OsteoarthritisNCT04810923
Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis
A study testing i-PRF and Arthrocentesis in people with Osteoarthritis, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with temporomandibular joint osteoarthritis (TMJ-OA) randomly assigned one of the two treatment groups: intra-articular injection of injectable platelet-rich fibrin… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- i-PRF and Arthrocentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2019to 2 Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with osteoarthritis (OA) of one or two temporomandibular joint (TMJ)
- maximum mouth opening less than 35 mm
- impeded protrusive and lateral movements
- localized pain of the affected joint
Who cannot join
- systemic or malignant diseases affecting TMJ-OA assessment
- previous invasive or surgical treatments of TMJ unrelated to OA
- edentulous patients
- pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, Faculty of Dentistry
Izmir, Bornova, 35040
About this study
Official title: Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis: A Randomized Controlled Clinical Trial
The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with temporomandibular joint osteoarthritis (TMJ-OA) randomly assigned one of the two treatment groups: intra-articular injection of injectable platelet-rich fibrin (i-PRF) after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.
Read the detailed description
The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with TMJ-OA randomly assigned one of the two treatment groups: intra-articular injection of i-PRF after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. All treatment procedures were completed by the same experienced surgeon under the local anesthesia. The procedure of arthrocentesis was performed using the standard technique and after arthrocentesis procedure, the i-PRF injection was performed in the test group.
The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.
- Conditions
- Osteoarthritis
- Being tested
- i-PRF, Arthrocentesis
- Keywords
- Osteoarthritis, injectable platelet-rich fibrin, Arthrocentesis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-PRFProcedure or surgery
intra-articular i-PRF injection after arthrocentesis
ArthrocentesisProcedure or surgery
Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.
| Study group | Role | What they receive |
|---|---|---|
| i-PRF group | Experimental | arthrocentesis procedure plus four consecutive intra-articular injection of i-PRF. Receives: Procedure: i-PRF |
| Control group | Experimental | arthrocentesis procedure alone. Receives: Procedure: Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain Level
Pain level was measured with a visual analog scale (VAS) before treatment, and at postoperative follow-up (1st, 2nd, 3rd, 6th and 12th month).
Measured: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Secondary outcomes (3)
Change of maximum mouth opening
Maximum mouth opening was assessed by measuring the distance between the incisal border of upper and lower central incisors
Measured: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Change of lateral movement
Lateral movement was measured from the labioincisal contact between upper central incisors to the same point of lower central incisors
Measured: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Change of protrusive movement
Protrusive movement was measured from the incisal border of upper central incisors to same point of lower central incisors
Measured: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start2 Apr 2019
- Primary completion2 Dec 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Işık, Ege University
- Investigators
- Gözde Işık, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810923
- Sponsor's protocol ID
- 19-11/47
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04810923
- Acronym / sponsor ID
- 19-11/47
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, injectable platelet-rich fibrin, Arthrocentesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 23 Mar 2021 (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 authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with temporomandibular joint osteoarthritis (TMJ-OA) randomly assigned one of the two treatment groups: intra-articular injection of injectable platelet-rich fibrin (i-PRF) after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.
Detailed description
The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with TMJ-OA randomly assigned one of the two treatment groups: intra-articular injection of i-PRF after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. All treatment procedures were completed by the same experienced surgeon under the local anesthesia. The procedure of arthrocentesis was performed using the standard technique and after arthrocentesis procedure, the i-PRF injection was performed in the test group.
The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-PRF group | Experimental | Procedure: i-PRFarthrocentesis procedure plus four consecutive intra-articular injection of i-PRF. |
| Control group | Experimental | Procedure: Arthrocentesisarthrocentesis procedure alone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with osteoarthritis (OA) of one or two temporomandibular joint (TMJ)
- maximum mouth opening less than 35 mm
- impeded protrusive and lateral movements
- localized pain of the affected joint
Key exclusion criteria (4 listed)
- systemic or malignant diseases affecting TMJ-OA assessment
- previous invasive or surgical treatments of TMJ unrelated to OA
- edentulous patients
- pregnancy
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-PRFintra-articular i-PRF injection after arthrocentesis | Procedure or surgery | i-PRF group |
| ArthrocentesisArthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint. | Procedure or surgery | Control group |
Primary outcome
Change of Pain Level
Time frame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Pain level was measured with a visual analog scale (VAS) before treatment, and at postoperative follow-up (1st, 2nd, 3rd, 6th and 12th month).
3 secondary outcomes
Change of maximum mouth opening
Time frame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Change of lateral movement
Time frame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Change of protrusive movement
Time frame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
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 23 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Gözde Işık principal investigator
Ege University
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 and Arthrocentesis in people with Osteoarthritis, run by Ege 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 4 inclusion and 4 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 23 Mar 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 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 of Pain Level (time frame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month). 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 23 Mar 2021.