Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date results information initially provided
7/09/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Bioactive glass to prevent post-operative sensitivity of vital teeth bleaching
Query!
Scientific title
Effect of Bioactive glass on efficacy and post-operative sensitivity of vital teeth bleaching:
Randomized Controlled Clinical Trial
Query!
Secondary ID [1]
301822
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1263-2906
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Teeth sensitivity
318301
0
Query!
Teeth color changes after bleaching
320164
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
316313
316313
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
318122
0
Treatment: Other
Query!
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
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
324485
0
Tooth sensitivity using visual analogue scale.
Query!
Assessment method [1]
324485
0
Query!
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."
Query!
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
Query!
Assessment method [1]
384787
0
Query!
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
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
30
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/01/2022
Query!
Actual
1/11/2021
Query!
Date of last participant enrolment
Anticipated
1/03/2022
Query!
Actual
31/12/2021
Query!
Date of last data collection
Anticipated
30/09/2022
Query!
Actual
30/06/2022
Query!
Sample size
Target
24
Query!
Accrual to date
Query!
Final
24
Query!
Recruitment outside Australia
Country [1]
22773
0
Syrian Arab Republic
Query!
State/province [1]
22773
0
Damascus
Query!
Funding & Sponsors
Funding source category [1]
306250
0
University
Query!
Name [1]
306250
0
Damascus University
Query!
Address [1]
306250
0
Mazzah highway,Damascus,Syria
Query!
Country [1]
306250
0
Syrian Arab Republic
Query!
Primary sponsor type
University
Query!
Name
Damascus University
Query!
Address
Mazzah highway,Damascus,Syria
Query!
Country
Syrian Arab Republic
Query!
Secondary sponsor category [1]
308167
0
None
Query!
Name [1]
308167
0
Query!
Address [1]
308167
0
Query!
Country [1]
308167
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
306459
0
Ethical and scientific committee of dental research of Damascus University
Query!
Ethics committee address [1]
306459
0
Mazzah highway,Damascus,Syria
Query!
Ethics committee country [1]
306459
0
Syrian Arab Republic
Query!
Date submitted for ethics approval [1]
306459
0
16/06/2020
Query!
Approval date [1]
306459
0
06/07/2020
Query!
Ethics approval number [1]
306459
0
Query!
Summary
Brief summary
A randomised double-blind placebo-controlled clinical trial aimed to evaluate the effect of bioactive glass 45S5 (BAG) on color change and tooth sensitivity (TS) associated with at-home vital tooth bleaching using 20% carbamide peroxide (CP).
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
103958
0
Dr MHD YAZAN AL BIZREH
Query!
Address
103958
0
Damascus University.
Muhajireen neighborhood, Shatta street, first avenue near Royal Bread, Damascus, Syria.
Query!
Country
103958
0
Syrian Arab Republic
Query!
Phone
103958
0
+963957225696
Query!
Fax
103958
0
Query!
Email
103958
0
[email protected]
Query!
Contact person for public queries
Name
103959
0
Dr MHD YAZAN AL BIZREH
Query!
Address
103959
0
Damascus University.
Muhajireen neighborhood, Shatta street, first avenue near Royal Bread, Damascus, Syria.
Query!
Country
103959
0
Syrian Arab Republic
Query!
Phone
103959
0
+963957225696
Query!
Fax
103959
0
Query!
Email
103959
0
[email protected]
Query!
Contact person for scientific queries
Name
103960
0
Dr MHD YAZAN AL BIZREH
Query!
Address
103960
0
Damascus University.
Muhajireen neighborhood, Shatta street, first avenue near Royal Bread, Damascus, Syria.
Query!
Country
103960
0
Syrian Arab Republic
Query!
Phone
103960
0
+963957225696
Query!
Fax
103960
0
Query!
Email
103960
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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
Source
Title
Year of Publication
DOI
Embase
Effect of bioactive glass paste on efficacy and post-operative sensitivity associated with at-home bleaching using 20% carbamide peroxide: a randomized controlled clinical trial.
2022
https://dx.doi.org/10.1186/s40001-022-00826-5
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF