Menu
Not yet recruiting NCT07595198

Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction

No phase Interventional Extraction, Tooth Tooth Fracture Tooth Crown Fracture Root; Fracture

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: Platelet-rich fibrin (PRF), Freeze-dried bone allograft, Collagen barrier membrane.
Who it may be relevant to
Registry conditions: Extraction, Tooth, Tooth Fracture, Tooth Crown Fracture, Root; Fracture. Basic parameters: 18 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Application of Platelet-Rich Fibrin Consolidated Bone Substitutes in Alveolar Ridge Preservation: A Randomized Controlled Study

Overview

This study uses a natural material called Platelet-Rich Fibrin (PRF) to help improve healing after tooth removal. PRF is made from your own blood. A small amount of blood is taken from your arm and spun in a machine to make a thick, sticky layer full of platelets. These platelets help your body heal. PRF acts like a "natural bandage" and may help your gums and bone heal faster. Because it comes from your own body, it is safe and lowers the chance of infection or problems. The goal of this research is to see if adding PRF to a bone graft (used to fill the tooth socket after extraction) can help the area heal faster and grow more new bone. If you join this study, it will last about 4 months. You will have two teeth removed, and each socket will get a different treatment: 1. One socket (test side) will get PRF + bone graft (this combination is also called "sticky bone"). 2. The other socket (control side) will get a bone graft + a covering called a barrier membrane (made of collagen). We will compare how well the two sides heal by looking at: 1. How the gums close over the area 2. How much pain you feel 3. How much the bone changes 4. How much new bone grows You will come to the clinic for about 9 visits in total. These visits are part of your regular treatment, along with a few extra steps for the study. One possible risk is bruising or soreness from the blood draw. If we cannot collect enough blood (about 60-80 ml) because your veins are too small or hard to find, you will not continue in the study, and both sockets will be treated using the control method (bone graft + membrane).

Interventions

  • Biological Platelet-rich fibrin (PRF)
    Autologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft.
  • Device Freeze-dried bone allograft
    Human-derived bone graft material used to fill extraction sockets for ridge preservation
  • Device Collagen barrier membrane
    Resorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.

Primary outcome measures

  • Change in alveolar ridge dimensions [Time frame: 4 months after ridge preservation (prior to implant placement)]
Secondary outcome measures (4)
  • Wound healing (re-epithelialization) [Time frame: 1, 2, 3, and 4 weeks after ridge preservation]
  • Percentage of new bone formation [Time frame: 4 months after ridge preservation (at implant placement)]
  • Crestal soft tissue thickness [Time frame: 4 months after ridge preservation (at implant placement)]
  • Postoperative pain score [Time frame: 1, 2, 3, and 4 weeks after ridge preservation]

Eligibility criteria

Inclusion criteria

  • Patients of age between 18-80.
  • Non-smokers or former smokers with at least a 5-year successful cessation history.
  • Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction and cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
  • Patients treatment planned for extraction and ridge preservation for at least 2 non-adjacent single-rooted teeth.

Exclusion criteria

  • Current smokers, smokers who have quit <5 years prior to study entry.
  • Pregnant or lactating women
  • Patients with substance or alcohol abuse
  • Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
  • Other systemic conditions or medications affecting wound healing.
  • Poor plaque control with plaque score > 20%
  • Active/untreated odontogenic and periodontal infections

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07595198 · STUDY20250322

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗