A comparative clinical evaluation of LED- versus laser-activated in-office tooth whitening
| ISRCTN | ISRCTN62124700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62124700 |
| Sponsor | Grigore T. Popa University of Medicine and Pharmacy |
| Funder | Investigator initiated and funded |
- Submission date
- 24/01/2026
- Registration date
- 27/01/2026
- Last edited
- 27/01/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study compares two commonly used professional tooth whitening methods—one activated by LED light and one activated by a diode laser.
Who can participate?
Adult patients with tooth discoloration.
What does the study involve?
Participants were randomly assigned to one of the two treatments. Tooth color changes were measured objectively using a digital device before and after treatment to evaluate and compare the effectiveness of the two systems.
What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration
Where is the study run from?
Grigore T. Popa University of Medicine and Pharmacy, Romania.
When is the study starting and how long is it expected to run for?
October 2025 to December 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Amititeloaie Carmen, carmen.amititeloaie@umfiasi.ro
Contact information
Principal investigator, Public, Scientific
Str. Universitatii Nr. 16
Iasi
700115
Romania
| Phone | +40744357867 |
|---|---|
| carmen.amititeloaie@umfiasi.ro |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Comparative clinical evaluation of LED- versus laser-activated in-office tooth whitening using digital spectrophotometry: a pilot randomized clinical trial | |
| Study objectives | The objective of this study is to compare the clinical effectiveness of LED-activated and diode laser–activated in-office tooth whitening systems using objective digital spectrophotometric assessment of tooth color changes. | |
| Ethics approval(s) |
Approved 28/09/2025, Scientific Research Ethics Committee of the UMF "Grigore T. Popa" Iaşi (Str. Universitatii Nr.16, Iasi, 700115, Romania; +40.232.211.818; eticacercetarii@umfiasi.ro), ref: 643 | |
| Health condition(s) or problem(s) studied | Tooth discoloration; dental aesthetics | |
| Intervention | Participants were randomly allocated to one of two intervention groups: laser-activated tooth whitening using a diode laser system and LED-activated tooth whitening using an LED light system. Both interventions were performed in a single clinical session under standardized conditions. The expected total duration of the study visit for each participant was approximately 60–90 minutes, including baseline assessment, intervention, and immediate post-treatment evaluation. There was no additional follow-up period, as all outcomes were assessed immediately after completion of the whitening procedure. Method of randomisation: Participants were randomly allocated in a 1:1 ratio using a computer-generated random allocation sequence (Microsoft Excel). Allocation concealment was ensured using sealed, opaque envelopes, which were opened on the day of treatment. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | Biolase Epic diode laser (940nm), Philips Zoom WhiteSpeed LED whitening system | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 19/12/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | All |
| Target sample size at registration | 12 |
| Total final enrolment | 12 |
| Key inclusion criteria | 1. Healthy adults aged 18–45 years 2. Extrinsic or mixed-type tooth discoloration (Vita shade A3 or darker) 3. Good oral hygiene |
| Key exclusion criteria | 1. Pregnancy or breastfeeding 2. Severe dental hypersensitivity 3. Active carious, periodontal, or oral mucosal lesions 4. Systemic diseases or known allergies to bleaching agents |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 19/12/2025 |
Locations
Countries of recruitment
- Romania
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
26/01/2026: Study’s existence confirmed by the Scientific Research Ethics Committee of the UMF "Grigore T. Popa" Iaşi, Romania.
