NCT07595198

Brief Summary

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. 1.One socket (test side) will get PRF + bone graft (this combination is also called "sticky bone").
  2. 2.The other socket (control side) will get a bone graft + a covering called a barrier membrane (made of collagen).
  3. 3.How the gums close over the area
  4. 4.How much pain you feel
  5. 5.How much the bone changes
  6. 6.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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 19, 2026

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

Platelet Rich FibrinExtraction, tooth

Outcome Measures

Primary Outcomes (1)

  • Change in alveolar ridge dimensions

    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.

    4 months after ridge preservation (prior to implant placement)

Secondary Outcomes (4)

  • Wound healing (re-epithelialization)

    1, 2, 3, and 4 weeks after ridge preservation

  • Percentage of new bone formation

    4 months after ridge preservation (at implant placement)

  • Crestal soft tissue thickness

    4 months after ridge preservation (at implant placement)

  • Postoperative pain score

    1, 2, 3, and 4 weeks after ridge preservation

Study Arms (2)

PRF-solidified bone graft

EXPERIMENTAL

Extraction socket is grafted with freeze-dried bone allograft (FDBA) mixed with autologous platelet-rich fibrin (PRF) to form a cohesive graft, without placement of a barrier membrane.

Biological: Platelet-rich fibrin (PRF)Device: Freeze-dried bone allograft

Bone Graft With Collagen Membrane

ACTIVE COMPARATOR

Extraction socket is grafted with freeze-dried bone allograft (FDBA) and covered with a resorbable collagen membrane for ridge preservation.

Device: Freeze-dried bone allograftDevice: Collagen barrier membrane

Interventions

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

PRF-solidified bone graft

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

Bone Graft With Collagen MembranePRF-solidified bone graft

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

Bone Graft With Collagen Membrane

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Tooth InjuriesTooth DiseasesStomatognathic DiseasesWounds and Injuries

Central Study Contacts

Siraj Zabadi, DDS

CONTACT

Guo-Liang Cheng, DDS, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized split-mouth clinical trial in which each participant receives both interventions at different intraoral sites, allowing for a within-subject comparison
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 19, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 19, 2026

Record last verified: 2025-08