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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 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]

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

Condition category

Condition code

Oral and Gastrointestinal

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]

Treatment: Drugs

Intervention code [2]

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]

Whitening efficacy.
The whitening efficacy will be assessed by using a spectrophotometer device (Vita Easy shade) at every follow up session.

Timepoint [1]

3 Weeks post intervention

Secondary outcome [1]

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]

for every day of the intervention.

Secondary outcome [2]

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]

for every day of the intervention.

Secondary outcome [3]

gingival index

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Syrian Arab Republic

State/province [1]

Damascus

Funding & Sponsors

Funding source category [1]

University

Name [1]

Damascus University

Address [1]

Syria, Damascus, Mazzeh highway

Country [1]

Syrian Arab Republic

Primary sponsor type

University

Name

Damascus universtiy

Address

Syria, Damascus, Mazzeh highway

Country

Syrian Arab Republic

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The ethics committee of Damascus University

Ethics committee address [1]

Damascus, mazzeh highway.

Ethics committee country [1]

Syrian Arab Republic

Date submitted for ethics approval [1]

13/04/2022

Approval date [1]

09/05/2022

Ethics approval number [1]

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

Dr Ahmad Alkiwan

Address

Syria, Damascus, western mazzeh
work organisation address : Syria, Damascus, Mazzeh, Fayez Mansour street.

Country

Syrian Arab Republic

Phone

+963945042858

Fax

ahmad-kiwan@live.com

Contact person for public queries

Name

Ahmad Alkiwan

Address

Syria, Damascus, western mazzeh
work organisation address : Syria, Damascus, Mazzeh, Fayez Mansour street.

Country

Syrian Arab Republic

Phone

+963945042858

Fax

ahmad-kiwan@live.com

Contact person for scientific queries

Name

Ahmad Alkiwan

Address

Syria, Damascus, western mazzeh
work organisation address : Syria, Damascus, Mazzeh, Fayez Mansour street.

Country

Syrian Arab Republic

Phone

+963945042858

Fax

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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