
A blinded investigator will do the measure.
Timepoint [1] 319103 0
Baseline and re-evaluate in one interval stage.
Primary timepoint will be after 2 minutes of application to assess caries removal.
Endpoint will be after the all caries is removed.
Secondary outcome [1] 366981 0
assessment of patient discomfort.
Patient discomfort will be assessed using Wong-Baker Faces scale.
Timepoint [1] 366981 0
Patient discomfort will be assessed using Wong-Baker Faces scale immediately after the intervention.
Secondary outcome [2] 367494 0
time taken to remove the caries.
this will be assessed using a stopwatch.
Timepoint [2] 367494 0
after all caries is removed, the time in minutes taken will be recorded.

Eligibility
Key inclusion criteria
1- cooperative children.
2- inclusion criteria of the teeth involved:
a- primary molars.
b- proximal or occlusal cavitated caries
c- no proximity of caries to pulp.
d- sufficient dental structure to restore the tooth.
Minimum age
4 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who have any allergic reaction to the components of BRIX 3000

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 randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using arandomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2019
Actual
Date of last participant enrolment
Anticipated
10/09/2019
Actual
Date of last data collection
Anticipated
11/09/2019
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 21283 0
Syrian Arab Republic
State/province [1] 21283 0
Damascus

Funding & Sponsors
Funding source category [1] 301988 0
University
Name [1] 301988 0
Damascus University
Country [1] 301988 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 301769 0
None
Name [1] 301769 0
Address [1] 301769 0
Country [1] 301769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302666 0
Ethical and Scientific Committee of dental research of Damascus University
Ethics committee address [1] 302666 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
Ethics committee country [1] 302666 0
Syrian Arab Republic
Date submitted for ethics approval [1] 302666 0
08/01/2019
Approval date [1] 302666 0
12/02/2019
Ethics approval number [1] 302666 0

Summary
Brief summary
Drilling is the most challenging concept in pediatric dentistry, and as modern dentistry represents minimally invasive dentistry. therefore, chemo-mechanical removal of caries is an important way to get rid of all dental caries with preservation of all healthy dental tissues.
chemo-mechanical removal of caries is also a method in behavioral management in children as no anesthesia is needed and no drilling instruments are used.
The null hypothesis tested is that neither sodium hypochlorite gel nor BRIX 3000 is effective in removing caries of primary molars.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90994 0
Dr Muaaz Alkhouli
Address 90994 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
PO Box 30621
Country 90994 0
Syrian Arab Republic
Phone 90994 0
+963966133383
Fax 90994 0
Email 90994 0
[email protected]
Contact person for public queries
Name 90995 0
Awab Midani
Address 90995 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
PO Box 30621
Country 90995 0
Syrian Arab Republic
Phone 90995 0
00963994093794
Fax 90995 0
Email 90995 0
[email protected]
Contact person for scientific queries
Name 90996 0
Muaaz Alkhouli
Address 90996 0
Dental Collage, Damascus University, Al-Mazzeh St, Damascus, Syria
PO Box 30621
Country 90996 0
Syrian Arab Republic
Phone 90996 0
+963966133383
Fax 90996 0
Email 90996 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.