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

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University of Michigan

Status

Invitation-only

Conditions

Healing Wound

Treatments

Procedure: Socket preservation

Study type

Interventional

Funder types

Other

Identifiers

NCT07023757
HUM00264197

Details and patient eligibility

About

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

Full description

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.

Enrollment

44 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Platelet-rich fibrin group.
Active Comparator group
Description:
Following extraction, a Platelet-rich fibrin plug will be placed in the extraction socket and covered with a collagen plug.
Treatment:
Procedure: Socket preservation
Collagen plug only
Sham Comparator group
Description:
Collagen plug only
Treatment:
Procedure: Socket preservation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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