Comparison of three laser settings in the treatment of oral canker sore
| ISRCTN | ISRCTN13865282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13865282 |
| Secondary identifying numbers | 3331 |
- Submission date
- 30/06/2023
- Registration date
- 07/07/2023
- Last edited
- 10/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
An aphthous ulcer, also known as a canker sore, is a common type of painful sore that forms inside the mouth. It appears as a round or oval lesion with a white or yellowish center and a red border. Aphthous ulcers can be quite uncomfortable and can make it difficult to eat, drink, or speak.
Laser treatment has been used as an alternative or adjunctive therapy for aphthous ulcers. The procedure involves the use of a laser beam to target and treat the affected area. The laser energy is applied to the ulcer, which helps promote healing and alleviate symptoms.
This study aimed to compare three types of laser in the treatment of aphthous ulcers.
Who can participate?
Adults from age 20-40 years having one or more aphthous ulcers.
What does the study involve?
Participants will be randomly allocated to receive one of three types of laser treatment or inactivated laser as a placebo. Assessment of pain, acceleration of healing, redness, patient satisfaction with treatment and recurrence.
What are the possible benefits and risks of participating?
Participants will have less pain sensation, acceleration of healing as well as improved quality of life. These types of lasers are safe and cause no harm to patients, regardless of their age and health condition.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
June 2019 to December 2022
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr. Esra'a AlHerafi, esraa.herafi.94@gmail.com
Contact information
Scientific
AlThawra Street
Damascus
-
Syria
 ORCID ID |
0009-0009-8451-6445 |
|---|---|
| Phone | +963 991415924 |
| esraa94.alherafi@damascusuniversity.edu.sy |
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, Efficacy |
| Participant information sheet | 43875 PIS (Arabic).pdf |
| Scientific title | A comparative study among three different wavelengths of low level laser on recurrent aphthous ulceration management |
| Study objectives | Studies suggested that low-level laser therapy is a suitable alternative or adjunct treatment option for recurrent aphthous ulcers. However, more clinical trials are required to be conducted to compare the efficacy of different wavelengths in order to ascertain their efficacy in the clinical setting |
| Ethics approval(s) |
Approved 09/09/2019, Damascus University (Rector Baramkeh, Damascus, 3331, Syria; +963 555063806; info@damascusuniversity.edu.sy), ref: 3331 |
| Health condition(s) or problem(s) studied | Management of patients with recurrent aphthous ulcers |
| Intervention | Treating recurrent aphthous ulcers on 64 patients (divided into 4 groups) with three laser wavelength (808nm,660nm,635nm) controlled with placebo as application of an inactivated laser as follows: 1. GaAs 635 nm gallium arsenide laser: Power: 220 milliwatts Fluency: 4.2 J/cm³ Depth of tissue: 1 cm The necessary irradiation time(treatment time): 19 seconds / 2 times, separated by 30 seconds rest Laser beam spot size: 0.5 cm² Irradiance: 0.34 W/cm2 Application method: direct contact . (to focus the rays over the ulcer area) 2. AlGaInP 660 nm Aluminum gallium indium phosphide laser: Power: 150 milliwatts Fluency: 4.1 J/cm³ Depth of tissue: 1 cm Irradiation time: Treatment Time: 27 seconds/twice, with 30 seconds rest between them Laser beam spot size: 0.5 cm² Irradiance: 0.24 W/cm² Application method: direct contact. 3. GaAlAs 808 nm gallium aluminum arsenide laser: Power: 250 milliwatts Fluency: 4 J/cm³ Depth of tissue: 1 cm Irradiation time: Treatment Time: 16 seconds/twice, with 30 seconds rest between them Laser beam spot size: 0.5 cm² Irradiance: 0.40 W/cm² Application method: direct contact. The samples were sorted randomly, where 4 similar classifiers containing 4 symbols (English letters A, B, C, D) were placed, where each group had a previously defined symbol, and the classifiers were randomly drawn so that the first sixteen patients were entered in the group that was drawn first and The second sixteen patients in the group that were withdrawn secondly, and so on... with the help of an assistant researcher. Follow up for 7 days. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Dose response |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Klas-DX Intelligen LLLT Dose Unit |
| Primary outcome measure | 1. Pain is measured using a visual analogue scale (VAS) at baseline, before treatment, directly after treatment, and on days 2, 3, 5, 7 after treatment. 2. Lesion size is measured using dental probe at baseline, before starting the treatment, and on days 3, 7. 3. Erythema is measured using a scale based on Greer et al rules on a 4-point scale at baseline before starting treatment and immediately after treatment, and on days 3, 7. 4. Patient Satisfaction Index is measured using VAS scale after ulcer healing. |
| Secondary outcome measures | Recurrence is measured after one month in same place of treatment. |
| Overall study start date | 11/06/2019 |
| Completion date | 13/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 64 |
| Total final enrolment | 64 |
| Key inclusion criteria | 1. Patients with one or more aphthous lesion. 2. The lesion site on the buccal or labial oral mucosa, tongue, or floor of the mouth. 3. The patient has a history of recurrence. 4. No more than 48 hours have passed since the appearance of the lesion until the working day. 5. The diameter of the ulcer does not exceed 5 mm. 6. Age of 20 to 40 years. 7. The patient can attend the follow-up. 8. no other treatments for the present apthous ulcers. 9. Avoid pungent foods and acidic drinks during the follow-up period. |
| Key exclusion criteria | 1. Smokers 2. Patients with systemic conditions related to oral ulcers such as Crohn's disease 3. Patients taking antibiotics or anti-inflammatory drugs during the month before treatment |
| Date of first enrolment | 06/10/2019 |
| Date of final enrolment | 20/09/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah High Way
Damascus
-
Syria
Sponsor information
University/education
Damascus University Rector Baramkeh
Damascus
-
Syria
| Phone | +963 1133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
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 | 01/10/2023 |
|---|---|
| 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 | 07/07/2023 | No | Yes | ||
| Protocol file | 07/07/2023 | No | No |
Additional files
Editorial Notes
10/07/2023: Internal review.
07/07/2023: Trial's existence confirmed by Damascus University
