Disc DisorderNCT05640206
Effect of Injectable Platelet-rich Fibrin on Disc Displacement Without Reduction
A study testing i-PRF and Arthrocentesis in people with Disc Disorder, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + injectable platelet-rich fibrin (i-PRF). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disc Disorder
- 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
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unilateral or bilateral disc displacement without reduction
- localized pain on temporomandibular joint
- decreased mouth opening, lateral and protrusive movements
Who cannot join
- Malignant or inflammatory disorders
- prior surgical history of temporomandibular joint
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Dentistry
Izmir, Bornova, 35100
About this study
Official title: Effect of Intra-articular Injection of Injectable Platelet-rich Fibrin on Disc Displacement Without Reduction
This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + injectable platelet-rich fibrin (i-PRF). As primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.
Read the detailed description
This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + i-PRF. Arthrocentesis procedure was performed for all groups with two needle technique. For test group, intra-articular i-PRF was made. As a primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.
- Conditions
- Disc Disorder
- Being tested
- i-PRF, Arthrocentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-PRFProcedure or surgery
Arthrocentesis performed with two-needle technique, and then injection of i-PRF intra-articularly
ArthrocentesisProcedure or surgery
Arthrocentesis performed with two-needle technique
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | intra-articular i-PRF injection after arthrocentesis Receives: Procedure: i-PRF |
| Control group | Experimental | only arthrocentesis Receives: Procedure: Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain
Pain was measured with a 10-point visual analogue scale which range from 0 meaning no pain to 10 meaning worst pain at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively
Measured: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Secondary outcomes (3)
Change of maximum mouth opening
Maximum mouth opening was measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively
Measured: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Change of lateral movements
Lateral movements were measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively
Measured: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Change of protrusive movements
Protrusive movements were measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively
Measured: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Oct 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc DisorderStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 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
- NCT05640206
- Sponsor's protocol ID
- 22038
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2022
- Last updated
- 8 Dec 2022
- 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 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra-articular Injection of Injectable Platelet-rich Fibrin on Disc Displacement Without Reduction
- ClinicalTrials.gov ID
- NCT05640206
- Acronym / sponsor ID
- 22038
- Conditions
- Disc Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 7 Dec 2022 (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 randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + injectable platelet-rich fibrin (i-PRF). As primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.
Detailed description
This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + i-PRF. Arthrocentesis procedure was performed for all groups with two needle technique. For test group, intra-articular i-PRF was made. As a primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: i-PRFintra-articular i-PRF injection after arthrocentesis |
| Control group | Experimental | Procedure: Arthrocentesisonly arthrocentesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unilateral or bilateral disc displacement without reduction
- localized pain on temporomandibular joint
- decreased mouth opening, lateral and protrusive movements
Key exclusion criteria (2 listed)
- Malignant or inflammatory disorders
- prior surgical history of temporomandibular joint
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-PRFArthrocentesis performed with two-needle technique, and then injection of i-PRF intra-articularly | Procedure or surgery | Test group |
| ArthrocentesisArthrocentesis performed with two-needle technique | Procedure or surgery | Control group |
Primary outcome
Change of pain
Time frame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Pain was measured with a 10-point visual analogue scale which range from 0 meaning no pain to 10 meaning worst pain at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively
3 secondary outcomes
Change of maximum mouth opening
Time frame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Change of lateral movements
Time frame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
Change of protrusive movements
Time frame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively
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 8 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Disc Disorder
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
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 Disc Disorder, 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 3 inclusion and 2 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 8 Dec 2022. 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 (time frame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively). 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 8 Dec 2022.