Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001250123
Ethics application status
Approved
Date submitted
10/04/2019
Date registered
10/09/2019
Date last updated
10/09/2019
Date data sharing statement initially provided
10/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between two different technique of applying fissure sealant on permenant molar teeth
Scientific title
Evaluating the pit and fissure sealant retention capabilities of self-etch and conventional acid-etch techniques among school children aged between 8-10 year old: a clinical trial
Secondary ID [1] 297933 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-cavitated teeth 312867 0
fully erupted tooth
 312868 0
Condition category
Condition code
Oral and Gastrointestinal 311365 311365 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
the Rationale of the experiment arm are:
-Finding on the use of (self-etch adhesives) which is the experiment arm is still inconclusive and further clinical trials are needed.
-There is no published clinical study employing a self-etch mode of universal adhesive agent for the placement of fissure sealants.
-With the elimination of the acid etching (rinsing and drying) steps (in the control arm), the need for fewer operative steps and shorter chair time is particularly interesting when treating paediatric patients

In the experiment arm, I will use dental material (not a drug) already in the market globally for more than 5 years (Single Bond Universal Adhesive Scotchbond™) as etching material in a self-etch way but the difference is that I will test the effectiveness of what the producer claims it's effective.
According to manufacturer instruction, the etching material will be raped on the tooth surface for 20 sec then blow with air and use the light cure.

All applications and examinations will be conducted by a single operator which is a dentist.
The self-etching material will be placed on the targeted molar just before the fissure sealant.
According to the pilot study we performed 5min is the estimated time for each tooth.

After curing the sealant will be checked for voids using an explorer.
The occlusion will be checked with articulation paper

The school children will be examined in their school as part of the local preventive program then the potential subject will be given participate sheet and consent form.
Then after that appointments will be arranged to apply the fissure sealant with a different technique in dental faculty um in optimal situations
then participants will be reviewed in 6 and 12 months later

Randomization between techniques will be achieved by computer-generated randomization
Intervention code [1] 314157 0
Prevention
Comparator / control treatment
The golden stander technique in applying fissure sealant will be used as a control arm which known by an acid etch the tooth surface with 37% phosphoric acid for 30 sec. Then wash and dry without saliva contamination after that apply the fissure sealant which is the same in both arms (Clinpro TM Sealant, St Paul, MN, USA)
Control group
Active

Outcomes
Primary outcome [1] 319710 0
Primary outcome: Retention capability of fissure sealant

Evaluation criteria:
Using visual inspection to evaluate the sealants as described by Feigal RJ et al. (2000):
A) complete retention (all pits and fissures covered by the sealant)
B) partial loss (one or more fissures not covered by the sealant)
B1, without caries; B2, with caries
C) complete loss (all pits and fissures uncovered)
C1, without caries; C2, with caries

All follow up will be carried out by a single dentist.

There is no complications or possible adverse effects that may happen to your child
Timepoint [1] 319710 0
6,9 and 12 months post-fissure sealant application.
6 months after fissure sealant applications is the primary timepoint.
Secondary outcome [1] 369257 0
nill
Timepoint [1] 369257 0
nill

Eligibility
Key inclusion criteria
1. Children aged 8 to 10 years old
2. Sound and non-cavitated (ICDAS oA )occlusal surfaces of the first permanent molar
3. Fully erupted first permanent molars
4. Gained consent from each subject
5. Cooperative children
Minimum age
8 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Children below 8 years old and above 10 years old
2. Children with cavitated, previously placed restorations or sealants on their first permanent molars
3. No consent for treatment
4. Uncooperative children
5. Patients with parafunctional habits
6. Mentally challenged or physically handicapped

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
spilt mouth design
It is a popular design in oral health research, each of the two treatments (experiment and control) are randomly assigned to either the right or left halves of the dentition. So by this design, we can reduce the variables between the two groups.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
30/11/2019
Actual
Date of last data collection
Anticipated
30/11/2020
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 21395 0
Malaysia
State/province [1] 21395 0
KUALA LUMPUR

Funding & Sponsors
Funding source category [1] 302450 0
University
Name [1] 302450 0
university of Malaya
Country [1] 302450 0
Malaysia
Primary sponsor type
Individual
Name
yazeed magbul althomali
Address
Depart. of paediatric dentistry & Orthodontics
faculty of dentistry, University of Malaya, 50603 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 302350 0
Individual
Name [1] 302350 0
prof. Dr. sabri mousa
Address [1] 302350 0
Depart. of paediatric dentistry & Orthodontics
faculty of dentistry, University of Malaya, 50603 Kuala Lumpur
Country [1] 302350 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303117 0
Medical Ethics Committee faculty of dentistry University of Malaya
Ethics committee address [1] 303117 0
Faculty of Dentistry, University of Malaya, 50603 Kuala Lumpur
Ethics committee country [1] 303117 0
Malaysia
Date submitted for ethics approval [1] 303117 0
Approval date [1] 303117 0
03/08/2018
Ethics approval number [1] 303117 0

Summary
Brief summary
In the intervention group, I will use dental material (not a drug) already in the market globally for more than 5 years (Single Bond Universal Adhesive Scotchbond™) but the difference is that I will test the effectiveness of what the producer claims it's effective.

Study purpose
This study is important to determine the superiority of retention clinically between the two techniques of sealant applications.

Hypothesis
There is a difference in sealant retention after the application of the self-etch (intervention) or the traditional acid-etch(control) techniques.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92538 0
Dr Yazeed Magbul althomali
Address 92538 0
Depart. of Paediatric Dentistry & Orthodontics
Faculty of Dentistry, University of Malaya, 50603 Kuala Lumpur
Country 92538 0
Malaysia
Phone 92538 0
+60145231990
Fax 92538 0
Email 92538 0
[email protected]
Contact person for public queries
Name 92539 0
Dr Yazeed Magbul althomali
Address 92539 0
Depart. of Paediatric Dentistry & Orthodontics
Faculty of Dentistry, University of Malaya, 50603 Kuala Lumpur
Country 92539 0
Malaysia
Phone 92539 0
+60145231990
Fax 92539 0
Email 92539 0
[email protected]
Contact person for scientific queries
Name 92540 0
Dr Yazeed Magbul althomali
Address 92540 0
Depart. of Paediatric Dentistry & Orthodontics
Faculty of Dentistry, University of Malaya, 50603 Kuala Lumpur
Country 92540 0
Malaysia
Phone 92540 0
+60145231990
Fax 92540 0
Email 92540 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
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3867Basic resultsNo 377370-(Uploaded-19-05-2021-12-37-08)-Basic results summary.docx

Documents added automatically
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