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Clinical Trials/NCT07022860
NCT07022860CompletedNot Applicable

Radiographic Assessment of the Effects of Platelet-Rich Fibrin on Socket Preservation: A Case-Control Study

Zahedan University of Medical Sciences1 site in 1 country12 target enrollmentStarted: September 21, 2024Last updated:
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
Change in Vertical Ridge Height from Baseline to 3 Months Post-Extraction as Measured by Cone-Beam Computed Tomography (CBCT)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

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.

Intervention: Platelet-rich fibrin (PRF) (Biological)

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
Zahedan University of Medical Sciences
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alireza Ranjbaran

Periodontics Resident

Zahedan University of Medical Sciences

Study Sites (1)

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