Study on Platelet-Rich Fibrin for Preserving Jawbone After Tooth Extraction Using CBCT Imaging in Adults

NCT07022860 | Completed

• 1 other identifier: IR.ZAUMS.REC.1403.379
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if platelet-rich fibrin (PRF), a substance made from a person's own blood, helps preserve the bone in the jaw after tooth extraction in adults. The main questions it aims to answer are: Does PRF help reduce the loss of bone height after tooth removal? Does PRF improve how much of the socket fills with new bone? Researchers will compare extraction sites treated with PRF to untreated sites in the same person to see if PRF helps preserve more bone. Participants will: Have two teeth removed on opposite sides of the mouth Receive PRF in one socket, while the other socket is left to heal naturally Undergo 3D X-ray scans (CBCT) right after extraction and again 3 months later This study will help researchers understand if using PRF alone can improve healing and reduce bone loss after tooth extraction.

Conditions

Socket Preservation

Outcome Measures

Primary Outcomes (1)

• Change in Vertical Ridge Height from Baseline to 3 Months Post-Extraction as Measured by Cone-Beam Computed Tomography (CBCT)

  Vertical ridge height was measured using cone-beam computed tomography (CBCT) at two time points: immediately after tooth extraction (baseline) and at 3 months post-extraction. Measurements were taken from the crest of the alveolar ridge to the apex of the extraction socket on both the buccal and lingual sides. The difference in ridge height between the two time points represents the amount of vertical bone loss. A smaller change indicates better preservation of ridge height. The measurements were performed by a blinded radiologist using standardized 1 mm slice thickness and reference lines drawn from the socket apex to the ridge crest.

  Immediately post-extraction (baseline) and at 3 months post-extraction

Secondary Outcomes (2)

• Change in Horizontal Ridge Width at 1 mm, 3 mm, and 5 mm Apical to the Crest from Baseline to 3 Months Post-Extraction Measured by CBCT

  Immediately post-extraction (baseline) and at 3 months post-extraction

• Percentage of Socket Fill at 3 Months Post-Extraction as Measured by CBCT

  3 months post-extraction

Study Arms (2)

Split-Mouth PRF Arm

EXPERIMENTAL

Each participant will have two symmetrical tooth extractions. One socket will be randomly assigned to receive platelet-rich fibrin (PRF), and the contralateral socket will serve as a control, healing naturally without any graft material. This split-mouth design allows each participant to act as their own control. Radiographic assessments using cone-beam computed tomography (CBCT) will be conducted at baseline and 3 months to measure bone height, ridge width, and socket fill.

Biological: Platelet-rich fibrin (PRF)

Split-Mouth Control Arm

NO INTERVENTION

Each participant will have two symmetrical tooth extractions. One socket will be randomly assigned to receive platelet-rich fibrin (PRF), and the contralateral socket will serve as a control, healing naturally without any graft material. This split-mouth design allows each participant to act as their own control. Radiographic assessments using cone-beam computed tomography (CBCT) will be conducted at baseline and 3 months to measure bone height, ridge width, and socket fill.

Interventions

Platelet-rich fibrin (PRF) BIOLOGICAL

Platelet-rich fibrin (PRF) is an autologous blood-derived material prepared by centrifuging the participant's venous blood without anticoagulants. The PRF clot is then compressed into a membrane and inserted into the extraction socket. It serves as a scaffold rich in platelets and growth factors to support bone regeneration and healing.

Split-Mouth PRF Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Smoking fewer than 10 cigarettes per day
• Presence of adequate bony support (≥ 60%)
• Indications for bilateral tooth extraction
• Patients classified as ASA I or II (American Society of Anesthesiologists).
• No systemic conditions known to impair healing, including the following:
• Use of bisphosphonates
• Anticoagulant or antiplatelet therapy
• History of head and neck radiotherapy
• Chronic use of NSAIDs or corticosteroids

You may not qualify if:

• Patients were excluded if they met any of the following conditions:
• ASA classification III or IV
• Pregnancy or lactation
• Presence of active infection at the surgical site or need for medications beyond standard analgesics
• Presence of chronic lesions at the extraction site (patients requiring curettage of the lesion were included; those with acute infection requiring antibiotics were excluded).

Sponsors & Collaborators

• Zahedan University of Medical Sciences: lead

Study Sites (1)

Zahedan University of Medical Sciences

Zahedan, Sistan & Balouchestan, Iran

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontics Resident

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 15, 2025
• Study Start: September 21, 2024
• Primary Completion: January 18, 2025
• Study Completion: January 18, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IR (1)