Condition category
Oral Health
Date applied
28/09/2020
Date assigned
14/10/2020
Last edited
14/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://uqu.edu.sa/english

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

Publication citations

Additional files

Editorial Notes

12/10/2020: Trial's existence confirmed by Umm Al-qura University Faculty of Dentistry Institutional Review Board.