Effect of Age on PRF Quality; Assessed by Evaluating Healing Outcomes of ARP

NCT07023757 | Enrolling By Invitation

• 1 other identifier: HUM00264197
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether using PRF and your age are going to affect the healing and regeneration benefits gained from PRF.

Conditions

Healing Wound

Outcome Measures

Primary Outcomes (2)

• Alveolar ridge dimension changes

  Digitally measured alveolar ridge dimension changes in mm\^2 using cone-beam computed tomography

  4 months

• Soft tissue dimension changes

  Digitally measured soft tissue changes in mm\^2 using intraoral scans

  4 months

Secondary Outcomes (4)

• Histological bone density.

  4 months

• Presence of bone turnover proteins.

  4 months

• Amount of growth factors

  At baseline surgery

• Wound healing index

  1 week, 2 weeks, 4 weeks, and 8 weeks

Study Arms (2)

Platelet-rich fibrin group.

ACTIVE COMPARATOR

Following extraction, a Platelet-rich fibrin plug will be placed in the extraction socket and covered with a collagen plug.

Procedure: Socket preservation

Collagen plug only

SHAM COMPARATOR

Collagen plug only

Procedure: Socket preservation

Interventions

Socket preservation PROCEDURE

After tooth extraction, the extraction socket will be filled with a collagen plug in one group or a platelet-rich fibrin plug in the other.

Collagen plug only; Platelet-rich fibrin group.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: 20 to 80 years.
• Patients must require tooth extraction (molars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
• Non-infected sockets with intact buccal bone (≥1.5 mm in thickness measured through calipers)
• Patients interested in implant placement following tooth extraction.

You may not qualify if:

• Allergies or hypersensitivities to study related medications.
• Hematologic disorders/blood dyscrasias.
• Active infectious diseases of any kind.
• Liver or kidney dysfunction/failure.
• Uncontrolled diabetes (HbA1c \> 8).
• Active cancer treatment - such as active chemotherapy or radiation therapy.
• Taking medications that will affect their bone healing (for example, bisphosphonates, Long-term NSAIDs use, Steroid).
• Metabolic bone diseases that affect bone healing such as osteoporosis.
• Pregnant or lactating women (self-reported).
• Smoke 10 or more cigarettes per day (self-reported).
• Poor oral hygiene.
• Systemic diseases that compromise the immune system
• Anti-coagulant therapy

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Muhammad Saleh, BDS, MSD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Periodontics and Oral Medicine

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 17, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)