Comparison between three types of at-home dental bleaching for effects and tooth sensitivity
| ISRCTN | ISRCTN23096480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23096480 |
| Secondary identifying numbers | 3833 |
- Submission date
- 02/04/2023
- Registration date
- 12/04/2023
- Last edited
- 03/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to compare the bleaching effects of three different at-home bleaching systems and their longevity after a 6-month follow-up.
Who can participate?
Healthy adults aged 18-35 years old
What does the study involve?
Six anterior upper teeth will be bleached with one of the study's materials (either Opalescence 20% carbamide peroxide, Dazzling white paint-on, or Whitelight system) for each patient. The visual analog scale (VAS) scores and color change values will be assessed to study tooth sensitivity and bleaching longevity.
What are the possible benefits and risks of participating?
Regarding the benefits of participating, participants may get a shiny and whiter smile. All materials used in this trial are safe and should not cause any additional risks. It is crucial for the dentist to minimize the side effects of the treatment and improve the quality of life of his patients.
When is the study starting and how long is it expected to run for?
September 2020 to March 2022
Where is the study run from?
Damascus University (Syria)
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Eenass Krayem, eenasskrayem@gmail.com (Syria)
Contact information
Scientific
Barza
Damascus
0096311
Syria
 ORCID ID |
0000-0003-4328-8836 |
|---|---|
| Phone | +963 949347992 |
| eenasskrayem@damascusuniversity.edu.sy |
Public
Barza
Damascus
0096311
Syria
| Phone | +963 949347992 |
|---|---|
| eenasskrayem@gmail.com |
Study information
| Study design | Interventional single-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | 43428_PIS_Arabic.pdf |
| Scientific title | Evaluation of the tooth sensitivity and efficacy of two systems of over-the-counter teeth whitening products compared with at-home bleaching with carbamide peroxide: A randomized clinical trial |
| Study objectives | The study will evaluate the tooth sensitivity and efficacy of two over-the-counter dental bleaching products compared with traditional at-home bleaching with 20% carbamide peroxide |
| Ethics approval(s) | Approved 23/12/2020, Damascus University (Rector Baramkeh, Damascus, Syria; +966555063806; no email provided), ref: MS3833 |
| Health condition(s) or problem(s) studied | Assessment of tooth sensitivity and the efficacy of dental bleaching products |
| Intervention | This study is a randomized controlled clinical trial. Participants were divided randomly into three groups by an external person: Group A: Participants were instructed to apply 20% carbamide peroxide bleaching material using a customized tray (14 days for 4 h each day) (Opalescence PF, Ultradent Products Inc. USA) Group B: Participants were instructed to use WhiteLight system (an over-the-counter dental bleaching product consisting of prefabricated silicon trays with two carbamide peroxide gel containers and a compact LED unit for activation) (14 days for 30 minutes per day with a light transmitter) Group C: Participants were instructed to use Dazzling white paint-on (an over-the-counter dental bleaching product containing hydrogen peroxide) (14 days for 10 min twice a day after tooth brushing) The bleaching materials are applied individually by participants themselves at their homes. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Opalescence® PF™ (20% carbamide peroxide), Dazzling White (hydrogen peroxide), WhiteLight system (carbamide peroxide) |
| Primary outcome measure | 1. Tooth sensitivity measured using a visual analogue scale (VAS) at baseline, and days 1, 2, 3, 4, 5, 7 and 14 days of bleaching. 2. Color change measured using the Vita easy shade spectrophotometer at baseline, and 7 and 14 days of bleaching, 2 weeks and 6 months after bleaching |
| Secondary outcome measures | There are no secondary outcomes measures |
| Overall study start date | 01/09/2020 |
| Completion date | 10/03/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 39 |
| Total final enrolment | 39 |
| Key inclusion criteria | 1. Good general health 2. Adults (aged between 18 and 35 years old) 3. No caries or restoration on the six maxillary anterior teeth 4. Permanent teeth with a shade of A2 or darker on the shade guide (Vitapan Classical, Vita Zahnfabrik) 5. No history of tooth sensitivity 6. Availability for the follow-ups |
| Key exclusion criteria | 1. Poor oral hygiene and general health 2. Current or previous use of bleaching agents 3. A history of allergies to tooth bleaching products 4. Orthodontic treatment 5. Parafunctional habits such as bruxism 6. Pregnant or lactating women 7. Advanced periodontal disease or active carious lesions 8. Tetracycline-stained teeth 9. Tooth hypersensitivity or deep cracks in the teeth 10. Smoking |
| Date of first enrolment | 01/02/2021 |
| Date of final enrolment | 10/01/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah High Way
Damascus
0096311
Syria
Sponsor information
University/education
Rector Baramkeh
Damascus
0096311
Syria
| Phone | +963 1133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 10/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact and peer-reviewed journal |
| IPD sharing plan | The datasets during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 12/04/2023 | No | Yes | ||
| Protocol file | 12/04/2023 | No | No | ||
| Basic results | 14/07/2023 | No | No | ||
| Dataset | 01/08/2023 | No | No | ||
| Results article | 31/05/2024 | 03/06/2024 | Yes | No |
Additional files
Editorial Notes
03/06/2024: Publication reference added.
01/08/2023: A dataset has been uploaded.
14/07/2023: The basic results have been uploaded to the study outputs table.
12/04/2023: Trial's existence confirmed by Damascus University (Syria).
