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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Amy C Killeen, DDS, MS contact

402-472-7848

akilleen@unmc.edu

United States1 site, 1 recruiting
  • University of Nebraska Medical Center College of Dentistry

    Lincoln, Nebraska, 68358

    Amy C Killeen, DDS, MS, 402-472-7948, akilleen@unmc.edu

    Recruiting

Other trials in United States

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 groups in NCT06943846
Study groupRoleWhat they receive
Aged Participants Treated with Platelet-rich FibrinogenActive comparatorParticipants aged 50 to 80 years of age will receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction.
Receives: Procedure: Platelet-rich fibrin (PRF)
Aged ControlNo interventionParticipants aged 50 to 80 years of age will not receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction.
Young Participants Treated with Platelet-rich FibrinogenActive comparatorParticipants aged 14 to 18 years of age will receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction.
Receives: Procedure: Platelet-rich fibrin (PRF)
Young ControlNo interventionParticipants 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.

  1. Cytokine Concentration

    Indirect immunofluorescent intensity will determine concentration of cytokines present in sample.

    Measured: Baseline and two weeks post-extraction

Secondary outcomes (1)
  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.

  1. First posted24 Apr 2025
  2. Study start1 May 2025
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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)
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

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.

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