Platelet-Rich FibrinPhase 3NCT05772975
The Clinical Impact of E-PRF and H-PRF on Healing After Mandibular Third Molar Surgery
A Phase 3 study testing H-PRF (Horizontal-platelet rich fibrin) and E-PRF in people with Platelet-Rich Fibrin, run by Amila Haskic at 1 site in Bosnia and Herzegovina.
Trial summary
This clinical trial aims to compare the effect of platelet concentrates E-PRF and H-PRF on soft and hard tissue healing in healthy individuals after lower third molar surgery. The main questions it aims to answer are: Do E-PRF and H-PRF reduce complications after third molar surgery? Do E-PRF and H-PRF improve soft… Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet-Rich Fibrin
- What is being tested?
- H-PRF (Horizontal-platelet rich fibrin) and E-PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 21 May 2021to 30 Jan 2024
- Phase
- Phase 3
- 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 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Orthodontic indication for impacted mandibular third molar surgery
- Physical status I according to the guidelines of the American Society of Anesthesiologists (ASA)
Who cannot join
- Presence of systemic disease
- Presence of a condition that affects fibrin clot formation
- History of radiation therapy or chemotherapy
- Allergy to penicillin
- Oral contraceptive usage
- Smoking habit
Show all 9Show fewer
- Status of pregnancy or lactation
- Presence of any acute local infection
- Missing the adjacent second molar or indicated for extraction
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
Faculty of Dentistry with Dental Clinical Center
Sarajevo, Federation of Bosnia and Herzegovina, 71000
About this study
Official title: Evaluation of Soft and Hard Tissue Healing After Impacted Mandibular Third Molar Surgery With the Use of E-PRF and H-PRF - a Randomized Controlled Clinical Study
This clinical trial aims to compare the effect of platelet concentrates E-PRF and H-PRF on soft and hard tissue healing in healthy individuals after lower third molar surgery. The main questions it aims to answer are:
Do E-PRF and H-PRF reduce complications after third molar surgery? Do E-PRF and H-PRF improve soft tissue healing after third molar surgery? Do E-PRF and H-PRF improve hard tissue healing after third molar surgery? Participants will be divided into 2 study groups and one control group. Third molar surgery will be performed according to standard protocol. In study groups, dentoalveolar defects will be filled with E-PRF and H-PRF which are products of centrifugation of the patient's blood without additives. Soft tissue and hard tissue healing will be compared between the groups.
Read the detailed description
A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of E-PRF vs H-PRF vs Control on the soft tissue healing and post-op discomfort and complications after mandibular third molar surgery between the three groups during the healing period of 7 days.
The secondary objective is to compare bony healing between the three groups over three months using an Orthopantomograph (OPG) X-ray.
All subjects from the University of Sarajevo Faculty of Dentistry with Dental Clinical Center. Subjects that are coming for the removal of impacted mandibular third molars and match the inclusion criteria will be told about the research and offered the opportunity to participate.
- Conditions
- Platelet-Rich Fibrin
- Being tested
- H-PRF (Horizontal-platelet rich fibrin), E-PRF
- Keywords
- Molar, Third, PRF, Platelet-Rich Fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-PRF (Horizontal-platelet rich fibrin)Biological
Platelet-rich fibrin is an autologous biomaterial originating from human blood following centrifugation without additives that contains supraphysiological doses of growth factors. it serves as a biological healing matrix by supporting cell migration and cytokine release. H-PRF is obtained by horizontal centrifugation using (Bio-PRF) centrifuge on 700 g force for 8 minutes. This way the cells separate much more efficiently throughout the entire membrane/clot.
E-PRFBiological
Platelet-rich fibrin is an autologous biomaterial originating from human blood following centrifugation without additives that contains supraphysiological doses of growth factors. In order to extend its resorption period heating method is used. After centrifugation of blood using (Bio-PRF) centrifuge on 700 g force for 8 minutes top layer is heated for 10 minutes at 75°C in BIO-Heat device. When cooled it is mixed with cell rich buffy coat. This way PRF with extended life is obtained.
| Study group | Role | What they receive |
|---|---|---|
| E-PRF | Experimental | After the impacted mandibular third molar has been surgically removed E-PRF is placed in the dentoalveolar defect and the wound is primarily closed. Receives: Biological: E-PRF |
| H-PRF | Experimental | After the impacted mandibular third molar has been surgically removed H-PRF is placed in the dentoalveolar defect PRF made with horizontal centrifuge and the wound is primarily closed. Receives: Biological: H-PRF (Horizontal-platelet rich fibrin) |
| CONTROL | No intervention | After the impacted mandibular third molar has been surgically removed, the wound is primarily closed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of E-PRF vs H-PRF vs Control on soft tissue healing
Soft tissue healing evaluation will be done by modified Landry, Turnbull and Howley healing index. For each post-extraction site, the following parameters will be evaluated by dichotomic scale (0/1): tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins and suppuration.
Measured: 3 days
The impact of E-PRF vs H-PRF vs Control on soft tissue healing
Soft tissue healing evaluation will be done by modified Landry, Turnbull and Howley healing index. For each post-extraction site, the following parameters will be evaluated by dichotomic scale (0/1): tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins and suppuration.
Measured: 7 days
The impact of E-PRF vs H-PRF vs Control on bone regeneration
Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.
Measured: 1 month
The impact of E-PRF vs H-PRF vs Control on bone regeneration
Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.
Measured: 3 months
Secondary outcomes (7)
The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth
Pocket depth will be measured using a periodontal probe taken from the margin of the gingiva to the base of the pocket along the distal surface of the mandibular second molar at three points: distobuccal, mid-distal, distolingual- by a single evaluator. Periodontal pocket depth will be measured preoperatively, one month and three months postoperatively
Measured: 1 month
The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth
Pocket depth will be measured using a periodontal probe taken from the margin of the gingiva to the base of the pocket along the distal surface of the mandibular second molar at three points: distobuccal, mid-distal, distolingual.
Measured: 3 months
The impact of E-PRF vs H-PRF vs Control on postoperative trismus
The primary outcome is to asses the percentage of trismus after mandibular third molar surgery in study groups vs control. Trismus will be measured as the distance between the upper right and lower right central incisors during maximum mouth opening using digital caliper.
Measured: 3 days
The impact of E-PRF vs H-PRF vs Control on postoperative trismus
The primary outcome is to asses the percentage of trismus after mandibular third molar surgery in study groups vs control. Trismus will be measured as the distance between the upper right and lower right central incisors during maximum mouth opening using digital caliper.
Measured: 7 days
The impact of E-PRF vs H-PRF vs Control on postoperative swelling
The primary outcome is to asses the percentage of swelling after mandibular third molar surgery in study groups vs control. Facial swelling will be evaluated by measuring 3 facial distances: from the tragus to pogonion (TPO), tragus to labial commissure (TCO), and angulus mandibulae to lateral canthus (ACA).
Measured: 3 days
The impact of E-PRF vs H-PRF vs Control on postoperative swelling
The primary outcome is to asses the percentage of swelling after mandibular third molar surgery in study groups vs control. Facial swelling will be evaluated by measuring 3 facial distances: from the tragus to pogonion (TPO), tragus to labial commissure (TCO), and angulus mandibulae to lateral canthus (ACA).
Measured: 7 days
The impact of E-PRF vs H-PRF vs Control on postoperative pain
The primary outcome is to asses the level of pain after mandibular third molar surgery in study groups vs control. A visual analog scale (VAS) will be used to evaluate postoperative pain. A 10-point VAS with a score of 0 equals "no pain" and 10 equals "very severe pain" will be used to asses subjective pain. Patients will be asked to record number of analgesic taken during the monitoring period of 7days.
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 posted17 Mar 2023
- Study start21 May 2021
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-Rich FibrinStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amila Haskic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amila Haskic, University of Sarajevo
- Investigators
- Amila Haskic, Principal investigator, University of Sarajevo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772975
- Sponsor's protocol ID
- 02-3-4-59-1-3/2021
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2023
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft and Hard Tissue Healing After Impacted Mandibular Third Molar Surgery With the Use of E-PRF and H-PRF - a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05772975
- Acronym / sponsor ID
- 02-3-4-59-1-3/2021
- Conditions
- Platelet-Rich Fibrin
- Keywords
- Molar, Third, PRF, Platelet-Rich Fibrin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Amila HaskicUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 17 Mar 2023 (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 clinical trial aims to compare the effect of platelet concentrates E-PRF and H-PRF on soft and hard tissue healing in healthy individuals after lower third molar surgery. The main questions it aims to answer are:
Do E-PRF and H-PRF reduce complications after third molar surgery? Do E-PRF and H-PRF improve soft tissue healing after third molar surgery? Do E-PRF and H-PRF improve hard tissue healing after third molar surgery? Participants will be divided into 2 study groups and one control group. Third molar surgery will be performed according to standard protocol. In study groups, dentoalveolar defects will be filled with E-PRF and H-PRF which are products of centrifugation of the patient's blood without additives. Soft tissue and hard tissue healing will be compared between the groups.
Detailed description
A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of E-PRF vs H-PRF vs Control on the soft tissue healing and post-op discomfort and complications after mandibular third molar surgery between the three groups during the healing period of 7 days.
The secondary objective is to compare bony healing between the three groups over three months using an Orthopantomograph (OPG) X-ray.
All subjects from the University of Sarajevo Faculty of Dentistry with Dental Clinical Center. Subjects that are coming for the removal of impacted mandibular third molars and match the inclusion criteria will be told about the research and offered the opportunity to participate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E-PRF | Experimental | Biological: E-PRFAfter the impacted mandibular third molar has been surgically removed E-PRF is placed in the dentoalveolar defect and the wound is primarily closed. |
| H-PRF | Experimental | Biological: H-PRF (Horizontal-platelet rich fibrin)After the impacted mandibular third molar has been surgically removed H-PRF is placed in the dentoalveolar defect PRF made with horizontal centrifuge and the wound is primarily closed. |
| CONTROL | No intervention | –After the impacted mandibular third molar has been surgically removed, the wound is primarily closed. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Orthodontic indication for impacted mandibular third molar surgery
- Physical status I according to the guidelines of the American Society of Anesthesiologists (ASA)
Key exclusion criteria (9 listed)
- Presence of systemic disease
- Presence of a condition that affects fibrin clot formation
- History of radiation therapy or chemotherapy
- Allergy to penicillin
- Oral contraceptive usage
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 |
|---|---|---|
| H-PRF (Horizontal-platelet rich fibrin)Platelet-rich fibrin is an autologous biomaterial originating from human blood following centrifugation without additives that contains supraphysiological doses of growth factors. it serves as a biological healing matrix by supporting cell migration and cytokine release. H-PRF is obtained by horizontal centrifugation using (Bio-PRF) centrifuge on 700 g force for 8 minutes. This way the cells separate much more efficiently throughout the entire membrane/clot. | Biological | H-PRF |
| E-PRFPlatelet-rich fibrin is an autologous biomaterial originating from human blood following centrifugation without additives that contains supraphysiological doses of growth factors. In order to extend its resorption period heating method is used. After centrifugation of blood using (Bio-PRF) centrifuge on 700 g force for 8 minutes top layer is heated for 10 minutes at 75°C in BIO-Heat device. When cooled it is mixed with cell rich buffy coat. This way PRF with extended life is obtained. | Biological | E-PRF |
Primary outcome
The impact of E-PRF vs H-PRF vs Control on soft tissue healing
Time frame: 3 days
Soft tissue healing evaluation will be done by modified Landry, Turnbull and Howley healing index. For each post-extraction site, the following parameters will be evaluated by dichotomic scale (0/1): tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins and suppuration.
The impact of E-PRF vs H-PRF vs Control on soft tissue healing
Time frame: 7 days
Soft tissue healing evaluation will be done by modified Landry, Turnbull and Howley healing index. For each post-extraction site, the following parameters will be evaluated by dichotomic scale (0/1): tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins and suppuration.
The impact of E-PRF vs H-PRF vs Control on bone regeneration
Time frame: 1 month
Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.
The impact of E-PRF vs H-PRF vs Control on bone regeneration
Time frame: 3 months
Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.
7 secondary outcomes
The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth
Time frame: 1 month
The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth
Time frame: 3 months
The impact of E-PRF vs H-PRF vs Control on postoperative trismus
Time frame: 3 days
The impact of E-PRF vs H-PRF vs Control on postoperative trismus
Time frame: 7 days
The impact of E-PRF vs H-PRF vs Control on postoperative swelling
Time frame: 3 days
The impact of E-PRF vs H-PRF vs Control on postoperative swelling
Time frame: 7 days
The impact of E-PRF vs H-PRF vs Control on postoperative pain
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 9 Aug 2024.
- 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.
Amila Haskic principal investigator
University of Sarajevo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing H-PRF (Horizontal-platelet rich fibrin) and E-PRF in people with Platelet-Rich Fibrin, run by Amila Haskic at 1 site in Bosnia and Herzegovina.
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 9 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 9 Aug 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 Bosnia and Herzegovina. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The impact of E-PRF vs H-PRF vs Control on soft tissue healing (time frame: 3 days). The study lists 4 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 9 Aug 2024.