Stem CellNCT04641533
Effect of Dental Pulp Stem Cells and L-PRF After Impacted Third Molar Extraction
A study testing L-PRF + DPSC and L-PRF in people with Stem Cell and Third Molar, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the clinical and radiographic effectiveness of Leukocyte-Platelet Rich Fibrin (L-PRF) and L-PRF combined with dental pulp stem cell (DPSC) application to the extraction socket of mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stem Cell, Third Molar, Periodontal Pocket
- What is being tested?
- L-PRF + DPSC and L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2018to 11 Aug 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 and 30 years
- Bilateral impacted LM3 extraction surgeries requirement
Who cannot join
- Having clinical signs or symptoms of abscess or cellulitis formation
- Having a history of radiotherapy
- Having any systemic diseases interfering with wound healing and/or smokers
- Patients who had been diagnosed as periodontitis
- Patients who had LM2s with caries or restorations that have an unidentifiable cementoenamel junction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dental Pulp Stem Cells and L-PRF Placed Into the Extraction Sockets of Impacted Mandibular Third Molars on the Periodontal Status of Adjacent Second Molars: a Split Mouth Randomised Controlled Clinical Trial
The purpose of this study is to compare the clinical and radiographic effectiveness of Leukocyte-Platelet Rich Fibrin (L-PRF) and L-PRF combined with dental pulp stem cell (DPSC) application to the extraction socket of mandibular third molars.
Read the detailed description
Patients aged between 18 and 30 years, seeking for bilateral impacted LM3 extraction surgeries and meeting eligibility criteria were included to the study. At baseline right and left impacted third molars (LM3s) were randomly assigned to one of the treatment group (L-PRF and L-PRF + DPSC). Baseline and 6th month clinical and radiographic measurements were compared.
- Conditions
- Stem Cell, Third Molar, Periodontal Pocket
- Being tested
- L-PRF + DPSC, L-PRF
- Keywords
- dental pulp, stem cell, third molar, Platelet-rich fibrin
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRF + DPSCProcedure or surgery
Also called Leukocyte platelet rich fibrin plus dental pulp stem cells
After surgical removal of impacted mandibular third molars, extraction sockets were filled with L-PRF membranes + DPSCs.
L-PRFProcedure or surgery
Also called Leukocyte platelet rich fibrin
After surgical removal of impacted contralateral mandibular third molars, each extraction sockets were only filled with L-PRF membranes.
| Study group | Role | What they receive |
|---|---|---|
| L-PRF + DPSC | Experimental | Mandibular third molars were extracted and DPSC with L-PRF placed into the socket. Receives: Procedure: L-PRF + DPSC |
| L-PRF | Active comparator | Mandibular third molars were extracted and L-PRF placed into the socket Receives: Procedure: L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket Depth (PPD)
Probing pocket Depth (PPD) is the distance between gingival margin and bottom of the periodontal pocket in mm.
Measured: 6 months
Clinical attachment level (CAL)
Clinical attachment level (CAL) is the distance between cemento-enamel junction and bottom of the periodontal pocket in mm.
Measured: 6 months
Secondary outcomes (4)
Radiographic vertical distance
The cementoenamel junction (CEJ) and the most coronal point of the alveolar bone were identified (AC) on the mesial and distal of lower second molars on digital panoramic radiographs. The vertical ruler on each digital image was used to calibrate the image and to convert measurements from pixels to millimeters with ImageJ. The vertical distance (VD) between cemento-enamel junction and alveolar crest of the lower second molar was than measured with "straight line" tool of the software. In order to calculate the real distance; ertical distance was divided to the magnification factor for panoramic image (1.2).
Measured: 6 months
Relative bone density (rBD)
For every extraction socket, a region of interest (ROI) is created for the socket region and one for the surrounding bone using the "Freehand Selection" tool of ImageJ software on panoramic radiographs. Mean grey values were recorded for each group and relative bone density (rBD) was calculated.
Measured: 6 months
Post-operative pain as assessed by visual analogue scale (VAS)
Self-reported pain measured in a 100 mm visual analogue scale (VAS) in which (0) denoted "no pain" and 100 meant "severe pain" was recorded at the end of the surgery and 7 days after extraction.
Measured: 7 days
Assessment of analgesic usage
The patients were asked to note the amount of analgesics within the post-operative 7 days.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start20 Jan 2018
- Primary completion10 Apr 2020
- Study completion11 Aug 2020
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 Stem CellStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective within person randomised split-mouth study. Left and right surgical sites for each participant were randomized using an online generated list to determine test and positive control LM3. (http://www.randomization.com). LM2s and LM3 extraction sockets were divided into two groups: a test group (extraction sockets filled with L-PRF membranes + DPSCs) and a control group (extraction sockets filled with L-PRF membranes).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Secil Cubuk, Baskent University
- Investigators
- Emine Alaaddinoğlu, Prof,PhD, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641533
- Sponsor's protocol ID
- SecilC
- Status last verified
- Nov 2020
- First submitted
- 16 Aug 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cubuk S, Oduncuoglu BF, Alaaddinoglu EE. The effect of dental pulp stem cells and L-PRF when placed into the extraction sockets of impacted mandibular third molars on the periodontal status of adjacent second molars: a split-mouth, randomized, controlled clinical trial. Oral Maxillofac Surg. 2023 Mar;27(1):59-68. doi: 10.1007/s10006-022-01045-2. Epub 2022 Feb 9.
PubMed 35141806
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dental Pulp Stem Cells and L-PRF Placed Into the Extraction Sockets of Impacted Mandibular Third Molars on the Periodontal Status of Adjacent Second Molars: a Split Mouth Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04641533
- Acronym / sponsor ID
- SecilC
- Conditions
- Stem Cell, Third Molar, Periodontal Pocket
- Keywords
- dental pulp, stem cell, third molar, Platelet-rich fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 24 Nov 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 purpose of this study is to compare the clinical and radiographic effectiveness of Leukocyte-Platelet Rich Fibrin (L-PRF) and L-PRF combined with dental pulp stem cell (DPSC) application to the extraction socket of mandibular third molars.
Detailed description
Patients aged between 18 and 30 years, seeking for bilateral impacted LM3 extraction surgeries and meeting eligibility criteria were included to the study. At baseline right and left impacted third molars (LM3s) were randomly assigned to one of the treatment group (L-PRF and L-PRF + DPSC). Baseline and 6th month clinical and radiographic measurements were compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective within person randomised split-mouth study. Left and right surgical sites for each participant were randomized using an online generated list to determine test and positive control LM3. (http://www.randomization.com). LM2s and LM3 extraction sockets were divided into two groups: a test group (extraction sockets filled with L-PRF membranes + DPSCs) and a control group (extraction sockets filled with L-PRF membranes).
| Arm | Type | Receives |
|---|---|---|
| L-PRF + DPSC | Experimental | Procedure: L-PRF + DPSCMandibular third molars were extracted and DPSC with L-PRF placed into the socket. |
| L-PRF | Active comparator | Procedure: L-PRFMandibular third molars were extracted and L-PRF placed into the socket |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged between 18 and 30 years
- Bilateral impacted LM3 extraction surgeries requirement
Key exclusion criteria (5 listed)
- Having clinical signs or symptoms of abscess or cellulitis formation
- Having a history of radiotherapy
- Having any systemic diseases interfering with wound healing and/or smokers
- Patients who had been diagnosed as periodontitis
- Patients who had LM2s with caries or restorations that have an unidentifiable cementoenamel junction
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 |
|---|---|---|
| L-PRF + DPSCAlso: Leukocyte platelet rich fibrin plus dental pulp stem cellsAfter surgical removal of impacted mandibular third molars, extraction sockets were filled with L-PRF membranes + DPSCs. | Procedure or surgery | L-PRF + DPSC |
| L-PRFAlso: Leukocyte platelet rich fibrinAfter surgical removal of impacted contralateral mandibular third molars, each extraction sockets were only filled with L-PRF membranes. | Procedure or surgery | L-PRF |
Primary outcome
Probing pocket Depth (PPD)
Time frame: 6 months
Probing pocket Depth (PPD) is the distance between gingival margin and bottom of the periodontal pocket in mm.
Clinical attachment level (CAL)
Time frame: 6 months
Clinical attachment level (CAL) is the distance between cemento-enamel junction and bottom of the periodontal pocket in mm.
4 secondary outcomes
Radiographic vertical distance
Time frame: 6 months
Relative bone density (rBD)
Time frame: 6 months
Post-operative pain as assessed by visual analogue scale (VAS)
Time frame: 7 days
Assessment of analgesic usage
Time frame: 7 days
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 24 Nov 2020.
- Derived from this study: PubMed 35141806Cubuk S, Oduncuoglu BF, Alaaddinoglu EE. The effect of dental pulp stem cells and L-PRF when placed into the extraction sockets of impacted mandibular third molars on the periodontal status of adjacent second molars: a split-mouth, randomized, controlled clinical trial. Oral Maxillofac Surg. 2023 Mar;27(1):59-68. doi: 10.1007/s10006-022-01045-2. Epub 2022 Feb 9.
- Individual participant dataSharing planned: No
Related trials for Stem Cell
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Idiopathic CD4-Positive, T-Lymphocytopenia
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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.
Emine Alaaddinoğlu, Prof,PhD study director
Baskent 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 L-PRF + DPSC and L-PRF in people with Stem Cell and Third Molar, run by Baskent 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 2 inclusion and 5 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 24 Nov 2020. 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?
Probing pocket Depth (PPD) (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT04641533, 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 24 Nov 2020.