Alveolar OsteitisNCT06761001
Investigation of the Effect of I-PRF Application on Pain in Alveolitis
A study testing I-PRF in people with Alveolar Osteitis and Pain, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Literature review showed that there are no studies on the use of i-PRF in alveolitis cases. The aim of this study was to investigate the effect of i-PRF on the treatment of alveolitis. The hypothesis of the study was that i-PRF applied to alveolitis patients would reduce pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis, Pain, Dry Socket
- What is being tested?
- I-PRF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2024to 18 Feb 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals without systemic disease Patients with complete data and attending their appointments
Who cannot join
- Patients who smoke Pregnant or breastfeeding female patients with bleeding disorders and diabetics Patients currently or previously using bisphosphonates or receiving radiotherapy to the jaw Patients unable to consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University
Eskişehir, 26480
About this study
Literature review showed that there are no studies on the use of i-PRF in alveolitis cases. The aim of this study was to investigate the effect of i-PRF on the treatment of alveolitis. The hypothesis of the study was that i-PRF applied to alveolitis patients would reduce pain.
Read the detailed description
The present study will include 60 healthy patients over 18 years of age with alveolitis. 60 patients will be randomly divided into two groups: Control and I-PRF. After irrigation of the sockets, no substance will be applied to the control group, and I-PRF will be applied to the study group. Postoperative pain will be measured on the 3rd and 7th days.
- Conditions
- Alveolar Osteitis, Pain, Dry Socket
- Being tested
- I-PRF, Control
- Keywords
- injectable platelet rich fibrine
- Medical subject headings
- Dry Socket, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PRFDevice
After local anesthesia is injected, alveolar curettage is performed and the socket is irrigated with saline solution. I-PRF is given to patients in the experimental group.
ControlOther
After local anesthesia is injected, alveolar curettage is performed and the socket is irrigated with saline solution.
| Study group | Role | What they receive |
|---|---|---|
| I-PRF | Experimental | I-PRF Application Receives: Device: I-PRF |
| Standard treatment | Active comparator | standard treatment Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-operative pain assessed: visual analog (VAS) scale
VAS measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain
Measured: postoperative 3rd, and 7th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 Oct 2024
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alveolar OsteitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gorkem Tekin, Eskisehir Osmangazi University
- Investigators
- Görkem TEKİN, Assist.Prof., Study chair, Eskişehir Osmangazi University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761001
- Sponsor's protocol ID
- EskisehirOU-TEKIN-001
- Status last verified
- Feb 2025
- First submitted
- 30 Dec 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may share with other researchers upon request
Publications
Uranbey O, Ayranci F. How effective are concentrated growth factor and injectable platelets in reducing complications following impacted third molar surgery? Quintessence Int. 2024 May 30;55(5):380-390. doi: 10.3290/j.qi.b5213477.
PubMed 38619256Laforgia A, Inchingolo AD, Riccaldo L, Avantario P, Buongiorno S, Malcangi G, Bordea IR, Palermo A, Inchingolo F, Inchingolo AM, Dipalma G. The Use of Platelet-Rich Fibrin (PRF) in the Management of Dry Socket: A Systematic Review. Int J Mol Sci. 2024 Sep 19;25(18):10069. doi: 10.3390/ijms251810069.
PubMed 39337554Sharma A, Aggarwal N, Rastogi S, Choudhury R, Tripathi S. Effectiveness of platelet-rich fibrin in the management of pain and delayed wound healing associated with established alveolar osteitis (dry socket). Eur J Dent. 2017 Oct-Dec;11(4):508-513. doi: 10.4103/ejd.ejd_346_16.
PubMed 29279679Tekin G, Turedi SO. Is injectable platelet-rich fibrin really effective in alveolar osteitis? a randomised controlled clinical trial. BMC Oral Health. 2025 May 26;25(1):804. doi: 10.1186/s12903-025-06257-y.
PubMed 40420265
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of I-PRF Application on Pain in Alveolitis
- ClinicalTrials.gov ID
- NCT06761001
- Acronym / sponsor ID
- EskisehirOU-TEKIN-001
- Conditions
- Alveolar Osteitis, Pain, Dry Socket
- Keywords
- injectable platelet rich fibrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 7 Jan 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.
Literature review showed that there are no studies on the use of i-PRF in alveolitis cases. The aim of this study was to investigate the effect of i-PRF on the treatment of alveolitis. The hypothesis of the study was that i-PRF applied to alveolitis patients would reduce pain.
Detailed description
The present study will include 60 healthy patients over 18 years of age with alveolitis. 60 patients will be randomly divided into two groups: Control and I-PRF. After irrigation of the sockets, no substance will be applied to the control group, and I-PRF will be applied to the study group. Postoperative pain will be measured on the 3rd and 7th days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-PRF | Experimental | Device: I-PRFI-PRF Application |
| Standard treatment | Active comparator | Other: Controlstandard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy individuals without systemic disease Patients with complete data and attending their appointments
Key exclusion criteria (1 listed)
- Patients who smoke Pregnant or breastfeeding female patients with bleeding disorders and diabetics Patients currently or previously using bisphosphonates or receiving radiotherapy to the jaw Patients unable to consent to participate in the study
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 |
|---|---|---|
| I-PRFAfter local anesthesia is injected, alveolar curettage is performed and the socket is irrigated with saline solution. I-PRF is given to patients in the experimental group. | Device | I-PRF |
| ControlAfter local anesthesia is injected, alveolar curettage is performed and the socket is irrigated with saline solution. | Other | Standard treatment |
Primary outcome
Change in post-operative pain assessed: visual analog (VAS) scale
Time frame: postoperative 3rd, and 7th days
VAS measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain
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 19 Feb 2025.
- Results publication: PubMed 38619256Uranbey O, Ayranci F. How effective are concentrated growth factor and injectable platelets in reducing complications following impacted third molar surgery? Quintessence Int. 2024 May 30;55(5):380-390. doi: 10.3290/j.qi.b5213477.
- Results publication: PubMed 39337554Laforgia A, Inchingolo AD, Riccaldo L, Avantario P, Buongiorno S, Malcangi G, Bordea IR, Palermo A, Inchingolo F, Inchingolo AM, Dipalma G. The Use of Platelet-Rich Fibrin (PRF) in the Management of Dry Socket: A Systematic Review. Int J Mol Sci. 2024 Sep 19;25(18):10069. doi: 10.3390/ijms251810069.
- Results publication: PubMed 29279679Sharma A, Aggarwal N, Rastogi S, Choudhury R, Tripathi S. Effectiveness of platelet-rich fibrin in the management of pain and delayed wound healing associated with established alveolar osteitis (dry socket). Eur J Dent. 2017 Oct-Dec;11(4):508-513. doi: 10.4103/ejd.ejd_346_16.
- Derived from this study: PubMed 40420265Tekin G, Turedi SO. Is injectable platelet-rich fibrin really effective in alveolar osteitis? a randomised controlled clinical trial. BMC Oral Health. 2025 May 26;25(1):804. doi: 10.1186/s12903-025-06257-y.
- Individual participant dataSharing planned: No. IPD may share with other researchers upon request
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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.
Görkem TEKİN, Assist.Prof. study chair
Eskişehir Osmangazi 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 I-PRF in people with Alveolar Osteitis and Pain, run by Eskisehir Osmangazi 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 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 19 Feb 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?
Change in post-operative pain assessed: visual analog (VAS) scale (time frame: postoperative 3rd, and 7th days). 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 NCT06761001, which also lists 4 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 19 Feb 2025.