The effect of platelet-rich plasma and laser in reducing post-operative complications after lower third molar extraction
| ISRCTN | ISRCTN17334706 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17334706 |
| Secondary identifying numbers | 163 |
- Submission date
- 02/04/2024
- Registration date
- 10/04/2024
- Last edited
- 10/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Extraction of impacted third molars is one of the most common surgical procedures in dental clinics, often accompanied by post-operative complications such as pain, discomfort, swelling (edema) and a locked jaw (trismus). Many surgeons tend to prescribe painkillers, non-steroidal anti-inflammatory drugs and corticosteroids after surgery and sometimes these medications have side effects. Many prior studies have sought alternative approaches to reduce these complications such as platelet-rich plasma (PRP), platelet-rich fibrin (PRF), low-level laser (light) therapy (LLLT) and aloe vera gel. This study aims to investigate the combined effect of PRP and LLLT in reducing post-operative complications and evaluate the post-surgical healing process.
Who can participate?
Healthy adults diagnosed with impacted lower third molars indicated for extraction
What does the study involve?
This study compares the effectiveness of PRP combined with a diode laser, PRP alone, or no treatment (as a control group) in reducing post-operative complications following the extraction of lower third molars. It will involve 22 patients aged between 18 and 26 years old, all diagnosed with impacted lower third molars requiring surgical extraction on both sides. Patients will be selected based on specific inclusion and exclusion criteria.
What are the possible benefits and risks of participating?
PRP and LLLT have proven effects on reducing pain and accelerating the healing process.
The surgical procedure may be accompanied by pain, edema, bleeding after surgery, and discomfort. As for PRP preparation, there is a potential risk when collecting blood such as bruising after drawing blood and patient dizziness.
Where is the study run from?
Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University, Syria
When is the study starting and how long is it expected to run for?
April 2021 to May 2023
Who is the funding of the study?
Damascus university
Who is the main contact?
Dr Rita Alsaleh, rorialsaleh@gmail.com, rita1995.alsaleh@damascusuniversity.edu.sy
Contact information
Public, Scientific, Principal Investigator
Qudsaya
Damascus
4671
Syria
| Phone | +963934899782 |
|---|---|
| rita1995.alsaleh@damascusuniversity.edu.sy |
Public
Qudsaya
Damascus
4671
Syria
| Phone | +963934899782 |
|---|---|
| rorialsaleh@gmail.com |
Study information
| Study design | Split-mouth randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | 45269_PIS_PainScales.pdf |
| Scientific title | Reducing post-operative complications after impacted lower third molars surgical extraction using platelet-rich plasma (PRP) in combination with diode laser (660 nm). Randomized Controlled Trial (RCT) |
| Study objectives | H0: there are no significant differences among the studied groups in reducing post-operative complications of lower third molars extraction in the studied indices. |
| Ethics approval(s) |
Approved 27/09/2021, Ethics Scientific Committee at Damascus University (Baramkeh, Damascus, 4671, Syria; +963(11)33923223; ap.srd@damascusuniversity.edu.sy), ref: 2255 |
| Health condition(s) or problem(s) studied | Impacted lower third molars |
| Intervention | This study is designed to compare the efficacy of platelet-rich plasma (PRP) in combination with diode laser, PRP alone, and a control group (no additional procedure as a control group) in minimizing post-operative complications after surgical extraction of lower third molars. A total of 22 patients, aged between 18 and 26 years old, diagnosed with impacted lower third molars requiring bilateral surgical extraction, will be selected to participate based on strict inclusion and exclusion criteria. Methodology: The randomization method uses sealed envelopes to allocate participants into one of the three intervention groups: PRP with diode laser, PRP alone, or control group. The study comprises three appointments for each participant: First Appointment: During this initial visit, blood is drawn from the participants for PRP preparation, and the surgical extraction procedure is performed. Second Appointment: Scheduled for the assessment of post-operative edema and trismus, this appointment allows for the immediate monitoring of the effects of the interventions. Third Appointment: Dedicated to evaluating the healing process post-extraction, this appointment facilitates the assessment of the long-term outcomes of the interventions. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain measured using a Visual Analogue Scale (VAS) on the procedure day and daily on the first 7 days following the procedure |
| Secondary outcome measures | 1. Edema measured using the tape method (the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible) at baseline, 3 days, and 7 days following the procedure 2. Healing index measured using the Gingival Healing Index (GHI) on one timepoint 7 days post-operatively 3. Trismus measured using the Maximum Interincisal Opening (MOI) at baseline, 3 days, and 7 days following the procedure |
| Overall study start date | 21/04/2021 |
| Completion date | 02/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 22 |
| Key inclusion criteria | 1. Aged between 18-30 years old 2. Require extraction of impacted lower third molars (asymptomatic, bilateral and indicated extractions (poorly placed, orthodontic reasons) and symmetrical (the angle, and difficulty of extraction)) 3. Healthy patients that have no systemic diseases that may affect the healing process 4. The surgical condition should be as similar as possible among the group (e.g. extraction time) 5. Able to give consent to enroll in the study |
| Key exclusion criteria | 1. Pre-existing medical condition that is considered a surgery contraindication 2. Pregnancy and lactation 3. Allergies to some medication (Paracetamol, Chlorhexidine) 4. Severe TMJ disorders 5. Chronic or neurological pain, and psychological disorders 6. Light sensitivity |
| Date of first enrolment | 03/04/2022 |
| Date of final enrolment | 25/04/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
4671
Syria
Sponsor information
University/education
Baramkeh
Damascus
4671
Syria
| Phone | +963 (11) 339 23223 |
|---|---|
| info@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 | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-review journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Dr Rita Alsaleh, rorialsaleh@gmail.com, rita1995.alsaleh@damascusuniversity.edu.sy. The type of data that will be shared includes the patient information sheet, and any data except any personal information such as demographic details, or any photo that can determine the patient’s identity. The timing of availability is after publication in a high-impact journal. Consent from participants was required and was obtained from each patient. Any personal data will be anonymized. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 10/04/2024 | No | Yes | ||
| Participant information sheet | 10/04/2024 | No | Yes | ||
| Participant information sheet | 10/04/2024 | No | Yes |
Additional files
Editorial Notes
03/04/2024: Study's existence confirmed by Damascus University.
