Can Advanced-Platelet Rich Fibrin (A-PRF), a patient blood-derived living biomaterial, prevent chronic inflammation after wisdom tooth surgery?

ISRCTN	ISRCTN12738881
DOI	https://doi.org/10.1186/ISRCTN12738881

Submission date: 09/12/2020
Registration date: 16/12/2020
Last edited: 14/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Impacted wisdom teeth are third molars at the back of the mouth that don't have enough room to emerge or develop normally. Wisdom teeth are the last adult teeth to come into the mouth (erupt). Most people have four wisdom teeth at the back of the mouth — two on the top, two on the bottom.
Surgical extraction of third molars is the most frequent dental surgery operation. The procedure often causes inflammation that affects the whole body. Studies have suggested that platelet-rich plasma (PRP) can reduce post-operative problems and improve hard and soft tissue healing. Platelet-rich fibrin (PRF) is a second generation of the platelet concentrate that prevents foreign-body responses.
This study aims to investigate the use of advanced platelet-rich fibrin (A-PRF) in reducing inflammation after wisdom tooth extraction.

Who can participate?
Otherwise healthy patients aged 18 to 65 years old, diagnosed with two impacted unilateral third molars

What does the study involve?
Participants will be randomly allocated to the test or control group.
The test group will undergo third molar removal plus the application of Advanced Platelet-Rich Fibrin (A-PRF).
The control group will receive the same procedure but with natural healing (without the use of any biomaterial).
Patients will be followed up for 1 month after surgery.

What are the possible benefits and risks of participating?
Participants will have no costs associated with surgery and laboratory tests.

Where is the study run from?
Egas Moniz Dental Clinic (Portugal)

When is the study starting and how long is it expected to run for?
November 2020 to April 2021

Who is funding the study?
1. Universidade de Santiago de Compostela (Spain)
2. Egas Moniz Institute (Portugal)

Who is the main contact?
Vanessa Machado, vmachado@egasmoniz.edu.pt

Contact information

Miss Vanessa Machado
Scientific

Campus Universitário, Quinta da Granja
Caparica
2829 - 511
Portugal

ORCID ID	0000-0003-2503-260X
Phone	+351 964805122
Email	vmachado@egasmoniz.edu.pt

Mr João Botelho
Scientific

Campus Universitário, Quinta da Granja
Caparica
2829 - 511
Portugal

ORCID ID	0000-0002-1019-8263
Phone	964805122
Email	jbotelho09@egasmoniz.edu.pt

Study information

Study design	Double-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 patient information sheet.
Scientific title	The effect of A-PRF on preventing systemic inflammation: A pilot randomized controlled clinical trial
Study acronym	WISDOM
Study objectives	Giving its anti-inflammatory properties, it could be hypothesize that A-PRF might reduce acute postoperative inflammation seen in a validated human model of acute systemic inflammation (i.e., third molar removal). Therefore, our main hypothesis is that the use of local A-PRF after lower impacted third molars would prevent acute systemic inflammation in terms of lower peripheral levels of hs-CRP compared to natural healing after this type of procedure.
Ethics approval(s)	Approved 26/11/2020, Egas Moniz Ethics Committee (Campus Universitário, Quinta da Granja, Monte de Caparica, 2829 - 511 Caparica, Portugal; +351 212946768; iuem@egasmoniz.edu.pt), ref: 903
Health condition(s) or problem(s) studied	Systemic acute inflammatory response after wisdom tooth removal in otherwise healthy patients
Intervention	The test group will undergo third molar removal plus the application of Advanced Platelet-Rich Fibrin (A-PRF) on the alveolar socket. The control group will receive the same procedure but with natural healing (without the use of any biomaterial). Randomisation process: Participants will be randomized to test or control treatment (PRF versus no-PRF) based on computer-generated random codes. The allocation will be hidden from the surgeon by opaque envelopes to be opened right before the surgical procedure. With the exception of the placement of PRF or not, procedures will be similar for both groups. Patients will be followed up for 1 month after surgery.
Intervention type	Procedure/Surgery
Primary outcome measure	Acute inflammatory response measured by hs-C-reactive protein serum levels at 24 h after intervention
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	26/11/2020
Completion date	30/04/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20
Key inclusion criteria	1. Two unilateral fully impacted mandibular third molars which have the same degree of surgical difficulty comparing one side with the other 2. Healthy patients without significant medical diseases or a history of bleeding problems 3. Adequate level of plaque control (plaque index (PI) <15%) 4. Non-smokers patients 5. Able to give written consent
Key exclusion criteria	1. Younger than 18 years old or older than 65 years old 2. Females who were pregnant or lactating 3. Females using contraceptive methods 4. Had any reported systemic illness 5. Had chronic use of any medication within 30 d prior to the study inclusion 6. Affected by periodontitis (Tonetti, Greenwell, & Kornman, 2018) 7. Signs of pericoronitis 8. Removable upper and/or lower partial dentures 9. Had periapical and periradicular radiolucencies that were detected on X-rays
Date of first enrolment	28/12/2020
Date of final enrolment	29/01/2021

Locations

Countries of recruitment

Portugal

Study participating centre

Egas Moniz Dental Clinic

Campus Universitário
Quinta da Granja
Caparica
2829 - 511
Portugal

Sponsor information

University of Santiago de Compostela
University/education

Praza do Obradoiro, 0
Santiago de Compostela
Coruña
15705
Spain

Phone	+34 881 81 10 00
Email	yagoleira@gmail.com
Website	https://www.usc.gal/gl
"ROR"	https://ror.org/030eybx10

Instituto Superior de Ciências da Saúde Egas Moniz
University/education

Campus Universitário
Quinta da Granja
Caparica
2829 - 511
Portugal

Phone	+351 964805122
Email	iuem@egasmoniz.edu.pt
Website	https://www.egasmoniz.com.pt
"ROR"	https://ror.org/01prbq409

Funders

Funder type

University/education

University of Santiago de Compostela

No information available

Instituto Superior de Ciências da Saúde Egas Moniz

No information available

Results and Publications

Intention to publish date	15/06/2021
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-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. The Egas Moniz University repository named Repositório Egas Moniz (http://comum.rcaap.pt/handle/10400.26/4758). The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Type of data: Excel When the data will become available and for how long: After completion of the research investigation (April 2021), the data will be made available for a maximum period of 3 years. After that time, the data will be removed. By what access criteria data will be shared including with whom, for what types of analyses: The data will be shared with researchers who request access to the data by email. All requests will be evaluated together with the ethics committee Egas Moniz, and after their approval they will be made available. By what mechanism, whether consent from participants was obtained, comments on data anonymisation, any ethical or legal restrictions, any other comments: Patient data will be anonymized.

Editorial Notes

14/12/2020: Trial’s existence confirmed by Egas Moniz Ethics Committee.