Alveolar OsteitisNCT04476121
Use of PRF in Treatment of Dry Socket.
A study testing PRF application and Nipas application in people with Alveolar Osteitis, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of the study is to evaluate the influence of PRF application in case of alveolar osteitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis
- What is being tested?
- PRF application and Nipas application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2019to 1 Jul 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no known medical history of abnormal platelet counts,
- patients with symmetric teeth qualified for extraction,
Who cannot join
- patients treated previously for existing dry socket,
- patients allergic to acetylsalicylic acid ,
- systemic diseases,
- pregnancy,
- lactation,
- drugs known to affect the number or function of platelets,
- abnormal platelet counts,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Platelet Rich Fibrin Use in the Treatment of Dry Socket.
The aim of the study is to evaluate the influence of PRF application in case of alveolar osteitis.
Read the detailed description
The main objective was to compare the effects of using two different methods in the treatment of dry socket (alveolar osteitis), which is a postoperative complication of dental extraction. The first was Nipas, applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth and reoccurrence of dry socket, patients were treated with application of PRF.
- Conditions
- Alveolar Osteitis
- Being tested
- PRF application, Nipas application
- Keywords
- dry socket, PRF
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF applicationProcedure or surgery
PRF application into post-operative wound.
Nipas applicationDrug
Also called Aspirin paste
Nipas application into post-operative wound.
| Study group | Role | What they receive |
|---|---|---|
| PRF application | Experimental | Patients with alveolar osteitis in which PRF application was performed. Receives: Procedure: PRF application |
| Aspirin application | Active comparator | Patients with alveolar osteitis in which Nipas was used. Receives: Drug: Nipas application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain vs. PRF and Nipas application
In order to evaluate the relationship between intensity of pain after application of PRF and Nipas, Numeric Rating Scale pain scale is used. NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
The higher score means worse outcome in case of present study.
Measured: 24 hours
Influence of treatment on bacteria levels in wounds
The second part of the study was dedicated to analyzing the number of bacteria in tooth extraction wounds.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Jan 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first medicine was applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth in the same patient and reoccurrence of dry socket, patients were treated with PRF application.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Janas-Naze, Prof., Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476121
- Sponsor's protocol ID
- 0002
- Status last verified
- Jun 2020
- First submitted
- 15 Jul 2020
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet Rich Fibrin Use in the Treatment of Dry Socket.
- ClinicalTrials.gov ID
- NCT04476121
- Acronym / sponsor ID
- 0002
- Conditions
- Alveolar Osteitis
- Keywords
- dry socket, PRF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 17 Jul 2020 (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.
The aim of the study is to evaluate the influence of PRF application in case of alveolar osteitis.
Detailed description
The main objective was to compare the effects of using two different methods in the treatment of dry socket (alveolar osteitis), which is a postoperative complication of dental extraction. The first was Nipas, applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth and reoccurrence of dry socket, patients were treated with application of PRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first medicine was applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth in the same patient and reoccurrence of dry socket, patients were treated with PRF application.
| Arm | Type | Receives |
|---|---|---|
| PRF application | Experimental | Procedure: PRF applicationPatients with alveolar osteitis in which PRF application was performed. |
| Aspirin application | Active comparator | Drug: Nipas applicationPatients with alveolar osteitis in which Nipas was used. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- no known medical history of abnormal platelet counts,
- patients with symmetric teeth qualified for extraction,
Key exclusion criteria (7 listed)
- patients treated previously for existing dry socket,
- patients allergic to acetylsalicylic acid ,
- systemic diseases,
- pregnancy,
- lactation,
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 |
|---|---|---|
| PRF applicationPRF application into post-operative wound. | Procedure or surgery | PRF application |
| Nipas applicationAlso: Aspirin pasteNipas application into post-operative wound. | Drug | Aspirin application |
Primary outcome
Intensity of pain vs. PRF and Nipas application
Time frame: 24 hours
In order to evaluate the relationship between intensity of pain after application of PRF and Nipas, Numeric Rating Scale pain scale is used. NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. The higher score means worse outcome in case of present study.
Influence of treatment on bacteria levels in wounds
Time frame: 24 hours
The second part of the study was dedicated to analyzing the number of bacteria in tooth extraction wounds.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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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.
Anna Janas-Naze, Prof. principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF application and Nipas application in people with Alveolar Osteitis, run by Medical University of Lodz at 1 site in Poland.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. 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 Poland. 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?
Results are not available in the source record.
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?
Intensity of pain vs. PRF and Nipas application (time frame: 24 hours). The study lists 2 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 26 Apr 2021.