The influence of platelet-rich fibrin on pain, bleeding, swelling, and soft tissue healing after tooth extraction
| ISRCTN | ISRCTN13878305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13878305 |
| Secondary identifying numbers | TUCD-REC20160204 |
- Submission date
- 06/11/2020
- Registration date
- 09/11/2020
- Last edited
- 15/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Platelet-rich fibrin (PRF) is a biomaterial that is prepared from the patient’s own blood and can be used as a membrane for root coverage purposes after tooth extraction.
The study aimed to assess the influence of Plasma Rich Fibrin (PRF) in post-transition extraction on pain, bleeding, swelling, and soft tissue healing.
Who can participate?
Patients between 18 and 40 years of age having molar extraction.
What does the study involve?
Participants will be randomly allocated to receive either PRF or saline solution applied to the area following tooth extraction and will be followed up for 15 days.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Taibah University College of Dentistry (Saudi Arabia)
When is the study starting and how long is it expected to run for?
February 2016 to June 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Ibrahim Nourwali
ibrahim_germany@hotmail.com
Contact information
Scientific
Taibah University
Dental college
Oral and Maxillofacial department
Madinah
42313-5141
Saudi Arabia
| Phone | +966 550939364 |
|---|---|
| ibrahim_germany@hotmail.com |
Study information
| Study design | Interventional 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 patient information sheet. |
| Scientific title | The influence of platelet-rich fibrin on post-surgical complications following the removal of impacted wisdom teeth |
| Study objectives | There is no effect of platelet-rich fibrin on complications following surgical removal of lower impacted wisdom teeth |
| Ethics approval(s) | Approved 29/02/2016, Taibah University College of Dentistry REC (Al Arkam Ibn Abi Al Arkam, Al-Madinah Al-Munawarah, Medina, 42313-5141, Saudi Arabia; +966 552884839; TUCDREC@taibahu.edu.sa), ref: TUC-REC20160204 |
| Health condition(s) or problem(s) studied | Pain following wisdom tooth extraction |
| Intervention | During all the surgical procedures, all the extractions were accomplished by elevating a full-thickness mucoperiosteal flap. Following the reflection of the mucoperiosteal flap in the conventional dento-alveolar surgery with or without PRF, the osteotomy was carried out with a 1.6 mm round bur attached to a Kavo straight surgical hand-piece, using copious irrigation. All of the teeth were completely removed. In the study group, following the tooth extraction, the PRF was implanted into the extraction socket. In the control group, a sterile physiologic saline solution was used to wash the extraction sockets. The post-extraction sockets were closed by 3–0 polyglycolic acid non-resorbable sutures were used. Randomization of participants into groups using sealed envelopes. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured at 1, 2 and 6 h post-operatively: 1. Pain (Visual Analogue Scale [0 to 5]) 2. Bleeding ((Visual Analogue Scale [0 to 4]) |
| Secondary outcome measures | On days 1, 2, 3, 7 and 15 post-operatively: 1. Swelling, assessed by the surgeon |
| Overall study start date | 05/02/2016 |
| Completion date | 30/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Presence of unilateral or bilateral premolars or molars indicated for extraction 2. American Society of Anaesthesiologists (ASA) physical status classification; ASA grade I |
| Key exclusion criteria | 1. Pregnant women 2. Patients allergic to penicillin 3. Patients using other medications during the typical follow-up period |
| Date of first enrolment | 15/03/2016 |
| Date of final enrolment | 15/06/2016 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Departments of Oral and Maxillofacial Surgery
Al-Madinah Al-Munawarah
Madinah
42313-5141
Saudi Arabia
Sponsor information
University/education
College of Dentistry
Al Arkam Ibn Abi Al Arkam
Al-Madinah Al-Munawarah
Medina
42313-5141
Saudi Arabia
| Phone | +966 14861888 |
|---|---|
| TUCDREC@taibahu.edu.sa | |
| Website | https://www.taibahu.edu.sa/Pages/AR/Home.aspx |
"ROR" |
https://ror.org/01xv1nn60 |
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 | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/03/2021 | 15/03/2022 | Yes | No |
Editorial Notes
15/03/2022: Publication reference added.
06/11/2020: Trial’s existence confirmed by Taibah University.
