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

Not Applicable

Completed

• Conditions: Socket Preservation
• Interventions: Biological: Platelet-rich fibrin (PRF)

• Registration Number: NCT07022860
• Lead Sponsor: Zahedan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-21
• Primary Completion: 2025-01-18
• Study Completion: 2025-01-18
• Status Verified: 2025-06
• Study First Submitted: 2025-06-07
• Study First Submitted QC: 2025-06-07
• Last Update Submitted: 2025-06-07
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Participants were eligible for inclusion if they met the following criteria:

• 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

Exclusion Criteria

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Split-Mouth PRF Arm	Platelet-rich fibrin (PRF)	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.

Primary Outcome Measures

Name	Time	Method
Change in Vertical Ridge Height from Baseline to 3 Months Post-Extraction as Measured by Cone-Beam Computed Tomography (CBCT)	Immediately post-extraction (baseline) and at 3 months post-extraction	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.

Secondary Outcome Measures

Name	Time	Method
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	Horizontal ridge width was measured at 1 mm, 3 mm, and 5 mm below the lingual/palatal crest using cone-beam computed tomography (CBCT). The change in width between baseline and 3 months post-extraction was calculated. Smaller changes indicate better preservation of ridge width. Measurements were made using standardized reference lines and a slice thickness of 1 mm.
Percentage of Socket Fill at 3 Months Post-Extraction as Measured by CBCT	3 months post-extraction	The percentage of socket fill was determined using CBCT imaging at 3 months post-extraction. Socket fill refers to the amount of mineralized bone formation within the extraction site. A higher percentage indicates greater bone regeneration. A blinded radiologist performed all measurements using pre-defined reference points and standardized protocols.

Trial Locations

Locations (1)

Zahedan University of Medical Sciences; 🇮🇷 Zahedan, Sistan & Balouchestan, Iran, Islamic Republic of