Impacted Mandibular Third Molar ExtractionNCT07742826
Comparison of PRF and Corticosteroids in Impacted Third Molar Surgery
A study testing Platelet-rich fibrin (PRF), Dexamethasone and Amoxicillin/Clavulanic Acid in people with Impacted Mandibular Third Molar Extraction and Impacted Lower Third Molar, run by Final International University at 1 site in Cyprus.
Trial summary
This prospective, randomized interventional study aims to compare the postoperative effects of standard treatment (control), platelet-rich fibrin (PRF), and PRF combined with corticosteroid treatment in patients undergoing impacted mandibular third molar surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction, Impacted Lower Third Molar, Impacted Wisdom Tooth
- What is being tested?
- Platelet-rich fibrin (PRF), Dexamethasone and Amoxicillin/Clavulanic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 3 Sep 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older.
- Patients with good general health
- Patients with complete clinical and radiographic examination (panoramic radiograph/CBCT if applicable)
- Patients willing and able to attend all postoperative follow-up visits
Who cannot join
- Patients with systemic diseases that may impair wound healing (e.g., uncontrolled diabetes, immunodeficiency).
- Pregnant or breastfeeding women.
- Patients with acute infection, abscess, or pericoronitis at the surgical site.
- Patients with a history of allergy or contraindication to corticosteroids, local anesthetics, or prescribed medications.
- Patients using corticosteroids, anticoagulants, immunosuppressive drugs, or bisphosphonates.
- Patients with bleeding disorders.
- Patients with previous radiotherapy to the head and neck region.
- Patients unable or unwilling to comply with the study protocol or attend follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus1 site, 1 recruiting
- Recruiting
Final International University Faculty of Dentistry
Nicosia, 2323
Meliz Kneebone, DDS, +905338425731, meliz-95@hotmail.com
Meliz Kneebone, DDS
About this study
Official title: Comparison of Postoperative Effects of PRF and Corticosteroid Treatments in Impacted Third Molar Surgery
This prospective, randomized interventional study aims to compare the postoperative effects of standard treatment (control), platelet-rich fibrin (PRF), and PRF combined with corticosteroid treatment in patients undergoing impacted mandibular third molar surgery. A total of 60 participants will be randomly assigned to one of three treatment groups according to the study protocol. Postoperative pain, facial swelling, and trismus will be evaluated on postoperative days 1, 2, 3, and 7. The findings of this study are expected to provide evidence regarding the effectiveness of PRF alone and PRF combined with corticosteroid treatment in reducing postoperative complications following impacted mandibular third molar surgery.
- Conditions
- Impacted Mandibular Third Molar Extraction, Impacted Lower Third Molar, Impacted Wisdom Tooth
- Being tested
- Platelet-rich fibrin (PRF), Dexamethasone, Amoxicillin/Clavulanic Acid, Paracetamol, Chlorhexidine
- Keywords
- Third Molar Surgery, Impacted Third Molar, Platelet-Rich Fibrin, Corticosteroids, Postoperative Pain, Facial Swelling, Trismus, Oral Surgery, Postoperative Complications
- Medical subject headings
- Pain, Postoperative, Trismus, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Biological
Autologous platelet-rich fibrin (PRF) prepared from the participant's venous blood by centrifugation at 3000 rpm for 10 minutes, and then placed into the extraction socket immediately after impacted mandibular third molar surgery.
DexamethasoneDrug
Dexamethasone (8 mg/2 mL) administered as a single intramuscular injection immediately after impacted mandibular third molar surgery in addition to platelet-rich fibrin (PRF), according to the study protocol.
Amoxicillin/Clavulanic AcidDrug
Amoxicillin/clavulanic acid administered postoperatively according to the study protocol.
ParacetamolDrug
Paracetamol 500 mg tablets administered postoperatively for pain control according to the study protocol.
ChlorhexidineDrug
Chlorhexidine mouthwash administered postoperatively according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Standard Postoperative Treatment (Control) | Active comparator | Participants receive standard postoperative treatment following impacted mandibular third molar surgery, including amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash. No platelet-rich fibrin (PRF) or corticosteroid is administered. Receives: Drug: Amoxicillin/Clavulanic Acid; Drug: Paracetamol; Drug: Chlorhexidine |
| Platelet-Rich Fibrin (PRF) | Experimental | Participants receive platelet-rich fibrin (PRF) placed into the extraction socket in addition to standard postoperative treatment consisting of amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash following impacted mandibular third molar surgery. Receives: Biological: Platelet-rich fibrin (PRF); Drug: Amoxicillin/Clavulanic Acid; Drug: Paracetamol; Drug: Chlorhexidine |
| Platelet-Rich Fibrin Plus Corticosteroid | Experimental | Participants receive platelet-rich fibrin (PRF) placement into the extraction socket followed by intramuscular corticosteroid administration, in addition to standard postoperative treatment consisting of amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash following impacted mandibular third molar surgery. Receives: Biological: Platelet-rich fibrin (PRF); Drug: Dexamethasone; Drug: Amoxicillin/Clavulanic Acid; Drug: Paracetamol; Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: Postoperative Days 1, 2, 3, and 7
Postoperative Swelling
Postoperative facial swelling assessed using a flexible measuring tape by recording the linear distances from the tragus to the pogonion (chin point), the tragus to the corner of the mouth, and the lateral canthus of the eye to the angle of the mandible.
Measured: Postoperative Days 1, 2, 3, and 7
Trismus
Trismus assessed by measuring the maximum interincisal mouth opening (mm) using a digital caliper.
Measured: Postoperative Days 1, 2, 3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start3 Sep 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies 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 are randomly assigned by a simple randomization method (dice roll) to one of three parallel groups: a control group receiving standard treatment, a platelet-rich fibrin (PRF) group, or a PRF combined with corticosteroid group. Each participant receives only the intervention assigned at enrollment, and postoperative outcomes are compared between the groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Final International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meliz Kneebone, Final International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742826
- Sponsor's protocol ID
- Final International University
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study was conducted as part of an academic thesis, and there is no institutional plan for sharing de-identified participant-level data.
Publications
Donmezer CM, Bilginaylar K. Comparison of the Postoperative Effects of Local Antibiotic versus Systemic Antibiotic with the Use of Platelet-Rich Fibrin on Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Study. Biomed Res Int. 2021 Dec 2;2021:3040661. doi: 10.1155/2021/3040661. eCollection 2021.
PubMed 34901267Koc O, Er N, Karaca C, Bilginaylar K. Comparison of the effects of submucosal hyaluronidase and dexamethasone on postoperative edema, pain, trismus, and infection following impacted third molar surgery. BMC Oral Health. 2024 Aug 30;24(1):1018. doi: 10.1186/s12903-024-04729-1.
PubMed 39215323
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Effects of PRF and Corticosteroid Treatments in Impacted Third Molar Surgery
- ClinicalTrials.gov ID
- NCT07742826
- Acronym / sponsor ID
- Final International University
- Conditions
- Impacted Mandibular Third Molar Extraction, Impacted Lower Third Molar, Impacted Wisdom Tooth
- Keywords
- Third Molar Surgery, Impacted Third Molar, Platelet-Rich Fibrin, Corticosteroids, Postoperative Pain, Facial Swelling, Trismus, Oral Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Final International UniversityUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 Aug 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.
This prospective, randomized interventional study aims to compare the postoperative effects of standard treatment (control), platelet-rich fibrin (PRF), and PRF combined with corticosteroid treatment in patients undergoing impacted mandibular third molar surgery. A total of 60 participants will be randomly assigned to one of three treatment groups according to the study protocol. Postoperative pain, facial swelling, and trismus will be evaluated on postoperative days 1, 2, 3, and 7. The findings of this study are expected to provide evidence regarding the effectiveness of PRF alone and PRF combined with corticosteroid treatment in reducing postoperative complications following impacted mandibular third molar surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned by a simple randomization method (dice roll) to one of three parallel groups: a control group receiving standard treatment, a platelet-rich fibrin (PRF) group, or a PRF combined with corticosteroid group. Each participant receives only the intervention assigned at enrollment, and postoperative outcomes are compared between the groups.
| Arm | Type | Receives |
|---|---|---|
| Standard Postoperative Treatment (Control) | Active comparator | Drug: Amoxicillin/Clavulanic Acid, Drug: Paracetamol, Drug: ChlorhexidineParticipants receive standard postoperative treatment following impacted mandibular third molar surgery, including amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash. No platelet-rich fibrin (PRF) or corticosteroid is administered. |
| Platelet-Rich Fibrin (PRF) | Experimental | Biological: Platelet-rich fibrin (PRF), Drug: Amoxicillin/Clavulanic Acid, Drug: Paracetamol, Drug: ChlorhexidineParticipants receive platelet-rich fibrin (PRF) placed into the extraction socket in addition to standard postoperative treatment consisting of amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash following impacted mandibular third molar surgery. |
| Platelet-Rich Fibrin Plus Corticosteroid | Experimental | Biological: Platelet-rich fibrin (PRF), Drug: Dexamethasone, Drug: Amoxicillin/Clavulanic Acid, Drug: Paracetamol, Drug: ChlorhexidineParticipants receive platelet-rich fibrin (PRF) placement into the extraction socket followed by intramuscular corticosteroid administration, in addition to standard postoperative treatment consisting of amoxicillin/clavulanic acid (Augmentin), paracetamol, and chlorhexidine mouthwash following impacted mandibular third molar surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years and older.
- Patients with good general health
- Patients with complete clinical and radiographic examination (panoramic radiograph/CBCT if applicable)
- Patients willing and able to attend all postoperative follow-up visits
Key exclusion criteria (8 listed)
- Patients with systemic diseases that may impair wound healing (e.g., uncontrolled diabetes, immunodeficiency).
- Pregnant or breastfeeding women.
- Patients with acute infection, abscess, or pericoronitis at the surgical site.
- Patients with a history of allergy or contraindication to corticosteroids, local anesthetics, or prescribed medications.
- Patients using corticosteroids, anticoagulants, immunosuppressive drugs, or bisphosphonates.
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)Autologous platelet-rich fibrin (PRF) prepared from the participant's venous blood by centrifugation at 3000 rpm for 10 minutes, and then placed into the extraction socket immediately after impacted mandibular third molar surgery. | Biological | Platelet-Rich Fibrin (PRF), Platelet-Rich Fibrin Plus Corticosteroid |
| DexamethasoneDexamethasone (8 mg/2 mL) administered as a single intramuscular injection immediately after impacted mandibular third molar surgery in addition to platelet-rich fibrin (PRF), according to the study protocol. | Drug | Platelet-Rich Fibrin Plus Corticosteroid |
| Amoxicillin/Clavulanic AcidAmoxicillin/clavulanic acid administered postoperatively according to the study protocol. | Drug | Platelet-Rich Fibrin (PRF), Platelet-Rich Fibrin Plus Corticosteroid, Standard Postoperative Treatment (Control) |
| ParacetamolParacetamol 500 mg tablets administered postoperatively for pain control according to the study protocol. | Drug | Platelet-Rich Fibrin (PRF), Platelet-Rich Fibrin Plus Corticosteroid, Standard Postoperative Treatment (Control) |
| ChlorhexidineChlorhexidine mouthwash administered postoperatively according to the study protocol. | Drug | Platelet-Rich Fibrin (PRF), Platelet-Rich Fibrin Plus Corticosteroid, Standard Postoperative Treatment (Control) |
Primary outcome
Postoperative Pain
Time frame: Postoperative Days 1, 2, 3, and 7
Postoperative pain assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Postoperative Swelling
Time frame: Postoperative Days 1, 2, 3, and 7
Postoperative facial swelling assessed using a flexible measuring tape by recording the linear distances from the tragus to the pogonion (chin point), the tragus to the corner of the mouth, and the lateral canthus of the eye to the angle of the mandible.
Trismus
Time frame: Postoperative Days 1, 2, 3, and 7
Trismus assessed by measuring the maximum interincisal mouth opening (mm) using a digital caliper.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 34901267Donmezer CM, Bilginaylar K. Comparison of the Postoperative Effects of Local Antibiotic versus Systemic Antibiotic with the Use of Platelet-Rich Fibrin on Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Study. Biomed Res Int. 2021 Dec 2;2021:3040661. doi: 10.1155/2021/3040661. eCollection 2021.
- Background: PubMed 39215323Koc O, Er N, Karaca C, Bilginaylar K. Comparison of the effects of submucosal hyaluronidase and dexamethasone on postoperative edema, pain, trismus, and infection following impacted third molar surgery. BMC Oral Health. 2024 Aug 30;24(1):1018. doi: 10.1186/s12903-024-04729-1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study was conducted as part of an academic thesis, and there is no institutional plan for sharing de-identified participant-level data.
Related trials for Impacted Mandibular Third Molar Extraction
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
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
Not yet recruiting
Comparison of Electrocautery and Scalpel Blade Incisions of Impacted Mandibular Third Molars
Impacted Mandibular Third Molar
Recruiting
Regenerative Gel (Emdogain®) for Healing After Wisdom Tooth Extraction
Alveolar Bone Loss, Periodontal Pocket
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.
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), Dexamethasone and Amoxicillin/Clavulanic Acid in people with Impacted Mandibular Third Molar Extraction and Impacted Lower Third Molar, run by Final International University at 1 site in Cyprus.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Aug 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 Cyprus. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meliz Kneebone, DDS (+905338425731, meliz-95@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: Postoperative Days 1, 2, 3, and 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?
On the ClinicalTrials.gov record for NCT07742826, which also lists 2 linked publications.
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 3 Aug 2026.