Pain, PostoperativePRFNCT06609967
Effect Of Autologous Platelet Rich Fibrin On Post-Operative Complications And Healing Following The Extraction
A study testing application of PRF and application of conventional surgicel in people with Pain, Postoperative and Post Operative Swelling, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
As post-operative pain, infection inflammation and infections are the main complications after the surgical extraction of the lower third molar the aim of this study is to compare the healing effects of PRF administered postoperatively Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Post Operative Swelling, Trismus
- What is being tested?
- application of PRF and application of conventional surgicel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2021to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female patients
- Patients that give their consent to the use of their information and to the administration of the drug will be the participants of the study.
- Patients with 3rd molar impactions
- Absence of systemic diseases
- age ⩾18 years and the ability to cooperate with the requirements of the study protocol.
Who cannot join
- Medically compromised patients.
- Immunocompromised patients.
- Patients that do not consent.
- Patients that are below the age of 17.
- Patients that are pregnant.
- Fully erupted molars will be excluded. smokers (\> 5 a day) will be excluded as well.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Oral and Maxillofacial Surgery, Dow University of Health Sciences
Karachi, Sindh, 75400
About this study
Official title: Effect Of Autologous Platelet Rich Fibrin (PRF) On Post-Operative Complications And Healing Following The Extractions Impacted Mandibular Wisdoms
As post-operative pain, infection inflammation and infections are the main complications after the surgical extraction of the lower third molar the aim of this study is to compare the healing effects of PRF administered postoperatively
Read the detailed description
PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7. Their post-operative complications will be checked at every subsequent visit and noted in the questionnaire. The Questionnaire is structured and will be interviewer-administered. It will comprise of basic bio-demographic data (such as name, age, sex, etc) and 3 closed-ended questions related to post-operative complications following the extraction
- Being tested
- application of PRF, application of conventional surgicel
- Keywords
- prf, extraction socket, post operative complications, wisdom tooth extractions, surgical extractions
- Medical subject headings
- Pain, Postoperative, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of PRFProcedure or surgery
PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7
application of conventional surgicelProcedure or surgery
it will be a control group in which extraction sockets will be left to heal with the natural blood clot.
| Study group | Role | What they receive |
|---|---|---|
| PRF group | Experimental | Not described Receives: Procedure: application of PRF |
| Non-PRF group | Active comparator | Not described Receives: Procedure: application of conventional surgicel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Post-operative pain will be measured using a visual analog scale in both groups i.e. conventional therapy group and PRF group on the 1st, 3rd and 7th post operative day.
Measured: 7 days
Post operative Swelling
Post operative swelling will be measured in terms of metric calculation (centimeters) in 2 sites i.e: 1. From the tragus of the ear to angle of mouth and 2. From lateral canthus of eye to angle of mandible on the 3rd and 7th post operative day.
Measured: 7 days
Trismus- Post surgical limitation in mouth opening
Trismus will be measured as the distance in (cm) between the edges of the maxillary and mandibular central incisors post surgically on the 3rd and 7th post operative day.
Measured: 7 days
Wound/ extraction socket healing
The wound healing of the extraction socket of mandibular wisdom teeth will be assessed according to Landry\'s criteria on the 7th post operative day.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start15 Nov 2021
- Primary completion1 Jun 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamza Jawed, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609967
- Sponsor's protocol ID
- Hamza001
- Acronym
- PRF
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2021
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Complete data will be shared after consent.
Publications
Passarelli PC, Romeo A, Lopez MA, De Angelis P, Desantis V, Piccirillo GB, Papa R, Papi P, Pompa G, Moffa A, Casale M, D'Addona A. Evaluation of the periodontal healing of the second mandibular molar distal site following insertion of PRF in the third molar post extraction alveolus. J Biol Regul Homeost Agents. 2020 Sep-Oct;34(5 Suppl. 3):111-118. Technology in Medicine.
PubMed 33386040
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Autologous Platelet Rich Fibrin (PRF) On Post-Operative Complications And Healing Following The Extractions Impacted Mandibular Wisdoms
- ClinicalTrials.gov ID
- NCT06609967
- Acronym / sponsor ID
- PRF / Hamza001
- Keywords
- prf, extraction socket, post operative complications, wisdom tooth extractions, surgical extractions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As post-operative pain, infection inflammation and infections are the main complications after the surgical extraction of the lower third molar the aim of this study is to compare the healing effects of PRF administered postoperatively
Detailed description
PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7. Their post-operative complications will be checked at every subsequent visit and noted in the questionnaire. The Questionnaire is structured and will be interviewer-administered. It will comprise of basic bio-demographic data (such as name, age, sex, etc) and 3 closed-ended questions related to post-operative complications following the extraction
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF group | Experimental | Procedure: application of PRF |
| Non-PRF group | Active comparator | Procedure: application of conventional surgicel |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both male and female patients
- Patients that give their consent to the use of their information and to the administration of the drug will be the participants of the study.
- Patients with 3rd molar impactions
- Absence of systemic diseases
- age ⩾18 years and the ability to cooperate with the requirements of the study protocol.
Key exclusion criteria (6 listed)
- Medically compromised patients.
- Immunocompromised patients.
- Patients that do not consent.
- Patients that are below the age of 17.
- Patients that are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of PRFPRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7 | Procedure or surgery | PRF group |
| application of conventional surgicelit will be a control group in which extraction sockets will be left to heal with the natural blood clot. | Procedure or surgery | Non-PRF group |
Primary outcome
Pain
Time frame: 7 days
Post-operative pain will be measured using a visual analog scale in both groups i.e. conventional therapy group and PRF group on the 1st, 3rd and 7th post operative day.
Post operative Swelling
Time frame: 7 days
Post operative swelling will be measured in terms of metric calculation (centimeters) in 2 sites i.e: 1. From the tragus of the ear to angle of mouth and 2. From lateral canthus of eye to angle of mandible on the 3rd and 7th post operative day.
Trismus- Post surgical limitation in mouth opening
Time frame: 7 days
Trismus will be measured as the distance in (cm) between the edges of the maxillary and mandibular central incisors post surgically on the 3rd and 7th post operative day.
Wound/ extraction socket healing
Time frame: 7 days
The wound healing of the extraction socket of mandibular wisdom teeth will be assessed according to Landry\'s criteria on the 7th post operative day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Results publication: PubMed 33386040Passarelli PC, Romeo A, Lopez MA, De Angelis P, Desantis V, Piccirillo GB, Papa R, Papi P, Pompa G, Moffa A, Casale M, D'Addona A. Evaluation of the periodontal healing of the second mandibular molar distal site following insertion of PRF in the third molar post extraction alveolus. J Biol Regul Homeost Agents. 2020 Sep-Oct;34(5 Suppl. 3):111-118. Technology in Medicine.
- Individual participant dataSharing planned: Undecided. Complete data will be shared after consent.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of PRF and application of conventional surgicel in people with Pain, Postoperative and Post Operative Swelling, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06609967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.