Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Moroj Sindi
ORCID ID
Contact details
Al awali
Makkah
24372
Saudi Arabia
+966 (0)555252409
s435007101@st.uqu.edu.sa
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRB 143-19
Study information
Scientific title
The effectiveness of advanced platelet-rich fibrin in comparison with leukocyte-platelet-rich fibrin on outcome after dentoalveolar surgery
Acronym
Study hypothesis
Advanced platelet-rich fibrin is more effective than leukocyte platelet-rich fibrin in decreasing post-extraction pain and early soft tissue healing.
Ethics approval
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
Study design
Interventional single-blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
10/10/2019
Overall trial end date
29/04/2020
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
60
Total final enrolment
60
Participant 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
Recruitment start date
19/01/2020
Recruitment end date
14/04/2020
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Saudi Arabia
Alabdeyah uqudent
Makkah
24236
Saudi Arabia
Sponsor information
Organisation
Umm al-Qura University
Sponsor details
Al Abdeyah
Mecca
24373
Saudi Arabia
+966 (0)125270000
s435007101@st.uqu.edu.sa
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement
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.
Intention to publish date
31/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list