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NCT Number: NCT07595198

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

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).

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Key information

Conditions

Extraction, Tooth Fractures, Bone Root; Fracture Stomatognathic Diseases Tooth Crown Fracture Tooth Diseases Tooth Fracture Tooth Fractures Tooth Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-rich fibrin (PRF)

Biological

Autologous platelet concentrate prepared from the participant's blood and applied to the extraction socket, mixed with bone graft.

Freeze-dried bone allograft

Device

Human-derived bone graft material used to fill extraction sockets for ridge preservation

Collagen barrier membrane

Device

Resorbable membrane placed over the grafted socket to stabilize the graft and prevent soft tissue ingrowth.

Primary outcomes

  1. Change in alveolar ridge dimensions

    Time frame: 4 months after ridge preservation (prior to implant placement)

    Change in alveolar ridge width and height will be measured by superimposing baseline and 4-month follow-up cone-beam computed tomography (CBCT) images at standardized cross-sectional locations corresponding to the extraction sites.

Secondary outcomes

  1. Wound healing (re-epithelialization)

    Time frame: 1, 2, 3, and 4 weeks after ridge preservation

    Soft tissue wound closure over extraction sites will be assessed using serial intraoral scans and analyzed to quantify changes in wound area over time.

  2. Percentage of new bone formation

    Time frame: 4 months after ridge preservation (at implant placement)

    Bone core biopsies obtained at implant placement will be analyzed histologically to determine the percentage of newly formed bone within the grafted sites.

  3. Crestal soft tissue thickness

    Time frame: 4 months after ridge preservation (at implant placement)

    Soft tissue thickness at the alveolar crest will be measured clinically using a periodontal probe at the time of implant placement.

  4. Postoperative pain score

    Time frame: 1, 2, 3, and 4 weeks after ridge preservation

    Participant-reported pain will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Guo-Liang Cheng, DDS, MS

CONTACT

[email protected]

Siraj Zabadi, DDS

CONTACT

[email protected]

614-206-0298

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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