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Enrolling by invitation NCT07023757

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

No phase Interventional Healing Wound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Socket preservation.
Who it may be relevant to
Registry conditions: Healing Wound. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed 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.

Interventions

  • Procedure 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.

Primary outcome measures

  • Alveolar ridge dimension changes [Time frame: 4 months]
  • Soft tissue dimension changes [Time frame: 4 months]
Secondary outcome measures (4)
  • Histological bone density. [Time frame: 4 months]
  • Presence of bone turnover proteins. [Time frame: 4 months]
  • Amount of growth factors [Time frame: At baseline surgery]
  • Wound healing index [Time frame: 1 week, 2 weeks, 4 weeks, and 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan School of Dentistry — Ann Arbor

Identifiers

NCT: NCT07023757 · HUM00264197

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗