The effectiveness of two types of fibrin (a protein found in human blood) in decreasing pain and improving healing after tooth extraction
| ISRCTN | ISRCTN44767135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44767135 |
| Secondary identifying numbers | IRB 143-19 |
- Submission date
- 28/09/2020
- Registration date
- 14/10/2020
- Last edited
- 07/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Some physiological changes may occur following tooth extraction, and the symptoms may affect the patient’s quality of life. Many techniques have been developed to improve pain and soft tissue healing. The aim of this study is to compare the pain and early soft tissue healing characteristics of extraction sites treated with leukocyte-and-platelet-rich fibrin (L-PRF) and advanced platelet-rich fibrin (A-PRF).
Who can participate?
Patients aged 18–50 undergoing tooth extraction
What does the study involve?
Participants are randomly allocated into three groups to be treated with advanced platelet-rich fibrin, leukocyte platelet rich fibrin, or no additional treatment after tooth extraction. Afterwards, participants in each group are assessed for pain, number of analgesics used, and early soft tissue healing.
What are the possible benefits and risks of participating?
The treatment may accelerate soft tissue healing and decrease pain. Some participants may feel unwell or faint during or after the procedure.
Where is the study run from?
Umm Al-Qura University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
October 2019 to April 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Moroj Sindi
s435007101@st.uqu.edu.sa
Contact information
Scientific
Al awali
Makkah
24372
Saudi Arabia
| Phone | +966 (0)555252409 |
|---|---|
| s435007101@st.uqu.edu.sa |
Study information
| Study design | Interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effectiveness of advanced platelet-rich fibrin in comparison with leukocyte-platelet-rich fibrin on outcome after dentoalveolar surgery |
| Study objectives | Advanced platelet-rich fibrin is more effective than leukocyte platelet-rich fibrin in decreasing post-extraction pain and early soft tissue healing. |
| Ethics approval(s) | Approved 19/01/2020, Umm Al-qura University Faculty of Dentistry Institutional Review Board (Umm Al-Qura University, Makkah, 24373, Saudi Arabia; +966 (0)125270000; irb.uqudent@uqu.edu.sa), irb: 143-19 |
| Health condition(s) or problem(s) studied | Pain and soft tissue healing after tooth extraction |
| Intervention | Patients are divided by stratified randomization into three groups: Group Ӏ: 20 patients treated with advanced platelet-rich fibrin after tooth extraction Group ӀӀ: 20 patients treated with leukocyte platelet-rich fibrin after tooth extraction Group ӀII: 20 patients receive no additional treatment Afterwards, patients in each group are assessed for post-extraction pain on the first and second day by VAS, the number of analgesics taken after 6, 12, 18, 24 hours, and early soft tissue healing at the first and second week by LWHI. Follow up is weekly for 2 weeks. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Leukocyte platelet-rich fibrin, advanced platelet-rich fibrin |
| Primary outcome measure | 1. Pain measured using a visual analogue scale (VAS) after 1 and 2 days 2. Number of analgesics taken, recorded after 6, 12, 18 and 24 hours 3. Soft tissue healing measured using the Landry Wound Healing Index (LWHI) after 1 and 2 weeks |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/10/2019 |
| Completion date | 29/04/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Able to speak and communicate in Arabic and English 2. Single posterior tooth extraction 3. Aged 18–50 4. Male or female 5. Surgical or extraction site free of active infection 6. Free of significant systemic disease |
| Key exclusion criteria | 1. Patients undergoing chemotherapy and radiotherapy 2. Mentally retarded 3. Medical condition affecting wound healing such as uncontrolled diabetes mellitus 4. Pregnant women |
| Date of first enrolment | 19/01/2020 |
| Date of final enrolment | 14/04/2020 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Makkah
24236
Saudi Arabia
Sponsor information
University/education
Al Abdeyah
Mecca
24373
Saudi Arabia
| Phone | +966 (0)125270000 |
|---|---|
| s435007101@st.uqu.edu.sa | |
| Website | https://uqu.edu.sa/english |
"ROR" |
https://ror.org/01xjqrm90 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| 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 journal at the end of December 2020. The study protocol and informed consent form will be made available. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Arwa Almatrafi (Aroooost17@hotmail.com). The data will be available for anyone who wishes to access the data for any analysIs. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/05/2021 | 07/12/2021 | Yes | No |
Editorial Notes
07/12/2021: Publication reference added.
12/10/2020: Trial's existence confirmed by Umm Al-qura University Faculty of Dentistry Institutional Review Board.
