Platelet-Rich Fibrinogen in Extraction Socket Healing of the Aged

NCT06943846 | Recruiting

• 1 other identifier: 0153-25-FB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Edentulism

Keywords

extraction; platelet-rich; fibrin; healing

Outcome Measures

Primary Outcomes (1)

• Cytokine Concentration

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

  Baseline and two weeks post-extraction

Secondary Outcomes (1)

• Bone Density

  3 months post-extraction

Study Arms (4)

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.

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.

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.

Interventions

Platelet-rich fibrin (PRF) PROCEDURE

Platelet-rich fibrin added to extraction socket

Aged Participants Treated with Platelet-rich Fibrinogen; Young Participants Treated with Platelet-rich Fibrinogen

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at University of Nebraska Medical Center (UNMC) College of Dentistry
• Requires extraction of posterior tooth
• Able and willing to provide consent/assent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center College of Dentistry

Lincoln, Nebraska, 68358, United States

RECRUITING

Study Officials

• Amy C Killeen, DDS, MS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy C Killeen, DDS, MS

CONTACT

402-472-7848; akilleen@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)