Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000794303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
13/12/2025
Date registered
Help: Date registered
2/07/2026
Date last updated
Help: Date last updated
9/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
2/07/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of BioMin F on tooth sensitivity after in-office bleaching.
Scientific title
Effect of bioactive glass on efficacy and postoperative sensitivity associated with in-Office tooth bleaching using 35% hydrogen peroxide: a randomized controlled clinical trial in healthy adults aged 18 to 40 years.
Additional trial identifiers [1] 316170 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Teeth discoloration 340144 0
Condition category
Condition code
Oral and Gastrointestinal 336339 336339 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
All participants will undergo professional cleaning of the study teeth prior to whitening. The tooth surfaces will be cleaned using a non-abrasive, fluoride-free whitening powder and a brush attached to a microbrush to remove plaque and surface deposits.

Participants in the intervention group will use BioMin F toothpaste, and participants in the control group will use a placebo paste, applied into customised trays at home. A thin, even layer of the assigned paste will be placed inside the tray in an amount sufficient to cover the study teeth without overflow. The tray will be worn once daily for 30 minutes for one week before the first in-office whitening session.

Following this pre-treatment period, in-office whitening will be performed using 35% hydrogen peroxide gel applied to the study teeth (from the right first premolar to the left first premolar) for 40 minutes. Before application of the whitening gel, gingival isolation will be performed using a gingival barrier gel. All in-office whitening procedures will be performed by the treating dentist in the clinical setting.

There will be two in-office whitening sessions separated by one week. After the first whitening session, the assigned paste (BioMin F or placebo) will be reapplied using the customised tray once daily for 30 minutes for another week, i.e. during the interval between the two whitening sessions.

The tray-based paste application will be self-administered by the participants at home. Adherence will be monitored by asking participants to submit photographs showing the material placed inside the tray and the tray in situ during use. These photographs will be reviewed by the research team to confirm compliance with the study protocol.
Intervention code [1] 332787 0
Treatment: Other
Description of the comparator or control
Participants in the control group will receive a placebo paste prepared by the Faculty of Pharmacy, Damascus University. The placebo is a fluoride-containing toothpaste without bioactive glass or desensitizing agents. It will be self-administered by participants at home using a customised tray. A thin, even layer of the paste will be placed inside the tray in an amount sufficient to cover the study teeth without overflow. The tray will be worn once daily for 30 minutes for one week before the first in-office whitening session and for one week after the first whitening session.

Participants in the control group will undergo the same in-office whitening protocol as the intervention group. Before whitening, the study teeth will be cleaned using a non-abrasive, fluoride-free whitening powder and a brush attached to a microbrush to remove plaque and surface deposits. Whitening will then be performed by the treating dentist in the clinical setting using 35% hydrogen peroxide gel applied to the study teeth for 40 minutes following gingival isolation with a gingival barrier gel. There will be two in-office whitening sessions separated by one week.

Adherence to the placebo application will be monitored through participant-submitted photographs showing the material placed inside the tray and the tray in situ during use. These photographs will be reviewed by the research team to confirm compliance with the study protocol.
Control group
Placebo

Outcomes
Primary outcome [1] 343852 0
Color change using digital spectrophotometer
Timepoint [1] 343852 0
Primary outcomes will be assessed at the following timepoints: Baseline (before first bleaching session), 1 week post-first bleaching (before second session), 1 week post-second bleaching session (primary timepoint), 4 weeks post-second bleaching, 3 months post-baseline, and 6 months post-baseline.
Primary outcome [2] 343853 0
Color change using color shade guide.
Timepoint [2] 343853 0
Primary outcomes will be assessed at the following timepoints: Baseline (before first bleaching session), 1 week post-first bleaching (before second session), 1 week post-second bleaching session (primary timepoint), 4 weeks post-second bleaching, 3 months post-baseline, and 6 months post-baseline.
Secondary outcome [1] 455873 0
Teeth sensitivity using visual analog scale
Timepoint [1] 455873 0
Tooth sensitivity will be assessed at the following timepoints relative to the bleaching intervention: Before the first bleaching session (baseline). 2 hours after the first bleaching session. 1 day after the first bleaching session. 2 days after the first bleaching session. 2 hours after the second bleaching session 1 day after the second bleaching session 2 days after the second bleaching session 1 month post-baseline (1 month after the second bleaching session) 3 months post-baseline (3 months after the second bleaching session).

Eligibility
Key inclusion criteria

1.The patient's age must be at least 18 years.

2.Six upper anterior teeth free of caries or restorations on the buccal surfaces.

3.The tooth color should not be less than A2 on the Classical scale in the Compact Vita 3 shade guide.

4.No dental sensitivity or use of anti-sensitivity materials or toothpastes for sensitive teeth in the last three months.

5.The patient should be in good overall health.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria

1.The patient has not undergone any previous teeth whitening procedures.

2.A history of chronic therapeutic drug use.

3.The presence of orthodontic devices.

4.Periodontal diseases or active carious lesions.

5.Pregnancy or breastfeeding.

6.Severe intrinsic tooth discoloration.

7.Sensitivity to whitening materials.

8.Smoking.

9.Patients with oral manifestations that may cause sensitivity (such as recession, fissures, or exposed dentin).

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)
Allocation will be done using sealed opaque envelopes
Inside each envelope, there is the code of the group that the participant will be in
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
9/09/2025
Date of last participant enrolment
Anticipated
Actual
25/04/2026
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
34
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 27686 0
Syrian Arab Republic
State/province [1] 27686 0
Country [2] 27687 0
Syrian Arab Republic
State/province [2] 27687 0

Funding & Sponsors
Funding source category [1] 320768 0
University
Name [1] 320768 0
Damascus university
Country [1] 320768 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus university
Address
Country
Syrian Arab Republic
Secondary sponsor category [1] 324204 0
None
Name [1] 324204 0
None
Address [1] 324204 0
Country [1] 324204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319298 0
Ethical and scientific committee of dental research of Damascus University
Ethics committee address [1] 319298 0
Ethics committee country [1] 319298 0
Syrian Arab Republic
Date submitted for ethics approval [1] 319298 0
08/08/2025
Approval date [1] 319298 0
17/05/2026
Ethics approval number [1] 319298 0

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

Contacts
Principal investigator
Name 146906 0
Dr Musab Al-Khayyat Afadar
Address 146906 0
Faculty of Dentistry, University of Damascus, Mazzah Highway, Fayez Mansour Street, Damascus, Syria
Country 146906 0
Syrian Arab Republic
Phone 146906 0
+963933357636
Fax 146906 0
Email 146906 0
[email protected]
Contact person for public queries
Name 146907 0
Musab Al-Khayyat Afadar
Address 146907 0
Faculty of Dentistry, University of Damascus, Mazzah Highway, Fayez Mansour Street, Damascus, Syria
Country 146907 0
Syrian Arab Republic
Phone 146907 0
+963933357636
Fax 146907 0
Email 146907 0
[email protected]
Contact person for scientific queries
Name 146908 0
Musab Al-Khayyat Afadar
Address 146908 0
Faculty of Dentistry, University of Damascus, Mazzah Highway, Fayez Mansour Street, Damascus, Syria
Country 146908 0
Syrian Arab Republic
Phone 146908 0
+963933357636
Fax 146908 0
Email 146908 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.