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Trial registered on ANZCTR


Registration number
ACTRN12618001940268
Ethics application status
Approved
Date submitted
22/11/2018
Date registered
29/11/2018
Date last updated
13/11/2019
Date data sharing statement initially provided
29/11/2018
Date results provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Moisture tolerant sealants to arrest incipient caries in newly erupted molars
Scientific title
Retention and Remineralization effect of moisture tolerant resin-based sealant and glass ionomer sealant on non-Cavitated Incipient Pit and Fissure Caries
Secondary ID [1] 296682 0
none
Universal Trial Number (UTN)
U1111-1224-4300
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries
 310530 0
Condition category
Condition code
Oral and Gastrointestinal 309241 309241 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
An experienced investigator will screen all possible candidates for inclusion and exclusion criteria. Patients that meet inclusion criteria will be seated on a dental unit and bite wing radiographs will be taken to rule out proximal caries. Then a thorough oral prophylaxis will be conducted using a bristle brush and pumice paste.

Occlusal surfaces of mandibular first permanent molars will be assessed by a visual and tactile method and scored according to International Caries Detection and Assessment System (ICDAS) criteria. If one of the teeth failed to score 1, or 2, the patient will be excluded.

After that, Teeth will be diagnosed using DIAGNOdent device (Kavo, Germany). Measurements will be done after drying the teeth with air flow and isolating them by cotton rolls. First of all, calibration with a ceramic standard will be done, then baseline values for each tooth will be recorded by measuring the sound buccal surface of the examined teeth then moving upward toward the occlusal surface. After probing the whole occlusal surface, the procedure will be repeated three times. At the end, the peak value will be recorded as the baseline value for this tooth. If one of the teeth failed to get a score between 14-30, the patient will be excluded.

No treatment will be provided in the first visit. A standard oral-hygiene training will be provided to the children. They will be asked to brush their teeth in the instructed way two times a day.

One week later, selected participants will draw from two opaque envelopes. The first draw will be to determine on which side the treatment will take apart first (Right or left). The Second draw will be to determine which type of the sealant will be applied on the selected side (group A or group B).So at the end each participant will be applied the two materials

Before the application of pit and fissure sealants, another oral prophylaxis will be conducted then tooth surface will be rinsed with water. After that, isolation of the tooth will be done using cotton rolls and saliva ejector.

In group A, teeth will be sealed with Embrace WetBond Sealant (Pulpdent Corporation, Watertown, Mass., USA) following the manufacturer’s instructions. The occlusal surface will be dried using compressed air, followed by acid etching with 37 percent phosphoric acid gel for 20 seconds (Total Etch, Ivoclar Vivadent, Schaan, Liechtenstein). Then, tooth will be rinsed with water for approximately 30 seconds. Excess moisture will be removed from the tooth surface using cotton pellets, but the tooth will still be slightly moist, glossy, or shiny. Embrace WetBond sealant will be applied to the pits and fissures with a small applicator tip attached to the syringe. The sealant will be light cured for 20 seconds using a visible light cure unit.A very little amount of capsule will be used to fill the fissures and pits without extensive material which can just cover the fissures is 0.04 ml

In group B, teeth will be sealed with Fuji Triage (GC, Tokyo, Japan) following the manufacturer’s instructions. The occlusal surface will be dried using compressed air, followed by applying Cavity conditioner (GC, Tokyo, Japan) for approximately 15 seconds. Then, tooth will be rinsed with water for approximately 15 seconds. Tooth surface will be blot dried by air flow and cotton pellets. Fuji Triage capsule will be mixed by an amalgamator for 10 seconds. Then the capsule will be inserted into the GC capsule applicator (GC, Tokyo, Japan) and will be triggered and applied to pits and fissures on the selected tooth surface. After 2 and a half minutes (setting time for Fuji triage), petroleum gel will be wiped on the sealant surface.
A few drops will be used to fill the fissures and pits without extensive material which can just cover the fissures is approximately 0.04 ml

Both interventions will be done by an experienced investigator.

The follow up recalls will be conducted after 3 and 6 months for all participants. Retention and remineralization effect of the applied sealants will be evaluated by two calibrated investigators.
Each sealant will be examined for retention at 3 and 6 months follow up recalls using a dental explorer
At the second recall and after retention evaluation, sealants will be removed using an air abrasion device (Rondoflex-plus 360 Kavo®, Biberach, Germany).

After that, Remineralization assessment will be conducted using DIAGNOdent device using the same technique that was used at baseline measurements.
Intervention code [1] 312996 0
Treatment: Drugs
Comparator / control treatment
Fuji Triage ( Gic sealants)
Control group
Active

Outcomes
Primary outcome [1] 308209 0
Retention

The measure will be done by an experienced investigator using a dental explorer following the criteria score:
0 = sealant completely retained; 1 = sealant partially lost or 2 = sealant completely lost. (Oulis and Berdouses criteria)
Timepoint [1] 308209 0
Each sealant will be examined for retention at two interval points:

T1 : 3 months
T2 : 6 months
Primary outcome [2] 308212 0
Remineralization effect

Remineralization assessment will be conducted using DIAGNOdent device by an experienced investigator
Timepoint [2] 308212 0
after 6 months of placing the sealants
Secondary outcome [1] 354440 0
NIL
Timepoint [1] 354440 0
NIL

Eligibility
Key inclusion criteria
Patient related criteria:
1) Cooperative Children aged from 6 to 9
2) Healthy patients with no history of previous systematic diseases that can affect their oral health
Teeth related criteria:
1) Both mandibular-symmetric first permanent molars are fully erupted
2) First permanent molars’ occlusal surfaces show scores of 1, or 2 according to the International Caries Detection and Assessment System II (ICDAS II) and show scores between 14 – 30 by using DIAGNOdent device(table 2).
Minimum age
6 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
uncooperative children, children with mental and/or physical disorders; teeth suffer from proximal caries, developmental defects, cavitation, hypoplasia and teeth with sealant or restoration.
surfaces show score 3 or more according to the International Caries Detection and Assessment System II (ICDAS II) and show score more than 30 by using DIAGNOdent device

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
selected participants will draw from two opaque envelopes. The first draw will be to determine on which side the treatment will take apart first (Right or left). The Second draw will be to determine which type of the sealant will be applied on the selected side (group A or group B).
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
Crossover
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 two-sample t-test, it was estimated that 68 teeth/34 participants were required to demonstrate an effect size (0.4) in the average proportion of remineralized incipient pit and fissure caries.
Sample size will be raised to 80 teeth/40 patients to avoid the negative effect of the possible drop rate.

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, student's t-test will be applied.
- if the data were not normally distributed, Mann Whiteny-U test will be applied.
- The level of significance will be set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/11/2018
Actual
2/12/2018
Date of last participant enrolment
Anticipated
12/12/2018
Actual
4/12/2018
Date of last data collection
Anticipated
12/06/2019
Actual
19/06/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 21058 0
Syrian Arab Republic
State/province [1] 21058 0
Damscus

Funding & Sponsors
Funding source category [1] 301261 0
University
Name [1] 301261 0
Damascus University
Country [1] 301261 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
Country
Syrian Arab Republic
Secondary sponsor category [1] 300901 0
None
Name [1] 300901 0
none
Address [1] 300901 0
none
Country [1] 300901 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302004 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 302004 0
Ethics committee country [1] 302004 0
Syrian Arab Republic
Date submitted for ethics approval [1] 302004 0
Approval date [1] 302004 0
20/07/2018
Ethics approval number [1] 302004 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88822 0
Dr Laith ALSABEK
Address 88822 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 88822 0
Syrian Arab Republic
Phone 88822 0
+963937178467
Fax 88822 0
Email 88822 0
alsabeklaith@gmail.com
Contact person for public queries
Name 88823 0
Laith ALSABEK
Address 88823 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 88823 0
Syrian Arab Republic
Phone 88823 0
+963937178467
Fax 88823 0
Email 88823 0
alsabeklaith@gmail.com
Contact person for scientific queries
Name 88824 0
Laith ALSABEK
Address 88824 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 88824 0
Syrian Arab Republic
Phone 88824 0
+963937178467
Fax 88824 0
Email 88824 0
alsabeklaith@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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5665Study protocol    376441-(Uploaded-05-11-2019-17-31-24)-Study-related document.docx



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.