EdentulismNCT06943846
Platelet-Rich Fibrinogen in Extraction Socket Healing of the Aged
A study testing Platelet-rich fibrin (PRF) in people with Edentulism, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to better understand oral wound healing in the aged participant following placement of platelet-rich fibrinogen (PRF). In this study, 12 participants requiring a posterior tooth extraction will be enroll: 6 participants aged 14-18, 6 participants aged 50-80. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Edentulism
- What is being tested?
- Platelet-rich fibrin (PRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 May 2027
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient at University of Nebraska Medical Center (UNMC) College of Dentistry
- Requires extraction of posterior tooth
- Able and willing to provide consent/assent
Who cannot join
- Systemic conditions that delay wound healing
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate, bisphosphonates or other drugs that inhibit wound healing Smoking and vaping Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center College of Dentistry
Lincoln, Nebraska, 68358
Amy C Killeen, DDS, MS, 402-472-7948, akilleen@unmc.edu
About this study
Official title: Wound Healing Outcomes in Aged Extraction Patient With Platelet Rich Fibrinogen
The purpose of this study is to better understand oral wound healing in the aged participant following placement of platelet-rich fibrinogen (PRF). In this study, 12 participants requiring a posterior tooth extraction will be enroll: 6 participants aged 14-18, 6 participants aged 50-80. All will undergo a posterior tooth extraction with a small tissue specimen taken from the extraction site. Half of the participants will also have their blood drawn and platelet-rich fibrinogen placed in the extraction socket. Participants will return in 2 weeks for suture removal and another soft tissue sample. Participants will return at 3 months for a final post-operative radiograph. All soft tissue samples will undergo immunofluorescence.
Read the detailed description
Twelve participants who are patients at the University of Nebraska Medical Center College of Dentistry who are seeking care to extract a posterior tooth (premolar, molar) due to a periodontal or endodontic defect, non-restorable caries or fracture, serial extractions for orthodontic purposes and who are considering a dental implant to replace the extracted tooth, will be enrolled. On the day of extraction, baseline data will be collected: gender, smoking status and medical history. Hemoglobin A1C (HbA1C) will be tested via a simple finger prick to determine if participant's long-term blood glucose levels could be associated to oral wound healing. A peripheral blood draw will be obtained for platelet-rich fibrinogen (PRF) application.
Prior to extraction, clinical measurements [probing depth (PD), recession, and bleeding on probing (BOP)] will be collected at 6 sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) to assess inflammatory periodontitis severity. A limited-field cone beam commuted tomography (CBCT) radiograph will be taken to assess bone anatomy for future extraction/implant planning and to confirm the probable lack of need for bone augmentation/grafting following extraction. Gingival crevicular fluid (GCF) will be sampled at the interproximal sites of teeth adjacent to the tooth to be extracted. The tooth to be extracted will be isolated with cotton rolls and gingival crevicular fluid (GCF) collection paper strips will be placed into the facial and lingual interproximal gingival sulci for 30 seconds. The paper samples will be pooled and placed in a plastic-capped vial labeled with the participant's number and visit and immediately frozen at -80° C. The presence of explorer-detectable plaque will be ascertained on 6 sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) on tooth to be extracted and adjacent teeth.
Routine atraumatic dental extraction under local anesthesia will be completed by the assigned periodontal resident and faculty. Immediately after the extraction, the resident/fellow will remove a small piece of gingival/mucosal tissue (approximately 3 mm x 3 mm x 3 mm) from the mesial or distal interproximal sites of the extracted tooth and suture the site with chromic gut suture. Soft tissue samples will be immediately placed in formalin. Participants will be scheduled for a routine post-operative visit one, two or three weeks following the extraction. At this visit, suture removal and evaluation of healing site will occur. GCF collection on the remaining adjacent teeth will occur as will collection of granulation tissue (3 mm x 3 mm x 3 mm) from the extraction site. Due to minimal/lack of innervation of granulation tissue, it is not anticipated that anesthesia will be necessary to collect a sample, however, local anesthesia can be administered if the participant reports sensitivity at suture removal. The final post-operative visit will be 3 months following the extraction. A limited-field cone-beam computed tomography (CBCT) will be taken to begin the process of implant treatment planning for bone height, width and volume. All baseline clinical measures (PD/recession/BOP) as well as GCF sampling will be completed on adjacent teeth. The soft tissue samples will be processed for immunofluorescence.
- Conditions
- Edentulism
- Being tested
- Platelet-rich fibrin (PRF)
- Keywords
- extraction, platelet-rich, fibrin, healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Procedure or surgery
Platelet-rich fibrin added to extraction socket
| Study group | Role | What they receive |
|---|---|---|
| Aged Participants Treated with Platelet-rich Fibrinogen | Active comparator | Participants aged 50 to 80 years of age will receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction. Receives: Procedure: Platelet-rich fibrin (PRF) |
| Aged Control | No intervention | Participants aged 50 to 80 years of age will not receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction. |
| Young Participants Treated with Platelet-rich Fibrinogen | Active comparator | Participants aged 14 to 18 years of age will receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction. Receives: Procedure: Platelet-rich fibrin (PRF) |
| Young Control | No intervention | Participants aged 14 to 18 years of age will not receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine Concentration
Indirect immunofluorescent intensity will determine concentration of cytokines present in sample.
Measured: Baseline and two weeks post-extraction
Secondary outcomes (1)
Bone Density
Bone density as measured through cone beam computed tomography (CBCT) and Hounsfeld units will determine density of new bone formation.
Measured: 3 months post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy C Killeen, DDS, MS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943846
- Sponsor's protocol ID
- 0153-25-FB
- Status last verified
- Jan 2026
- First submitted
- 18 Mar 2025
- Last updated
- 8 Oct 2026
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing Outcomes in Aged Extraction Patient With Platelet Rich Fibrinogen
- ClinicalTrials.gov ID
- NCT06943846
- Acronym / sponsor ID
- 0153-25-FB
- Conditions
- Edentulism
- Keywords
- extraction, platelet-rich, fibrin, healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Apr 2025 (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 better understand oral wound healing in the aged participant following placement of platelet-rich fibrinogen (PRF). In this study, 12 participants requiring a posterior tooth extraction will be enroll: 6 participants aged 14-18, 6 participants aged 50-80. All will undergo a posterior tooth extraction with a small tissue specimen taken from the extraction site. Half of the participants will also have their blood drawn and platelet-rich fibrinogen placed in the extraction socket. Participants will return in 2 weeks for suture removal and another soft tissue sample. Participants will return at 3 months for a final post-operative radiograph. All soft tissue samples will undergo immunofluorescence.
Detailed description
Twelve participants who are patients at the University of Nebraska Medical Center College of Dentistry who are seeking care to extract a posterior tooth (premolar, molar) due to a periodontal or endodontic defect, non-restorable caries or fracture, serial extractions for orthodontic purposes and who are considering a dental implant to replace the extracted tooth, will be enrolled. On the day of extraction, baseline data will be collected: gender, smoking status and medical history. Hemoglobin A1C (HbA1C) will be tested via a simple finger prick to determine if participant's long-term blood glucose levels could be associated to oral wound healing. A peripheral blood draw will be obtained for platelet-rich fibrinogen (PRF) application.
Prior to extraction, clinical measurements [probing depth (PD), recession, and bleeding on probing (BOP)] will be collected at 6 sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) to assess inflammatory periodontitis severity. A limited-field cone beam commuted tomography (CBCT) radiograph will be taken to assess bone anatomy for future extraction/implant planning and to confirm the probable lack of need for bone augmentation/grafting following extraction. Gingival crevicular fluid (GCF) will be sampled at the interproximal sites of teeth adjacent to the tooth to be extracted. The tooth to be extracted will be isolated with cotton rolls and gingival crevicular fluid (GCF) collection paper strips will be placed into the facial and lingual interproximal gingival sulci for 30 seconds. The paper samples will be pooled and placed in a plastic-capped vial labeled with the participant's number and visit and immediately frozen at -80° C. The presence of explorer-detectable plaque will be ascertained on 6 sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) on tooth to be extracted and adjacent teeth.
Routine atraumatic dental extraction under local anesthesia will be completed by the assigned periodontal resident and faculty. Immediately after the extraction, the resident/fellow will remove a small piece of gingival/mucosal tissue (approximately 3 mm x 3 mm x 3 mm) from the mesial or distal interproximal sites of the extracted tooth and suture the site with chromic gut suture. Soft tissue samples will be immediately placed in formalin. Participants will be scheduled for a routine post-operative visit one, two or three weeks following the extraction. At this visit, suture removal and evaluation of healing site will occur. GCF collection on the remaining adjacent teeth will occur as will collection of granulation tissue (3 mm x 3 mm x 3 mm) from the extraction site. Due to minimal/lack of innervation of granulation tissue, it is not anticipated that anesthesia will be necessary to collect a sample, however, local anesthesia can be administered if the participant reports sensitivity at suture removal. The final post-operative visit will be 3 months following the extraction. A limited-field cone-beam computed tomography (CBCT) will be taken to begin the process of implant treatment planning for bone height, width and volume. All baseline clinical measures (PD/recession/BOP) as well as GCF sampling will be completed on adjacent teeth. The soft tissue samples will be processed for immunofluorescence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aged Participants Treated with Platelet-rich Fibrinogen | Active comparator | Procedure: Platelet-rich fibrin (PRF)Participants aged 50 to 80 years of age will receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction. |
| Aged Control | No intervention | –Participants aged 50 to 80 years of age will not receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction. |
| Young Participants Treated with Platelet-rich Fibrinogen | Active comparator | Procedure: Platelet-rich fibrin (PRF)Participants aged 14 to 18 years of age will receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction. |
| Young Control | No intervention | –Participants aged 14 to 18 years of age will not receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient at University of Nebraska Medical Center (UNMC) College of Dentistry
- Requires extraction of posterior tooth
- Able and willing to provide consent/assent
Key exclusion criteria (2 listed)
- Systemic conditions that delay wound healing
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate, bisphosphonates or other drugs that inhibit wound healing Smoking and vaping Pregnancy
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 |
|---|---|---|
| Platelet-rich fibrin (PRF)Platelet-rich fibrin added to extraction socket | Procedure or surgery | Aged Participants Treated with Platelet-rich Fibrinogen, Young Participants Treated with Platelet-rich Fibrinogen |
Primary outcome
Cytokine Concentration
Time frame: Baseline and two weeks post-extraction
Indirect immunofluorescent intensity will determine concentration of cytokines present in sample.
1 secondary outcome
Bone Density
Time frame: 3 months post-extraction
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 8 Oct 2026.
- 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.
Amy C Killeen, DDS, MS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich fibrin (PRF) in people with Edentulism, run by University of Nebraska at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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 United States. 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 Amy C Killeen, DDS, MS (402-472-7848, akilleen@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine Concentration (time frame: Baseline and two weeks post-extraction). 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 Oct 2026.