Impacted Mandibular Third MolarDEXPRF-3MNCT07045350
Dexamethasone-PRF in Mandibular Third Molar Surgery: Effect on Pain, Edema, and Trismus (DEXPRF-3M)
A study testing Platelet-rich fibrin (PRF) in people with Impacted Mandibular Third Molar, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary This clinical trial investigates the effects of platelet-rich fibrin (PRF) derived from dexamethasone-enriched blood on postoperative recovery following the surgical extraction of impacted mandibular third molars (wisdom teeth). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Mandibular Third Molar
- What is being tested?
- Platelet-rich fibrin (PRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 23 Jul 2024
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 and 25 years.
- Presence of bilateral, symmetrical, bone-retained impacted mandibular third molars requiring extraction.
- Systemically healthy individuals with no chronic medical conditions.
- Good oral hygiene and healthy periodontal status.
- Radiographically confirmed bilateral similarity of impacted third molars.
- Patients willing to participate and who provided written informed consent.
Who cannot join
- Presence of systemic diseases or conditions that may affect wound healing.
- Regular use of prescription medications.
- Pregnant or lactating individuals, or those with suspected pregnancy.
- Known allergy or hypersensitivity to dexamethasone or related compounds.
- Poor oral hygiene or active periodontal disease.
- Presence of fungal, viral, or bacterial infection either systemically or locally.
- History of corticosteroid use within the past month.
- Temporomandibular joint disorders affecting mouth opening.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Sivas, 58140
About this study
Official title: Evaluation of the Effects of Dexamethasone-Enriched Platelet-Rich Fibrin on Postoperative Pain, Edema, and Trismus Following Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
Brief Summary
This clinical trial investigates the effects of platelet-rich fibrin (PRF) derived from dexamethasone-enriched blood on postoperative recovery following the surgical extraction of impacted mandibular third molars (wisdom teeth). The study aims to determine whether the addition of dexamethasone, a potent anti-inflammatory medication, to the blood used for PRF preparation can reduce postoperative pain, swelling, and limited mouth opening (trismus) more effectively than standard PRF.
Read more
The study is designed as a randomized, split-mouth, double-blind clinical trial involving 16 patients who require bilateral extraction of impacted lower third molars. Each patient receives both treatments: one extraction socket treated with standard PRF and the other with dexamethasone-enriched PRF. Postoperative outcomes including pain intensity, edema, trismus, and analgesic consumption are recorded and analyzed.
The results of this study could offer a safer and more effective method for managing discomfort after wisdom tooth removal, potentially improving patient quality of life and reducing the need for additional medications.
Read the detailed description
Detailed Description
Background:
Third molar (wisdom tooth) extraction is a common oral surgical procedure often associated with postoperative inflammatory complications such as pain, edema, and trismus, which can significantly reduce patient quality of life. Platelet-rich fibrin (PRF) has been used to enhance healing and reduce postoperative morbidity. Dexamethasone is a corticosteroid known for its potent anti-inflammatory effects. This study evaluates whether PRF prepared from dexamethasone-enriched blood can improve postoperative outcomes compared to standard PRF.
Objectives:
The primary objective is to assess the effect of dexamethasone-enriched PRF on postoperative pain following impacted mandibular third molar extraction. Secondary objectives include evaluation of edema, trismus, and analgesic consumption.
Study Design:
This is a randomized, controlled, split-mouth, double-blind clinical trial conducted in a single center. Sixteen patients with bilateral symmetrical impacted mandibular third molars requiring extraction were enrolled. Each patient received two different treatments: one socket treated with standard PRF and the contralateral socket treated with dexamethasone-enriched PRF.
Participants:
Eligible patients were aged 18-25 years, in good systemic health, with no contraindications for oral surgery or corticosteroid use. Exclusion criteria included systemic diseases, pregnancy or lactation, hypersensitivity to corticosteroids, poor oral hygiene, recent corticosteroid therapy, and temporomandibular joint disorders.
Intervention:
Peripheral venous blood was drawn from each patient, with dexamethasone added to one sample prior to centrifugation to prepare the test PRF. The control PRF was prepared without dexamethasone. PRF clots were applied immediately into the extraction sockets after tooth removal.
Outcome Measures:
Postoperative pain was measured using a visual analog scale (VAS) at 24, 48, and 72 hours. Edema and trismus were evaluated on postoperative days 1, 3, and 7. Analgesic intake was recorded throughout the postoperative period. Data were analyzed with appropriate statistical tests considering p < 0.05 as significant.
Ethical Considerations:
The study was approved by the institutional ethics committee (approval number XXXX), and written informed consent was obtained from all participants. The study complied with the Declaration of Helsinki guidelines.
Significance:
Findings from this study may provide evidence for a novel, autologous drug delivery method to reduce postoperative morbidity after mandibular third molar surgery, potentially improving patient comfort and clinical outcomes.
- Conditions
- Impacted Mandibular Third Molar
- Being tested
- Platelet-rich fibrin (PRF)
- Keywords
- Third molar, Platelet Rich Fibrin, Dexamethasone, Edema, Pain, Trismus
- Medical subject headings
- Edema, Pain, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Procedure or surgery
Also called Dexamethasone-Enriched Platelet-Rich Fibrin
Application of autologous platelet-rich fibrin (PRF) prepared from peripheral blood with or without the addition of 4 mg dexamethasone directly into the blood collection tube prior to centrifugation. PRF was applied into the extraction socket after impacted mandibular third molar surgery. The test group received PRF prepared from blood enriched with dexamethasone, while the control group received standard PRF without dexamethasone, to evaluate postoperative pain, edema, and trismus.
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard PRF | Active comparator | Application of standard platelet-rich fibrin (PRF) prepared from blood without dexamethasone to the mandibular third molar extraction site. Receives: Procedure: Platelet-rich fibrin (PRF) |
| Test - Dexamethasone-enriched PRF | Experimental | Application of platelet-rich fibrin (PRF) prepared from blood enriched with 4 mg dexamethasone to the mandibular third molar extraction site. Receives: Procedure: Platelet-rich fibrin (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain and Analgesic Consumption
Measurement of postoperative pain using the Visual Analog Scale (VAS; range 0-10, where 0 indicates no pain and 10 indicates the worst imaginable pain) and total analgesic intake at 24, 48, and 72 hours after mandibular third molar extraction.
Measured: 72 hours post-surgery
Secondary outcomes (2)
Postoperative Facial Edema
Facial swelling will be evaluated by measuring linear distances between predefined facial landmarks (tragus-commissure, tragus-pogonion, lateral canthus-gonion) on postoperative days 1, 3, and 7.
Measured: Postoperative days 1, 3, and 7
Postoperative Trismus
Maximum interincisal mouth opening (in millimeters) will be measured preoperatively and on postoperative days 1, 3, and 7 using a digital caliper to assess trismus severity.
Measured: Postoperative days 1, 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 posted1 Jul 2025
- Study start20 Jul 2023
- Primary completion25 Apr 2024
- Study completion23 Jul 2024
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
- Crossover
- Model description
- This randomized controlled clinical trial uses a split-mouth design, where each patient serves as their own control. One side receives platelet-rich fibrin (PRF) from dexamethasone-enriched blood, while the contralateral side receives standard PRF to compare postoperative outcomes.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Caner Dere, Cumhuriyet University
- Investigators
- Muhammet Caner Dere, DDS, Principal investigator, Sivas Cumhuriyet University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045350
- Sponsor's protocol ID
- SCU-EC-No: 2023-07/02
- Other IDs
- DIS-2024-328
- Acronym
- DEXPRF-3M
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study will be available upon request from the corresponding author (Dr. Muhammet Caner Dere, caner\_1995@hotmail.com). The shared data will include anonymized individual participant data related to postoperative pain, edema, trismus, and analgesic use. Data will be available after study completion and publication, for a period of 5 years. The data will be shared for scientific research and meta-analyses, subject to ethics committee approval and a data use agreement. Participants' informed consent included agreement for anonymized data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Dexamethasone-Enriched Platelet-Rich Fibrin on Postoperative Pain, Edema, and Trismus Following Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07045350
- Acronym / sponsor ID
- DEXPRF-3M / SCU-EC-No: 2023-07/02
- Conditions
- Impacted Mandibular Third Molar
- Keywords
- Third molar, Platelet Rich Fibrin, Dexamethasone, Edema, Pain, Trismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 1 Jul 2025 (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.
Brief Summary
This clinical trial investigates the effects of platelet-rich fibrin (PRF) derived from dexamethasone-enriched blood on postoperative recovery following the surgical extraction of impacted mandibular third molars (wisdom teeth). The study aims to determine whether the addition of dexamethasone, a potent anti-inflammatory medication, to the blood used for PRF preparation can reduce postoperative pain, swelling, and limited mouth opening (trismus) more effectively than standard PRF.
The study is designed as a randomized, split-mouth, double-blind clinical trial involving 16 patients who require bilateral extraction of impacted lower third molars. Each patient receives both treatments: one extraction socket treated with standard PRF and the other with dexamethasone-enriched PRF. Postoperative outcomes including pain intensity, edema, trismus, and analgesic consumption are recorded and analyzed.
The results of this study could offer a safer and more effective method for managing discomfort after wisdom tooth removal, potentially improving patient quality of life and reducing the need for additional medications.
Detailed description
Detailed Description
Background:
Third molar (wisdom tooth) extraction is a common oral surgical procedure often associated with postoperative inflammatory complications such as pain, edema, and trismus, which can significantly reduce patient quality of life. Platelet-rich fibrin (PRF) has been used to enhance healing and reduce postoperative morbidity. Dexamethasone is a corticosteroid known for its potent anti-inflammatory effects. This study evaluates whether PRF prepared from dexamethasone-enriched blood can improve postoperative outcomes compared to standard PRF.
Objectives:
The primary objective is to assess the effect of dexamethasone-enriched PRF on postoperative pain following impacted mandibular third molar extraction. Secondary objectives include evaluation of edema, trismus, and analgesic consumption.
Study Design:
This is a randomized, controlled, split-mouth, double-blind clinical trial conducted in a single center. Sixteen patients with bilateral symmetrical impacted mandibular third molars requiring extraction were enrolled. Each patient received two different treatments: one socket treated with standard PRF and the contralateral socket treated with dexamethasone-enriched PRF.
Participants:
Eligible patients were aged 18-25 years, in good systemic health, with no contraindications for oral surgery or corticosteroid use. Exclusion criteria included systemic diseases, pregnancy or lactation, hypersensitivity to corticosteroids, poor oral hygiene, recent corticosteroid therapy, and temporomandibular joint disorders.
Intervention:
Peripheral venous blood was drawn from each patient, with dexamethasone added to one sample prior to centrifugation to prepare the test PRF. The control PRF was prepared without dexamethasone. PRF clots were applied immediately into the extraction sockets after tooth removal.
Outcome Measures:
Postoperative pain was measured using a visual analog scale (VAS) at 24, 48, and 72 hours. Edema and trismus were evaluated on postoperative days 1, 3, and 7. Analgesic intake was recorded throughout the postoperative period. Data were analyzed with appropriate statistical tests considering p < 0.05 as significant.
Ethical Considerations:
The study was approved by the institutional ethics committee (approval number XXXX), and written informed consent was obtained from all participants. The study complied with the Declaration of Helsinki guidelines.
Significance:
Findings from this study may provide evidence for a novel, autologous drug delivery method to reduce postoperative morbidity after mandibular third molar surgery, potentially improving patient comfort and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized controlled clinical trial uses a split-mouth design, where each patient serves as their own control. One side receives platelet-rich fibrin (PRF) from dexamethasone-enriched blood, while the contralateral side receives standard PRF to compare postoperative outcomes.
| Arm | Type | Receives |
|---|---|---|
| Control - Standard PRF | Active comparator | Procedure: Platelet-rich fibrin (PRF)Application of standard platelet-rich fibrin (PRF) prepared from blood without dexamethasone to the mandibular third molar extraction site. |
| Test - Dexamethasone-enriched PRF | Experimental | Procedure: Platelet-rich fibrin (PRF)Application of platelet-rich fibrin (PRF) prepared from blood enriched with 4 mg dexamethasone to the mandibular third molar extraction site. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged between 18 and 25 years.
- Presence of bilateral, symmetrical, bone-retained impacted mandibular third molars requiring extraction.
- Systemically healthy individuals with no chronic medical conditions.
- Good oral hygiene and healthy periodontal status.
- Radiographically confirmed bilateral similarity of impacted third molars.
Key exclusion criteria (8 listed)
- Presence of systemic diseases or conditions that may affect wound healing.
- Regular use of prescription medications.
- Pregnant or lactating individuals, or those with suspected pregnancy.
- Known allergy or hypersensitivity to dexamethasone or related compounds.
- Poor oral hygiene or active periodontal disease.
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)Also: Dexamethasone-Enriched Platelet-Rich FibrinApplication of autologous platelet-rich fibrin (PRF) prepared from peripheral blood with or without the addition of 4 mg dexamethasone directly into the blood collection tube prior to centrifugation. PRF was applied into the extraction socket after impacted mandibular third molar surgery. The test group received PRF prepared from blood enriched with dexamethasone, while the control group received standard PRF without dexamethasone, to evaluate postoperative pain, edema, and trismus. | Procedure or surgery | Control - Standard PRF, Test - Dexamethasone-enriched PRF |
Primary outcome
Postoperative Pain and Analgesic Consumption
Time frame: 72 hours post-surgery
Measurement of postoperative pain using the Visual Analog Scale (VAS; range 0-10, where 0 indicates no pain and 10 indicates the worst imaginable pain) and total analgesic intake at 24, 48, and 72 hours after mandibular third molar extraction.
2 secondary outcomes
Postoperative Facial Edema
Time frame: Postoperative days 1, 3, and 7
Postoperative Trismus
Time frame: Postoperative days 1, 3, and 7
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 1 Jul 2025.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study will be available upon request from the corresponding author (Dr. Muhammet Caner Dere, caner_1995@hotmail.com). The shared data will include anonymized individual participant data related to postoperative pain, edema, trismus, and analgesic use. Data will be available after study completion and publication, for a period of 5 years. The data will be shared for scientific research and meta-analyses, subject to ethics committee approval and a data use agreement. Participants' informed consent included agreement for anonymized data sharing.
Related trials for Impacted Mandibular Third Molar
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Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
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Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
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Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
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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.
Muhammet Caner Dere, DDS principal investigator
Sivas Cumhuriyet University, Faculty of Dentistry
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) in people with Impacted Mandibular Third Molar, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 1 Jul 2025. 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 Turkey (Türkiye). 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 and Analgesic Consumption (time frame: 72 hours post-surgery). 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 1 Jul 2025.