Impacted Mandibular Third MolarPRF-M3MNCT07672951
Effect of Platelet-Rich Fibrin on Postoperative Pain, Trismus, and Edema After Mandibular Third Molar Surgery
A study testing Platelet-rich fibrin (PRF) and Sterile Absorbable Gelatin Sponge in people with Impacted Mandibular Third Molar and Postoperative Pain, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
Trial summary
Impacted mandibular third molars are among the most commonly encountered conditions in oral and maxillofacial surgery. Surgical removal of these teeth is frequently associated with postoperative complications such as pain, facial swelling, and trismus, which may affect patients' daily activities and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Impacted Mandibular Third Molar, Postoperative Pain, Trismus
- What is being tested?
- Platelet-rich fibrin (PRF) and Sterile Absorbable Gelatin Sponge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Dec 2025to 22 May 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 to 50 years Patients with impacted mandibular third molars indicated for surgical extraction Mesioangular or vertical impactions (Winter classification) Class II or Class III impactions, Position B or C (Pell and Gregory classification) Patients who provide written informed consent
Who cannot join
- Pregnant or lactating females Patients with systemic diseases affecting healing (e.g., uncontrolled diabetes, immunocompromised states) Smokers Patients on medications affecting bone or soft tissue healing Patients with acute infection at the surgical site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus, and Edema Following Surgical Removal of Mandibular Third Molars
Impacted mandibular third molars are among the most commonly encountered conditions in oral and maxillofacial surgery. Surgical removal of these teeth is frequently associated with postoperative complications such as pain, facial swelling, and trismus, which may affect patients' daily activities and quality of life.
Platelet-rich fibrin (PRF) is an autologous platelet concentrate prepared from the patient's own blood and contains various growth factors that may promote wound healing and reduce postoperative inflammation. The present randomized controlled trial aims to evaluate the effectiveness of PRF in reducing postoperative pain, trismus, and facial swelling after surgical removal of mandibular third molars.
Read more
Participants with impacted mandibular third molars meeting the eligibility criteria will be randomly allocated into two groups. The intervention group will receive PRF placement in the extraction socket, while the control group will receive sterile absorbable gelatin sponge (Gelfoam) after tooth removal. Postoperative pain, mouth opening, and facial swelling will be assessed preoperatively and on the first and seventh postoperative days.
The findings of this study may help determine whether PRF improves postoperative recovery following mandibular third molar surgery.
Read the detailed description
Impacted mandibular third molars frequently require surgical removal and represent one of the most commonly performed procedures in oral and maxillofacial surgery. Postoperative complications such as pain, facial swelling, and trismus commonly occur following surgical extraction and may negatively affect oral function and quality of life.
Various approaches have been proposed to reduce postoperative morbidity, including nonsteroidal anti-inflammatory drugs, corticosteroids, cold therapy, hyaluronic acid, and other adjunctive methods. Platelet-rich fibrin (PRF) is a second-generation autologous platelet concentrate that contains a fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors. These biological mediators contribute to angiogenesis, tissue regeneration, collagen synthesis, and wound healing.
The purpose of this randomized controlled trial is to evaluate the effects of platelet-rich fibrin on postoperative pain, trismus, and facial swelling following surgical removal of mandibular third molars.
Eligible participants aged 18 to 50 years with impacted mandibular third molars fulfilling the inclusion criteria will be recruited from the Department of Oral and Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. After obtaining written informed consent, participants will be randomly assigned to one of two groups:
PRF group: Platelet-rich fibrin will be prepared from the patient's venous blood and placed into the extraction socket before wound closure.
Control group: Sterile absorbable gelatin sponge (Gelfoam) will be placed into the extraction socket before wound closure.
Standardized surgical procedures, local anesthesia, medications, and postoperative instructions will be provided to all participants.
Outcome measures will include:
Postoperative pain assessed using the Visual Analog Scale (VAS). Trismus assessed by maximum interincisal opening measured in millimeters. Facial swelling assessed using standardized facial measurements. Measurements will be recorded preoperatively and on postoperative days 1 and 7.
The primary outcomes are postoperative pain and trismus, while facial swelling is considered a secondary outcome. Statistical analysis will compare outcomes between the two groups to determine whether PRF improves postoperative recovery after mandibular third molar surgery.
- Being tested
- Platelet-rich fibrin (PRF), Sterile Absorbable Gelatin Sponge
- Keywords
- Platelet-Rich Fibrin, Mandibular Third Molar, Third Molar Surgery, Postoperative Pain, Trismus, Facial Swelling, Edema
- Medical subject headings
- Pain, Postoperative, Trismus, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Biological
Platelet-rich fibrin (PRF) will be prepared from 10 mL of autologous venous blood collected from the participant. The blood sample will be centrifuged at 2700 rpm for 12 minutes to obtain the fibrin clot. Following surgical extraction of the mandibular third molar, the PRF clot will be placed into the extraction socket before wound closure.
Sterile Absorbable Gelatin SpongeDevice
Following surgical extraction of the mandibular third molar, a sterile absorbable gelatin sponge (Gelfoam) will be placed into the extraction socket before wound closure. Standard postoperative medications and instructions will be provided to all participants.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Fibrin (PRF) Group | Experimental | Participants undergoing surgical removal of impacted mandibular third molars will receive platelet-rich fibrin (PRF) prepared from autologous venous blood and placed into the extraction socket before wound closure. Standard postoperative medications and instructions will be provided. Receives: Biological: Platelet-rich fibrin (PRF) |
| Gelfoam Control Group | Active comparator | Participants undergoing surgical removal of impacted mandibular third molars will receive sterile absorbable gelatin sponge (Gelfoam) placed into the extraction socket before wound closure. Standard postoperative medications and instructions will be provided. Receives: Device: Sterile Absorbable Gelatin Sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded and compared between the platelet-rich fibrin and Gelfoam groups.
Measured: Preoperative baseline, postoperative day 1, and postoperative day 7
Postoperative Trismus
Trismus will be assessed by measuring the maximum interincisal opening in millimeters using a vernier caliper. The distance between the upper and lower central incisors at maximum mouth opening will be recorded and compared between the study groups.
Measured: Preoperative baseline, postoperative day 1, and postoperative day 7
Postoperative Facial Swelling (Edema)
Facial swelling will be assessed using linear facial measurements taken with a measuring tape. Measurements will include the distance between the angle of the mandible and lateral canthus of the eye, tragus to corner of the mouth, and tragus to soft tissue pogonion. The average of these measurements will be used to calculate facial dimension and assess postoperative edema. Values will be compared between the platelet-rich fibrin and Gelfoam groups.
Measured: Preoperative baseline, postoperative day 1, and postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start9 Dec 2025
- Primary completion16 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third MolarStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive platelet-rich fibrin (PRF) placed in the extraction socket following mandibular third molar surgery, while the control group will receive sterile absorbable gelatin sponge (Gelfoam). Outcomes will be assessed preoperatively and on postoperative days 1 and 7.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAEC General Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sumbal Tariq, PAEC General Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672951
- Sponsor's protocol ID
- OMFS-PRF-2026-01
- Other IDs
- PAEC
- Acronym
- PRF-M3M
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not required
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus, and Edema Following Surgical Removal of Mandibular Third Molars
- ClinicalTrials.gov ID
- NCT07672951
- Acronym / sponsor ID
- PRF-M3M / OMFS-PRF-2026-01
- Keywords
- Platelet-Rich Fibrin, Mandibular Third Molar, Third Molar Surgery, Postoperative Pain, Trismus, Facial Swelling, Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- PAEC General Hospital, IslamabadUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 16 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 29 Jun 2026 (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.
Impacted mandibular third molars are among the most commonly encountered conditions in oral and maxillofacial surgery. Surgical removal of these teeth is frequently associated with postoperative complications such as pain, facial swelling, and trismus, which may affect patients' daily activities and quality of life.
Platelet-rich fibrin (PRF) is an autologous platelet concentrate prepared from the patient's own blood and contains various growth factors that may promote wound healing and reduce postoperative inflammation. The present randomized controlled trial aims to evaluate the effectiveness of PRF in reducing postoperative pain, trismus, and facial swelling after surgical removal of mandibular third molars.
Participants with impacted mandibular third molars meeting the eligibility criteria will be randomly allocated into two groups. The intervention group will receive PRF placement in the extraction socket, while the control group will receive sterile absorbable gelatin sponge (Gelfoam) after tooth removal. Postoperative pain, mouth opening, and facial swelling will be assessed preoperatively and on the first and seventh postoperative days.
The findings of this study may help determine whether PRF improves postoperative recovery following mandibular third molar surgery.
Detailed description
Impacted mandibular third molars frequently require surgical removal and represent one of the most commonly performed procedures in oral and maxillofacial surgery. Postoperative complications such as pain, facial swelling, and trismus commonly occur following surgical extraction and may negatively affect oral function and quality of life.
Various approaches have been proposed to reduce postoperative morbidity, including nonsteroidal anti-inflammatory drugs, corticosteroids, cold therapy, hyaluronic acid, and other adjunctive methods. Platelet-rich fibrin (PRF) is a second-generation autologous platelet concentrate that contains a fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors. These biological mediators contribute to angiogenesis, tissue regeneration, collagen synthesis, and wound healing.
The purpose of this randomized controlled trial is to evaluate the effects of platelet-rich fibrin on postoperative pain, trismus, and facial swelling following surgical removal of mandibular third molars.
Eligible participants aged 18 to 50 years with impacted mandibular third molars fulfilling the inclusion criteria will be recruited from the Department of Oral and Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. After obtaining written informed consent, participants will be randomly assigned to one of two groups:
PRF group: Platelet-rich fibrin will be prepared from the patient's venous blood and placed into the extraction socket before wound closure.
Control group: Sterile absorbable gelatin sponge (Gelfoam) will be placed into the extraction socket before wound closure.
Standardized surgical procedures, local anesthesia, medications, and postoperative instructions will be provided to all participants.
Outcome measures will include:
Postoperative pain assessed using the Visual Analog Scale (VAS). Trismus assessed by maximum interincisal opening measured in millimeters. Facial swelling assessed using standardized facial measurements. Measurements will be recorded preoperatively and on postoperative days 1 and 7.
The primary outcomes are postoperative pain and trismus, while facial swelling is considered a secondary outcome. Statistical analysis will compare outcomes between the two groups to determine whether PRF improves postoperative recovery after mandibular third molar surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive platelet-rich fibrin (PRF) placed in the extraction socket following mandibular third molar surgery, while the control group will receive sterile absorbable gelatin sponge (Gelfoam). Outcomes will be assessed preoperatively and on postoperative days 1 and 7.
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Fibrin (PRF) Group | Experimental | Biological: Platelet-rich fibrin (PRF)Participants undergoing surgical removal of impacted mandibular third molars will receive platelet-rich fibrin (PRF) prepared from autologous venous blood and placed into the extraction socket before wound closure. Standard postoperative medications and instructions will be provided. |
| Gelfoam Control Group | Active comparator | Device: Sterile Absorbable Gelatin SpongeParticipants undergoing surgical removal of impacted mandibular third molars will receive sterile absorbable gelatin sponge (Gelfoam) placed into the extraction socket before wound closure. Standard postoperative medications and instructions will be provided. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18 to 50 years Patients with impacted mandibular third molars indicated for surgical extraction Mesioangular or vertical impactions (Winter classification) Class II or Class III impactions, Position B or C (Pell and Gregory classification) Patients who provide written informed consent
Key exclusion criteria (1 listed)
- Pregnant or lactating females Patients with systemic diseases affecting healing (e.g., uncontrolled diabetes, immunocompromised states) Smokers Patients on medications affecting bone or soft tissue healing Patients with acute infection at the surgical site
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 |
|---|---|---|
| Platelet-rich fibrin (PRF)Platelet-rich fibrin (PRF) will be prepared from 10 mL of autologous venous blood collected from the participant. The blood sample will be centrifuged at 2700 rpm for 12 minutes to obtain the fibrin clot. Following surgical extraction of the mandibular third molar, the PRF clot will be placed into the extraction socket before wound closure. | Biological | Platelet-Rich Fibrin (PRF) Group |
| Sterile Absorbable Gelatin SpongeFollowing surgical extraction of the mandibular third molar, a sterile absorbable gelatin sponge (Gelfoam) will be placed into the extraction socket before wound closure. Standard postoperative medications and instructions will be provided to all participants. | Device | Gelfoam Control Group |
Primary outcome
Postoperative Pain
Time frame: Preoperative baseline, postoperative day 1, and postoperative day 7
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded and compared between the platelet-rich fibrin and Gelfoam groups.
Postoperative Trismus
Time frame: Preoperative baseline, postoperative day 1, and postoperative day 7
Trismus will be assessed by measuring the maximum interincisal opening in millimeters using a vernier caliper. The distance between the upper and lower central incisors at maximum mouth opening will be recorded and compared between the study groups.
Postoperative Facial Swelling (Edema)
Time frame: Preoperative baseline, postoperative day 1, and postoperative day 7
Facial swelling will be assessed using linear facial measurements taken with a measuring tape. Measurements will include the distance between the angle of the mandible and lateral canthus of the eye, tragus to corner of the mouth, and tragus to soft tissue pogonion. The average of these measurements will be used to calculate facial dimension and assess postoperative edema. Values will be compared between the platelet-rich fibrin and Gelfoam groups.
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 29 Jun 2026.
- Individual participant dataSharing planned: No. Not required
Related trials for Impacted Mandibular Third Molar
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing
Active, not recruiting
Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
Facial Swelling, Tooth Position Anomalies
Recruiting
Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
Alveolar Bone Loss
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 Platelet-rich fibrin (PRF) and Sterile Absorbable Gelatin Sponge in people with Impacted Mandibular Third Molar and Postoperative Pain, run by PAEC General Hospital, Islamabad 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 1 inclusion and 1 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 29 Jun 2026. 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?
Postoperative Pain (time frame: Preoperative baseline, postoperative day 1, and postoperative day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.