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

NCT ID: NCT07023757

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-12

Study Completion Date

2026-07-01

Brief Summary

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

Detailed Description

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Platelet-rich fibrin (PRF) is commonly used to enhance gum tissue healing and reducing pain after tooth extraction and before placing a dental implant. 44 patients requiring a tooth extraction will be recruited and randomized to receive a collagen plug with or without platelet-rich fibrin.

Conditions

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Healing Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Platelet-rich fibrin group.

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

Group Type ACTIVE_COMPARATOR

Socket preservation

Intervention Type 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

Collagen plug only

Group Type SHAM_COMPARATOR

Socket preservation

Intervention Type 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.

Interventions

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Socket preservation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Saleh

Clinical Assistant Professor, Periodontics and Oral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Saleh, BDS, MSD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00264197

Identifier Type: -

Identifier Source: org_study_id

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