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Trial registered on ANZCTR


Registration number
ACTRN12621001334897
Ethics application status
Approved
Date submitted
30/12/2020
Date registered
5/10/2021
Date last updated
7/09/2022
Date data sharing statement initially provided
5/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Bioactive glass to prevent post-operative sensitivity of vital teeth bleaching
Scientific title
Effect of Bioactive glass on efficacy and post-operative sensitivity of vital teeth bleaching:
Randomized Controlled Clinical Trial
Secondary ID [1] 301822 0
Nil known
Universal Trial Number (UTN)
U1111-1263-2906
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Teeth sensitivity 318301 0
Teeth color changes after bleaching 320164 0
Condition category
Condition code
Oral and Gastrointestinal 316313 316313 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 participants will be instructed to apply 20% carbamide peroxide bleaching agent (7 days—04 h each) (Opalescence® PF™, Ultradent Products Inc. USA—20% carbamide peroxide) , delivered by the bleaching custom tray.
followed by the application of tooth paste containing Bioactive glass 45S5 (Sensodyne Repair & Protect contains NovaMin® technology) delivered by the bleaching custom tray (7 days—30 min each).
The bleaching agent and 45S5 toothpaste will be delivered individually by the participants themselves at their home by the bleaching custom tray.
For monitor adherence to the intervention , the researcher will check the bleaching agent and toothpaste containers after 7 days of commencement of intervention to make sure that they are empty.
Intervention code [1] 318122 0
Treatment: Other
Comparator / control treatment
The participants in control group will be instructed to apply 20% carbamide peroxide bleaching agent (7 days—04 h each) delivered by the bleaching custom tray, followed by the application of non-active placebo paste, delivered by the bleaching custom tray (7 days—30 min each).
Both of the studied agents (placebo and Novamin) will have the same color and texture. in addition, they will be delivered to the patients by the same containers. this will be occurred in order to cover the blinding method of the study.

The composition of 500 g of the placebo tooth paste as follows:
Calcium Carbonate (Abrasive) 30% × 500 = 150 g
Sodium Lauryl Sulfate (Foaming Detergent) 2% × 500 = 10 g
Menthol oily (Cooling refreshing flavor) 1.2% × 500 = 6 g
Purified Water (Solvent) 30% × 500 = 150 g
Sodium Saccharin (Artificial Sweetener) 4% × 500 = 20 g
Cocaimdopropyl betaine (Foam booster – Thickener( 1% × 500 = 5 g
Sodium methyl cocoyl taurate (Foam booster – Thickener( 1% × 500 = 5 g
Glycerin (Humectant – Sweetener) 30% × 500 = 150 g
Carbopol (Thickener) 0.8% × 500 = 4g
Control group
Placebo

Outcomes
Primary outcome [1] 324485 0
Tooth sensitivity using visual analogue scale.
Timepoint [1] 324485 0
Follow-up will be daily for 7 days after application of both the bleaching agent and the Bioactive/placebo toothpaste. The primary outcome will be assessed by the patients themselves using visual analogue scale in the first day of commencement of intervention."
Secondary outcome [1] 384787 0
Color changes using digital spectrophotometer.
The digital spectrophotometer measures the shade of teeth based on the CIE L*a*b* color space system, allowing the determination of color in a three dimensional space
Timepoint [1] 384787 0
Baseline: before the beginning of the intervention.
Follow-up will be after 3 days , 1 week ,15 days, 1 month, 3 months and 6 months after intervention commencement of both the bleaching agent and the Bioactive/placebo toothpaste

Eligibility
Key inclusion criteria
1-be at least 18 years old,
2-Have six maxillary anterior teeth with no restorations or carious lesions on their buccal surfaces,
3-colour shade B2 or darker on the shade guide (Vitapan Classical, Vita
Zahnfabrik)
4-No history of tooth sensitivity or use of a desensitising agent or desensitising toothpaste in the past 3 months.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1-Previous tooth-bleaching procedures,
2-chronic therapeutic drug history,
3-orthodontic appliance use,
4-periodontal disease or active carious lesions,
5-pregnancy or lactation,
6- severe internal tooth discolouration,
7-allergies to bleaching agent or tray material,
8-smoking.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2022
Actual
1/11/2021
Date of last participant enrolment
Anticipated
1/03/2022
Actual
31/12/2021
Date of last data collection
Anticipated
30/09/2022
Actual
30/06/2022
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 22773 0
Syrian Arab Republic
State/province [1] 22773 0
Damascus

Funding & Sponsors
Funding source category [1] 306250 0
University
Name [1] 306250 0
Damascus University
Country [1] 306250 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Mazzah highway,Damascus,Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 308167 0
None
Name [1] 308167 0
Address [1] 308167 0
Country [1] 308167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306459 0
Ethical and scientific committee of dental research of Damascus University
Ethics committee address [1] 306459 0
Ethics committee country [1] 306459 0
Syrian Arab Republic
Date submitted for ethics approval [1] 306459 0
16/06/2020
Approval date [1] 306459 0
06/07/2020
Ethics approval number [1] 306459 0

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

Contacts
Principal investigator
Name 103958 0
Dr MHD YAZAN AL BIZREH
Address 103958 0
Damascus University.
Muhajireen neighborhood, Shatta street, first avenue near Royal Bread, Damascus, Syria.
Country 103958 0
Syrian Arab Republic
Phone 103958 0
+963957225696
Fax 103958 0
Email 103958 0
[email protected]
Contact person for public queries
Name 103959 0
MHD YAZAN AL BIZREH
Address 103959 0
Damascus University.
Muhajireen neighborhood, Shatta street, first avenue near Royal Bread, Damascus, Syria.
Country 103959 0
Syrian Arab Republic
Phone 103959 0
+963957225696
Fax 103959 0
Email 103959 0
[email protected]
Contact person for scientific queries
Name 103960 0
MHD YAZAN AL BIZREH
Address 103960 0
Damascus University.
Muhajireen neighborhood, Shatta street, first avenue near Royal Bread, Damascus, Syria.
Country 103960 0
Syrian Arab Republic
Phone 103960 0
+963957225696
Fax 103960 0
Email 103960 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
SourceTitleYear of PublicationDOI
EmbaseEffect of bioactive glass paste on efficacy and post-operative sensitivity associated with at-home bleaching using 20% carbamide peroxide: a randomized controlled clinical trial.2022https://dx.doi.org/10.1186/s40001-022-00826-5
N.B. These documents automatically identified may not have been verified by the study sponsor.