12 Participants Needed

Platelet-Rich Fibrinogen for Toothlessness

AC
Overseen ByAmy C Killeen, DDS, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

If you are taking medications like NSAIDs, methotrexate, or bisphosphonates, you may need to stop, as these drugs can delay wound healing. The trial does not specify a washout period, but it's important to discuss your current medications with the study team.

What data supports the effectiveness of the treatment Platelet-rich fibrin (PRF) for toothlessness?

Research shows that Platelet-rich fibrin (PRF) can help improve soft tissue healing and bone regeneration after tooth extraction, making it a promising treatment for oral surgery. It has been associated with early bone formation, faster healing, and less pain and swelling after surgery.12345

Is Platelet-Rich Fibrin (PRF) safe for use in humans?

Platelet-Rich Fibrin (PRF) is generally considered safe for use in humans, as it is derived from the patient's own blood and does not require additional chemicals. It has been used in various dental and surgical procedures to promote healing and reduce adverse events.45678

How is the treatment Platelet-rich fibrin (PRF) unique for toothlessness?

Platelet-rich fibrin (PRF) is unique because it uses a natural concentration of platelets and growth factors from the patient's own blood to promote healing and regeneration, without the need for added chemicals or drugs. This makes it a safe and effective option for improving bone and tissue regeneration in dental applications, such as addressing toothlessness.347910

What is the purpose of this trial?

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.

Research Team

AC

Amy C Killeen, DDS, MS

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for individuals who need a posterior tooth extraction. It includes two age groups: young people aged 14-18 and older adults aged 50-80. Participants must be healthy enough to undergo the procedure, but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Patient at University of Nebraska Medical Center (UNMC) College of Dentistry
Able and willing to provide consent/assent
I need a back tooth removed.

Exclusion Criteria

Systemic conditions that delay wound healing
Smoking and vaping
Pregnancy
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants undergo posterior tooth extraction and receive platelet-rich fibrinogen (PRF) treatment or no treatment

1 day
1 visit (in-person)

Post-operative Follow-up

Participants return for suture removal and evaluation of healing site, with additional soft tissue sampling

2 weeks
1 visit (in-person)

Final Follow-up

Participants return for a final post-operative radiograph and assessment of bone density for implant planning

3 months
1 visit (in-person)

Treatment Details

Interventions

  • Platelet-rich fibrin (PRF)
Trial Overview The study is testing the effects of platelet-rich fibrinogen (PRF) on healing after tooth extraction in different age groups. Half of the participants will receive PRF in their extraction socket, while all will have tissue samples taken at various stages for analysis.
Participant Groups
4Treatment groups
Active Control
Group I: Young Participants Treated with Platelet-rich FibrinogenActive Control1 Intervention
Participants aged 14 to 18 years of age will receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction.
Group II: Aged Participants Treated with Platelet-rich FibrinogenActive Control1 Intervention
Participants aged 50 to 80 years of age will receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction.
Group III: Aged ControlActive Control1 Intervention
Participants aged 50 to 80 years of age will not receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction.
Group IV: Young ControlActive Control1 Intervention
Participants aged 14 to 18 years of age will not receive Platelet-rich Fibrinogen (PRF) treatment after tooth extraction.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

References

The 3 R's for Platelet-Rich Fibrin: A "Super" Tri-Dimensional Biomaterial for Contemporary Naturally-Guided Oro-Maxillo-Facial Soft and Hard Tissue Repair, Reconstruction and Regeneration. [2020]
Comparison of the Efficacy of Platelet-Rich Fibrin and Bone Allograft for Alveolar Ridge Preservation after Tooth Extraction: A Clinical Trial. [2022]
Advanced platelet-rich fibrin (A-PRF) has an impact on the initial healing of gingival regeneration after tooth extraction. [2022]
Evaluation of platelet-rich fibrin and tricalcium phosphate bone graft in bone fill of intrabony defects using cone-beam computed tomography: A randomized clinical trial. [2022]
Comparative evaluation of bone regeneration with platelet-rich fibrin in mandibular third molar extraction socket: A randomized split-mouth study. [2022]
Advanced platelet-rich fibrin and freeze-dried bone allograft for ridge preservation: A randomized controlled clinical trial. [2020]
PRF in dentistry – a short synopsis about implementation and workflow [2019]
Platelet-rich fibrin for wound healing of palatal donor sites of free gingival grafts: Systematic review and meta-analysis. [2022]
Effects of platelet rich fibrin alone used with rigid titanium barrier. [2022]
Role of plasma-rich fibrin in oral surgery. [2020]
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