PRFPRFNCT06406530
Topical Application of PRF Before Radiation Therapy
A study testing PRF and Natural Healing in people with PRF, run by University of Giessen at 1 site in Germany.
Trial summary
The primary goal of this study is to observe whether PRP promotes the wound healing before a radiation therapy or not, compared to the natural healing of a tooth extraction socket. Secondary aim is to monitore the effect on the pain perception. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- PRF
- What is being tested?
- PRF and Natural Healing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and neck cancer with planed radiation therapy
- Bilateral tooth extraction
- Similar tooth size
- Atraumatic tooth extractions without flap surgery
- Patients age above 18y of age
Who cannot join
- Prior radiation therapy in the head and neck area
- Prior and current therapy with bisphosphonates or equivalent modern biologics
- Patients during pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University of Giessen
Giessen, Hesse
Sameh Attia, MSc, +49 176 80732647, Sameh.Attia@dentist.med.uni-gie
About this study
Official title: Topical Application of PRF in Tooth Extraction Sockets Before Radiation Therapy for Head and Neck Cancer
The primary goal of this study is to observe whether PRP promotes the wound healing before a radiation therapy or not, compared to the natural healing of a tooth extraction socket.
Secondary aim is to monitore the effect on the pain perception.
Read the detailed description
Head and neck cancer patients are required for a dental checkup before the beginning of the radiation therapy. During this checkup the patients gets a radiological and clinical examination in order to determine any tooth or alveolar bone bound inflammatory processes. Teeth associated to those conditions, or those which are likely to result in any of this, have to be extracted in order to prevent radiation associated complications such as osteomyelitis or further osteoradionecrosis of the jaw. In order to prevent this illness it is essential to not start before the healing of the post-extraction socket has reached a sufficient state, which is usually around 3 weeks post-extracitonem. To facilitate the healing, recent studies have shown an positive effect by applying PRF and a lower pain perception after surgical tooth removal. So far it is not documented for the prevention of a osteoradionecrosis of the jaw.
The patients who receive two or more tooth extractions before radiation therapy can participate in the study. The preliminary diagnosis has to be a head and neck tumor which is planned to be treated with ionizing radiation equally on both sides of the jaw(s). Both teeth have to have a similar size (e.g. molar and molar).
Patient and Doctors a blinded, the site of PRF Application is chosen by random. After surgical removal of the teeth one extraction socket is filled with PRF while the other is left for its natural formation of a blood clot.
During the first 7 days the patient protocols the pain perception and the amount of painkillers used for both sides of the jaw. After 7d, 14d, 21d, 30d, the wound healing is recorded until it reached is end in complete epithelization.
3 Months after the surgery a intermediate clinical examination is performed for early signs of any complication due to the radiation therapy. 6 Months after the surgery a OPG-radiograph will be taken to determine the bone healing comparing the test site and the control site.
- Conditions
- PRF
- Being tested
- PRF, Natural Healing
- Keywords
- PRF, wound healing, dentistry, oral surgery, radiation therapy, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFProcedure or surgery
Also called Platelet rich fibrin
Patients blood is standardized centrifuged and split in to a red-phase (erythrocytes) and white-phase (PRF). The gained PRF is processed to a clot-fort and is inserted into the alveolus.
Natural HealingProcedure or surgery
Also called Blood clot formation
After the tooth extraction, natural healing is aimed by allowing a blood clot formation without any further intervention.
| Study group | Role | What they receive |
|---|---|---|
| PRF site (test site) | Experimental | The participants become at least two teeth removed, one site is applied with PRF (test site) while the other is left for natural healing by forming a blood clot (control site). Operator and Investigator as well as the Patient are blinded to to the site of application. Receives: Procedure: PRF |
| Blood clot (control site) | Active comparator | The participants become at least two teeth removed, one site is applied with PRF (test site) while the other is left for natural healing by forming a blood clot (control site). Operator and Investigator as well as the Patient are blinded to to the site of application. Receives: Procedure: Natural Healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing between the two sites using the Wound Healing Index
To compare the wound heeling, a modified Landry and Turnbull Healing Index is used. This index varies from 0 to 5, where 0 means no healing and 5 excellent healing.
Measured: around 4 Weeks
Secondary outcomes (1)
PRF and Pain perception
To compare pain perception between the two sites - the PRF test site and the control site - a visual analogue scale (VAS) for pain is provided to the patients. This scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the highest imaginable pain for the patient.
Measured: around 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Dec 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRFStudies 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
- Single group
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Attia, University of Giessen
- Investigators
- Sameh Attia, DDS, MSc, Study director, UKGM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406530
- Sponsor's protocol ID
- TAPRFPR
- Acronym
- PRF
- Status last verified
- Apr 2025
- First submitted
- 6 May 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of PRF in Tooth Extraction Sockets Before Radiation Therapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06406530
- Acronym / sponsor ID
- PRF / TAPRFPR
- Conditions
- PRF
- Keywords
- PRF, wound healing, dentistry, oral surgery, radiation therapy, cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 9 May 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 primary goal of this study is to observe whether PRP promotes the wound healing before a radiation therapy or not, compared to the natural healing of a tooth extraction socket.
Secondary aim is to monitore the effect on the pain perception.
Detailed description
Head and neck cancer patients are required for a dental checkup before the beginning of the radiation therapy. During this checkup the patients gets a radiological and clinical examination in order to determine any tooth or alveolar bone bound inflammatory processes. Teeth associated to those conditions, or those which are likely to result in any of this, have to be extracted in order to prevent radiation associated complications such as osteomyelitis or further osteoradionecrosis of the jaw. In order to prevent this illness it is essential to not start before the healing of the post-extraction socket has reached a sufficient state, which is usually around 3 weeks post-extracitonem. To facilitate the healing, recent studies have shown an positive effect by applying PRF and a lower pain perception after surgical tooth removal. So far it is not documented for the prevention of a osteoradionecrosis of the jaw.
The patients who receive two or more tooth extractions before radiation therapy can participate in the study. The preliminary diagnosis has to be a head and neck tumor which is planned to be treated with ionizing radiation equally on both sides of the jaw(s). Both teeth have to have a similar size (e.g. molar and molar).
Patient and Doctors a blinded, the site of PRF Application is chosen by random. After surgical removal of the teeth one extraction socket is filled with PRF while the other is left for its natural formation of a blood clot.
During the first 7 days the patient protocols the pain perception and the amount of painkillers used for both sides of the jaw. After 7d, 14d, 21d, 30d, the wound healing is recorded until it reached is end in complete epithelization.
3 Months after the surgery a intermediate clinical examination is performed for early signs of any complication due to the radiation therapy. 6 Months after the surgery a OPG-radiograph will be taken to determine the bone healing comparing the test site and the control site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| PRF site (test site) | Experimental | Procedure: PRFThe participants become at least two teeth removed, one site is applied with PRF (test site) while the other is left for natural healing by forming a blood clot (control site). Operator and Investigator as well as the Patient are blinded to to the site of application. |
| Blood clot (control site) | Active comparator | Procedure: Natural HealingThe participants become at least two teeth removed, one site is applied with PRF (test site) while the other is left for natural healing by forming a blood clot (control site). Operator and Investigator as well as the Patient are blinded to to the site of application. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Head and neck cancer with planed radiation therapy
- Bilateral tooth extraction
- Similar tooth size
- Atraumatic tooth extractions without flap surgery
- Patients age above 18y of age
Key exclusion criteria (3 listed)
- Prior radiation therapy in the head and neck area
- Prior and current therapy with bisphosphonates or equivalent modern biologics
- Patients during pregnancy or 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 |
|---|---|---|
| PRFAlso: Platelet rich fibrinPatients blood is standardized centrifuged and split in to a red-phase (erythrocytes) and white-phase (PRF). The gained PRF is processed to a clot-fort and is inserted into the alveolus. | Procedure or surgery | PRF site (test site) |
| Natural HealingAlso: Blood clot formationAfter the tooth extraction, natural healing is aimed by allowing a blood clot formation without any further intervention. | Procedure or surgery | Blood clot (control site) |
Primary outcome
Wound healing between the two sites using the Wound Healing Index
Time frame: around 4 Weeks
To compare the wound heeling, a modified Landry and Turnbull Healing Index is used. This index varies from 0 to 5, where 0 means no healing and 5 excellent healing.
1 secondary outcome
PRF and Pain perception
Time frame: around 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for PRF
Not yet recruiting
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Osteonecrosis of the Jaw
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Not yet recruiting
Platelet-Rich Fibrin for Preventing Osteoradionecrosis After Dental Extractions
Osteoradionecrosis of the Jaw
Recruiting
Different Approaches for Alveolar Ridge Preservation
Alveolar Ridge Resorption
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.
Sameh Attia, DDS, MSc study director
UKGM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF and Natural Healing in people with PRF, run by University of Giessen at 1 site in Germany.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sameh Attia, DDS, MSc ((+49) 641 9946112, Sameh.Attia@dentist.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing between the two sites using the Wound Healing Index (time frame: around 4 Weeks). 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 11 Apr 2025.