Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000553673
Ethics application status
Approved
Date submitted
13/02/2023
Date registered
24/05/2023
Date last updated
24/05/2023
Date data sharing statement initially provided
24/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical study to evaluate the effect of Phthalimidoperoxycaproic Acid (PAP) on Vital Teeth Bleaching
Scientific title
Evaluating the Efficacy of Phthalimidoperoxycaproic Acid (PAP) on Vital Teeth Bleaching and Post-Operative Sensitivity: a randomized controlled clinical trial
Secondary ID [1] 308877 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Teeth Discoloration 328861 0
Condition category
Condition code
Oral and Gastrointestinal 325859 325859 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
Vital teeth bleaching using Phthalimidoperoxycaproic acid.
The participants will be instructed to apply the bleaching agent (14 days-20min each)(Hismile Pty Ltd., Burleigh Waters, Qld, Australia), delivered by the bleaching custom tray.
Participants will be given a post-operative sensitivity sheet to fill in each day of Intervention.
Intervention code [1] 325317 0
Treatment: Other
Comparator / control treatment
The participants in the control group will be instructed to apply 10% carbamide peroxide bleaching agent (14 days-02 h each) delivered by the bleaching custom tray.
Control group
Active

Outcomes
Primary outcome [1] 333836 0
Color change using digital spectrophotometer
Timepoint [1] 333836 0
Baseline: before the beginning of the intervention
7 days, 14 days, 1 month, 3 months, and 6 months post-commencement of intervention
Primary outcome [2] 334421 0
Color change using color shade guide
Timepoint [2] 334421 0
Baseline: before the beginning of the intervention
7 days, 14 days, 1 month, 3 months, and 6 months post-commencement of intervention
Secondary outcome [1] 418443 0
Teeth sensitivity using visual analog scale
Timepoint [1] 418443 0
Each day of the intervention (1-14 days)

Eligibility
Key inclusion criteria
1-Patient with minimum age 18 years old.
2-Have six anterior maxillary teeth free of restorations and curious lesions.
3-color of the canine A2 or darker in the vita easy shade guide.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1-history of tooth sensitivity.
2-sever internal tooth discoloration
3-pregnant/lactating women
4-smokers
5-using orthodontic appliances
6-previous dental bleaching

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2023
Date of last participant enrolment
Anticipated
10/07/2023
Actual
Date of last data collection
Anticipated
5/01/2024
Actual
Sample size
Target
30
Accrual to date
17
Final
Recruitment outside Australia
Country [1] 25258 0
Syrian Arab Republic
State/province [1] 25258 0

Funding & Sponsors
Funding source category [1] 312907 0
University
Name [1] 312907 0
Damascus university
Country [1] 312907 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus university
Address
Mazzah highway,Damascus,Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 314586 0
None
Name [1] 314586 0
Address [1] 314586 0
Country [1] 314586 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312181 0
Ethical and scientific committee of dental research of Damascus University
Ethics committee address [1] 312181 0
Mazzah highway,Damascus,Syria
Ethics committee country [1] 312181 0
Syrian Arab Republic
Date submitted for ethics approval [1] 312181 0
29/03/2022
Approval date [1] 312181 0
09/05/2022
Ethics approval number [1] 312181 0
2607

Summary
Brief summary
A randomized controlled clinical trial aimed to evaluate the effect of Phthalimidoperoxycaproic Acid (PAP) on Vital Teeth Bleaching and post-operative sensitivity, and comparing (PAP) with the gold standard in the at home bleaching 10% carbamide peroxide (CP).
The hypothesis of the study is that the Phthalimidoperoxycaproic Acid will be more efficient in vital teeth bleaching and assessed that with low post-operative sensitivity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123762 0
Dr MHD Kamal Yabroudi
Address 123762 0
Damascus University, Mazzah Highway, Fayez Mansour Street
Country 123762 0
Syrian Arab Republic
Phone 123762 0
+963947980470
Fax 123762 0
Email 123762 0
h.kamal1996@gmail.com
Contact person for public queries
Name 123763 0
Dr MHD Kamal Yabroudi
Address 123763 0
Damascus University, Mazzah Highway, Fayez Mansour Street
Country 123763 0
Syrian Arab Republic
Phone 123763 0
+963947980470
Fax 123763 0
Email 123763 0
h.kamal1996@gmail.com
Contact person for scientific queries
Name 123764 0
Dr MHD Kamal Yabroudi
Address 123764 0
Damascus University, Mazzah Highway, Fayez Mansour Street .
Country 123764 0
Syrian Arab Republic
Phone 123764 0
+963947980470
Fax 123764 0
Email 123764 0
h.kamal1996@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?

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.