Healing Surgical WoundsNCT06328413
L-PRF vs PBM on Extraction Socket Healing
A study testing photobiomodulation and Leukocyte and Platelet Rich Fibrin in people with Healing Surgical Wounds and Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healing Surgical Wounds, Pain
- What is being tested?
- photobiomodulation and Leukocyte and Platelet Rich Fibrin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2020to 21 Sep 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Class-I healthy volunteers
- Between 18 and 40 years of age who had wisdom teeth (Pell and Gregory Class II, Position B) with bone retention in bilateral symmetrical position with an indication for extraction, and had second molars in the mouth,
- Not use steroids or anti-inflammatory drugs in the last 3 months.
Who cannot join
- Patients with pericoronitis,
- Smoking habits
- Active periodontal disease
- Pregnancy,
- Breastfeeding
- Unable to give personal consent, and those with missing physical examination and follow-up records were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Pain, Soft Tissue Healing and Density of Newly Formed Bone Tissue in Surgical Extraction Sockets After Leukocyte and Platelet Rich Fibrin and Photobiomodulation Applications
The aim of this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets.
Read the detailed description
After sample size calculation, healthy volunteers were included in the study. Both teeth of these individuals with bilaterally impacted wisdom teeth were extracted simultaneously. Photobiomodulation (PBM) or leukocyte and platelet rich fibrin (L-PRF), an autogenous blood product, was randomly applied to the right or left side extraction sockets. Volunteers were called for repeat sessions (days 2,4,7,7,11,11,14,18 and 21) for the PBM treated side. Follow-ups were performed for pain (days 2,4,7) and soft and bone tissue healing.
- Conditions
- Healing Surgical Wounds, Pain
- Being tested
- photobiomodulation, Leukocyte and Platelet Rich Fibrin
- Keywords
- photobiomodulation, L-PRF, pain, bone healing, soft tissue healing, third molar
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationDevice
Photobiomodulation application at different extraoral and intraoral points for 60 seconds with a wavelength of 940 nm in repeated sessions after the extraction of third molar
Leukocyte and Platelet Rich FibrinOther
Leukocyte and platelet rich fibrin ( blood product centrifuged for 12 minutes at 2700rpm) application after third molar extraction, single session.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation group | Experimental | Photobiomodulation application at different extra and intraoral points for 60 seconds with a wavelength of 940 nm in repeated sessions after the extraction of third molar Receives: Device: photobiomodulation |
| Leukocyte and platelet-rich fibrin group | Active comparator | Leukocyte and platelet rich fibrin ( blood product centrifuged for 12 minutes at 2700rpm) application after third molar extraction, single session. Receives: Other: Leukocyte and Platelet Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newly formed bone (Healing at extraction sockets)
Newly formed bone assessed on Panoramic x-ray with Image J programme
Measured: Bone healing at the end of 1st and 3rd months after third molar extractions
Secondary outcomes (2)
Soft tissue healing
Landry Index scores (1: Very poor, 2: Poor, 3: Good, 4. Very Good, 5. Excellent healing)
Measured: End of 1st, 2nd week and 1st month after tooth extraction
Probing depth
Probing depth of second mandibular molar distal pocket (millimeters)
Measured: End of 1st, 2nd week and 1st month after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start20 Apr 2020
- Primary completion21 Jun 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healing Surgical WoundsStudies 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
- Since the groups were formed on the same individual, only which side would be the PBM and which side would be the L-PRF group was determined by coin-flip method (simple randomization).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cennet Neslihan Eroglu,DDS,PhD, Akdeniz University
- Investigators
- Cennet N Eroglu, DDS,PhD, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328413
- Sponsor's protocol ID
- KAEK-302
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Demirok SO, Eroglu CN, Koc A. Comprehensive analysis of bone tissue in extraction sockets of third molars after leukocyte and platelet rich fibrin and photobiomodulation applications. Clin Oral Investig. 2024 Aug 13;28(9):483. doi: 10.1007/s00784-024-05872-3.
PubMed 39136788
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Pain, Soft Tissue Healing and Density of Newly Formed Bone Tissue in Surgical Extraction Sockets After Leukocyte and Platelet Rich Fibrin and Photobiomodulation Applications
- ClinicalTrials.gov ID
- NCT06328413
- Acronym / sponsor ID
- KAEK-302
- Conditions
- Healing Surgical Wounds, Pain
- Keywords
- photobiomodulation, L-PRF, pain, bone healing, soft tissue healing, third molar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 25 Mar 2024 (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 this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets.
Detailed description
After sample size calculation, healthy volunteers were included in the study. Both teeth of these individuals with bilaterally impacted wisdom teeth were extracted simultaneously. Photobiomodulation (PBM) or leukocyte and platelet rich fibrin (L-PRF), an autogenous blood product, was randomly applied to the right or left side extraction sockets. Volunteers were called for repeat sessions (days 2,4,7,7,11,11,14,18 and 21) for the PBM treated side. Follow-ups were performed for pain (days 2,4,7) and soft and bone tissue healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Since the groups were formed on the same individual, only which side would be the PBM and which side would be the L-PRF group was determined by coin-flip method (simple randomization).
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group | Experimental | Device: photobiomodulationPhotobiomodulation application at different extra and intraoral points for 60 seconds with a wavelength of 940 nm in repeated sessions after the extraction of third molar |
| Leukocyte and platelet-rich fibrin group | Active comparator | Other: Leukocyte and Platelet Rich FibrinLeukocyte and platelet rich fibrin ( blood product centrifuged for 12 minutes at 2700rpm) application after third molar extraction, single session. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) Class-I healthy volunteers
- Between 18 and 40 years of age who had wisdom teeth (Pell and Gregory Class II, Position B) with bone retention in bilateral symmetrical position with an indication for extraction, and had second molars in the mouth,
- Not use steroids or anti-inflammatory drugs in the last 3 months.
Key exclusion criteria (6 listed)
- Patients with pericoronitis,
- Smoking habits
- Active periodontal disease
- Pregnancy,
- Breastfeeding
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 |
|---|---|---|
| photobiomodulationPhotobiomodulation application at different extraoral and intraoral points for 60 seconds with a wavelength of 940 nm in repeated sessions after the extraction of third molar | Device | Photobiomodulation group |
| Leukocyte and Platelet Rich FibrinLeukocyte and platelet rich fibrin ( blood product centrifuged for 12 minutes at 2700rpm) application after third molar extraction, single session. | Other | Leukocyte and platelet-rich fibrin group |
Primary outcome
Newly formed bone (Healing at extraction sockets)
Time frame: Bone healing at the end of 1st and 3rd months after third molar extractions
Newly formed bone assessed on Panoramic x-ray with Image J programme
2 secondary outcomes
Soft tissue healing
Time frame: End of 1st, 2nd week and 1st month after tooth extraction
Probing depth
Time frame: End of 1st, 2nd week and 1st month after tooth extraction
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 25 Mar 2024.
- Derived from this study: PubMed 39136788Demirok SO, Eroglu CN, Koc A. Comprehensive analysis of bone tissue in extraction sockets of third molars after leukocyte and platelet rich fibrin and photobiomodulation applications. Clin Oral Investig. 2024 Aug 13;28(9):483. doi: 10.1007/s00784-024-05872-3.
- 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.
Cennet N Eroglu, DDS,PhD principal investigator
Akdeniz 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 photobiomodulation and Leukocyte and Platelet Rich Fibrin in people with Healing Surgical Wounds and Pain, run by Akdeniz 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 6 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 25 Mar 2024. 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?
Newly formed bone (Healing at extraction sockets) (time frame: Bone healing at the end of 1st and 3rd months after third molar extractions). 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 NCT06328413, which also lists 1 linked publication.
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 25 Mar 2024.