Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000547640
Ethics application status
Approved
Date submitted
20/03/2023
Date registered
22/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
22/05/2023
Date results information initially provided
28/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of age on effectiveness, gingival irritation, and sensitivity following at home bleaching.
Scientific title
Evaluating the effect of age on effectiveness, gingival irritation, and sensitivity following at home bleaching using 10% carbamide peroxide 2 hours a day for 3 weeks.
Secondary ID [1] 308629 0
Nil known
Universal Trial Number (UTN)
U1111-1289-9543
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Teeth discoloration 328532 0
Condition category
Condition code
Oral and Gastrointestinal 325551 325551 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
At home tooth bleaching with 10% carbamide peroxide applied for 2 hours a day for 3 weeks, the patients were instructed to apply the material at the same time every day
The patients will be divided to three groups depending on their age as follows: 14-18 years old age group, 20-40 years old age group, 50 years old or higher group.
The carbamide peroxide will be applied to the facial surface of the upper six anterior teeth via individual trays made with 1 mm thick ethylene-vinyl acetate.
Intervention code [1] 325086 0
Treatment: Drugs
Intervention code [2] 326039 0
Treatment: Other
Comparator / control treatment
This study is investigating the effect of at home bleaching on different age groups. so the patients in the 20-40 age group is considered the control as the effect of tooth bleaching on patients in this age group had been thoroughly studied in other trials.
Control group
Active

Outcomes
Primary outcome [1] 333431 0
Whitening efficacy.
The whitening efficacy will be assessed by using a spectrophotometer device (Vita Easy shade) at every follow up session.
Timepoint [1] 333431 0
3 Weeks post intervention
Secondary outcome [1] 417089 0
teeth sensitivity
the sensitivity will be assessed by asking the patients to fill a daily survey (Visual analog scale) for every day of the intervention.
Timepoint [1] 417089 0
for every day of the intervention.
Secondary outcome [2] 417090 0
Gingival irritation.
gingival irritation will be measured for every day of the intervention by asking the patients to fill a daily survey indicating if they felt any gingival irritaion during the intervention.
Timepoint [2] 417090 0
for every day of the intervention.
Secondary outcome [3] 421668 0
gingival index
Timepoint [3] 421668 0
3 weeks post treatment.

Eligibility
Key inclusion criteria
Healthy patients with at least 6 maxillary anterior sound teeth.
The canine must have a shade of A2 or darker according to the vita classic shade guide.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with the 6 maxillary anterior teeth having active carious lesions, or crowns, or large restorations.
Smoking or heavy drinking patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 analysing the results/data
Intervention assignment
Other
Other design features
All the patients will be receiving the same treatment, but they will be assigned to one of three groups according to thier age.
Patients aged 14-18 years will be assigned to a group.
Patients aged 20-40 years will be assigned to another group.
Patients aged 50 years old or higher will be assigned to another group as well.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using G-Power program, a similar study using the same concentraion and application time of carbamide peroxide was used to evaluate the sample size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2023
Actual
1/10/2023
Date of last participant enrolment
Anticipated
3/12/2023
Actual
3/12/2023
Date of last data collection
Anticipated
1/04/2024
Actual
1/01/2024
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 25327 0
Syrian Arab Republic
State/province [1] 25327 0
Damascus

Funding & Sponsors
Funding source category [1] 312868 0
University
Name [1] 312868 0
Damascus University
Country [1] 312868 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus universtiy
Address
Syria, Damascus, Mazzeh highway
Country
Syrian Arab Republic
Secondary sponsor category [1] 315206 0
None
Name [1] 315206 0
Address [1] 315206 0
Country [1] 315206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312145 0
The ethics committee of Damascus University
Ethics committee address [1] 312145 0
Damascus, mazzeh highway.
Ethics committee country [1] 312145 0
Syrian Arab Republic
Date submitted for ethics approval [1] 312145 0
13/04/2022
Approval date [1] 312145 0
09/05/2022
Ethics approval number [1] 312145 0
2600

Summary
Brief summary
The mechanism of bleaching using oxidizing agents have been thoroughly disscussed in the literature, and it has been suggested that hydrogen peroxide particles can difusse through dentin tubules to reach and break the rings of the pigmenting molecules, converting them to carbon chanis which are assumed to be lighter in color. This mechanism renders the tooth whiter, but could also cause tooth sensitivity due to the irritation of the pulp by hydrogen peroxide paricles. In addition, gingival tissue might get damaged if came in contact with the whitening solution.
It has been also stated that the diameter of dentin tubles decreases with age, and the blood supply of the gingival tissue decreases as well. These changes may hamper the progression of hydrogen peroxide paricles through dentin and into the pulp tissue and render the gingval tissue more susceptible to inflammation.
Based on these statements, we made the hypothesis that the effectivness and post sensitivity of tooth bleaching will decrease with age and gingival irritation during tooth bleaching will increase.
So this study will be evaluating the effect of age difference on the whitening efficacy and side effects of at home bleaching using carbamide peroxide. Patients will be assigned to one of three groups depending on thier age, group 1 (14-18 years old), group 2 (20-40 years old), group 3 (5o years old or higher), and a bleaching procedure using carbamide peroxide 10% will be applied to all patients 2 hours a day for 3 weeks.
During the procedure, tooth shade, sensitivity, and gingival irritation will be recorded weekly. Tooth sahde will be measured using a spectrophotometer device (Vita Easy sahde), tooth sensitivity will be measured using a daily visual analog scale (VAS), and for gingival irritation, patients will fill a daily survey indicating if they felt any discomfort or irritation in thier gingiva, and gingival index will be recorded for the upper arch every week during the procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123642 0
Dr Ahmad Alkiwan
Address 123642 0
Syria, Damascus, western mazzeh
work organisation address : Syria, Damascus, Mazzeh, Fayez Mansour street.
Country 123642 0
Syrian Arab Republic
Phone 123642 0
+963945042858
Fax 123642 0
Email 123642 0
ahmad-kiwan@live.com
Contact person for public queries
Name 123643 0
Dr Ahmad Alkiwan
Address 123643 0
Syria, Damascus, western mazzeh
work organisation address : Syria, Damascus, Mazzeh, Fayez Mansour street.
Country 123643 0
Syrian Arab Republic
Phone 123643 0
+963945042858
Fax 123643 0
Email 123643 0
ahmad-kiwan@live.com
Contact person for scientific queries
Name 123644 0
Dr Ahmad Alkiwan
Address 123644 0
Syria, Damascus, western mazzeh
work organisation address : Syria, Damascus, Mazzeh, Fayez Mansour street.
Country 123644 0
Syrian Arab Republic
Phone 123644 0
+963945042858
Fax 123644 0
Email 123644 0
ahmad-kiwan@live.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
age of the patients.
teeth shades during all folllow up appointments.
tooth sensitivity and gingval irritation surveys and gingval index for all follow up appointments.
When will data be available (start and end dates)?
Immediately following publication and will be available for 5 years after publication.
Available to whom?
anyone who wishes to access it.
Available for what types of analyses?
any purpose.
How or where can data be obtained?
The data can be obtanied by contacting the corresponding author via the following email address : milly.hussam@damascusuniversity.edu.sy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo the results are not available yet

Documents added automatically
No additional documents have been identified.