Effect of hyaluronic acid on the oral mucosa healing after diode laser biopsies
| ISRCTN | ISRCTN14643405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14643405 |
| Secondary identifying numbers | 5289 |
- Submission date
- 29/08/2024
- Registration date
- 06/09/2024
- Last edited
- 06/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Oral mucosa can be affected by lesions which interfere with many functions such as eating, speaking, and swallowing. Oral fibroma is one of these lesions that appears commonly in the oral cavity. It is the most common reactive lesion in the oral cavity. Fibroma results from a chronic repair process that includes granulation tissue and scar formation resulting in a fibrous submucosal mass. This lesion doesn’t have a risk of malignancy transformation. The most common sites in the oral cavity are the tongue, buccal mucosa, and lower labial mucosa. An excisional biopsy is the treatment choice for irritation fibroma, either by surgical scalpel, electric scalpel, cryosurgery, or diode laser. Diode laser based on many studies is a very sufficient way of taking excisional biopsies, however, it has a thermal effect on the oral mucosa that affects mucosal healing, which makes it take longer to heal compared to the surgical conventional way. Accordingly, hyaluronic acid (HA) is now used to accelerate the mucosal healing process after excision using lasers in general.
Who can participate?
Patients aged between 20 and 40 years old who have oral fibroma and systemic diseases free
What does this study involve?
Participants are randomly allocated into three groups: Group A (HA gel + diode laser), Group B (HA mouthwash + diode laser), and Group C (control group, diode laser only). HA use instructions are given to the first two groups, and oral hygiene instructions are given to all groups.
What are the possible benefits and risks of participating?
Benefits may include healing acceleration due to the HA application after taking the excisional biopsy of the oral fibroma using a diode laser.
Possible risks might be experiencing some pain and discomfort after taking the biopsy, and a slow healing process due to the thermal effect of the diode laser and the ineffectiveness of the HA.
Where is the study run from?
Damascus University, Syria
When is the study starting and how long is it expected to run for?
June 2023 to October 2025
Who is funding the study?
Damascus University, Syria
Who is the main contact?
Dr. Amr Alyafi, amr.alyafi@hotmail.com, amr.alyafi97@damascusuniversity.edu.sy
Contact information
Public, Scientific, Principal Investigator
Telyani
Damascus
4671
Syria
 ORCID ID |
0009-0001-8761-8019 |
|---|---|
| Phone | +963947880112 |
| amr.alyafi97@damascusuniversity.edu.sy |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Other, Treatment, Efficacy |
| Participant information sheet | 46009_PIS[InformedConsent].pdf |
| Scientific title | Studying the effect of hyaluronic acid on mucosal healing after excisional oral biopsies with 810 nm diode laser |
| Study objectives | h0: There are no statistical differences between the three studied groups. (HA gel group, HA mouthwash group, and only diode laser group) h1: There are statistically significant differences between the three studied groups. |
| Ethics approval(s) |
Approved 07/08/2023, Scientific Ethics Committee at Damascus University (Baramkeh, Damascus, 4671, Syria; +9631133923223; ap.srd@damascusuniversity.edu.sy), ref: 3437 |
| Health condition(s) or problem(s) studied | Mucosal healing after oral excisional biopsies |
| Intervention | This study is designed to evaluate the effect of hyaluronic acid (HA; Mouthwash - Gel) on mucosal healing after oral excisional biopsies with an 810 nm diode laser. A simple method of randomisation is used that involves writing the group name (A, B, C) on a piece of paper inside three envelopes, and letting the patient choose the envelope randomly. A brief methodology for each treatment arm: -Group A (HA gel group + diode laser): After taking the excisional biopsy with a diode laser (with parameters of 810 nm, 4W) which takes approximately less than 5 minutes, the patients will be given topical hyaluronic acid gel 0.2% to apply on the wound 3 times daily for 10 days. After each appliance, the patient should not eat or drink for an hour. -Group B (HA mouthwash group + diode laser): After taking the excisional biopsy with a diode laser (with parameters of 810 nm, 4W) which takes approximately less than 5 minutes, the patients will be given hyaluronic acid mouthwash 0.025% to rinse with 3 times daily out of brushing times for 10 days, by keeping it for a minute in the mouth and then spitting it out. After each rinsing the patient should not eat or drink for an hour. -Group C (diode laser only): After taking the excisional biopsy with a diode laser (with parameters of 810 nm, 4W) which takes approximately less than 5 minutes, the wound will be left to heal spontaneously without allying any drug. Percentage healing index (PHI: is an index that helps determine the healing process by taking a picture of the excision wound after the procedure immediately and after every follow-up visit, and then using the Adobe Photoshop application on PC to measure the excision wound area in square millimeters. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Excision wound area measured using the Percentage Healing Index (PHI) after the excision immediately (T0), at day 4 (T1), week 1 (T2), week 2 (T3), and 1 month (T4) |
| Secondary outcome measures | Pain is measured using a Visual Analogue Scale ( VAS) at day 4, week 1, week 2, and 1 month |
| Overall study start date | 24/06/2023 |
| Completion date | 24/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Patients that have oral fibromas on the non-keratinized oral mucosa 2. Excisional biopsy wounds with a diameter of less than 10mm |
| Key exclusion criteria | 1. People who have systemic diseases 2. Smokers 3. Alcoholics |
| Date of first enrolment | 01/07/2023 |
| Date of final enrolment | 01/07/2025 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
4671
Syria
Sponsor information
University/education
Baramkeh
Damascus
4671
Syria
| Phone | +9631133923223 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | https://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 | 01/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sets will be generated and analyzed during the current study and will be available upon request from Amr Alyafi, amr.alyafi@hotmail.com, amr.alyafi97@damascusuniversity.edu.sy |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 02/09/2024 | No | Yes | ||
| Participant information sheet | 02/09/2024 | No | Yes |
Additional files
Editorial Notes
30/08/2024: Study's existence confirmed by the Faculty of Dentistry, Damascus University.
