Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft

Not Applicable

Completed

• Conditions: Extraction Socket Healing; Alveolar Ridge Preservation
• Interventions: Procedure: Socket grafting with bone graft; Procedure: Socket grafting with PRF

• Registration Number: NCT02707536
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in extraction socket healing with or without particulate bone graft. The hypothesis of this study is that PRF will enhance the extraction socket healing and new bone formation when compared to extraction sockets grafted without PRF.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2016-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-14
• Study Completion: 2016-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Subjects ≥ 18 years of age
• Hopeless or non-restorable single non-molar tooth per quadrant with adjacent teeth present
• Maximum of two teeth can qualify per patient.
• The buccal plate must be ≥ 1mm in width with a 4-wall configuration.
• Cases requiring minimal sinus grafting (<3mm)
• Bone grafting limited to the apical portion of the osteotomy site

Exclusion Criteria

• Exclusion Criteria:
• Untreated periodontal disease, endodontic-periodontal disease and/or caries
• The buccal plate must be ≤ 3mm in width with a 4-wall configuration.
• Patients with uncontrolled or severe systemic disease (Diabetes)
• Patients with medical conditions or taking medication associated with compromised bone healing (Diabetes, Autoimmune Dysfunction, Prolonged Cortisone Therapy, Chemotherapy, or Bisphosphonate Therapy)
• Current Smokers
• Subjects with extensive parafunctional habits (ie; bruxism)
• Subjects who demonstrate inadequate oral hygiene

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Socket grafting with bone grafting alone	Socket grafting with bone graft	Extraction with socket grafting using bone graft (xenograft).
Socket grafting with PRF and bone grafting	Socket grafting with PRF	Extraction with socket grafting using PRF combined with bone graft (xenograft).
Socket grafting with PRF and bone grafting	Socket grafting with bone graft	Extraction with socket grafting using PRF combined with bone graft (xenograft).
Socket grafting with platelet rich fibrin (PRF) alone	Socket grafting with PRF	Extraction with socket grafting with platelet rich fibrin (PRF) alone.

Primary Outcome Measures

Name	Time	Method
Change in alveolar ridge width (buccal-lingual)	baseline, 3 months	Baseline is at the time of extraction with or without socket grafting.
Change in alveolar ridge height (apical coronal)	baseline, 3 months	Baseline is at the time of extraction with or without socket grafting.

Secondary Outcome Measures

Name	Time	Method
Percentage of residual bone graft in bone core as assessed histology	3 months	A bone core will be taken at 3 months after socket grafting.
Percentage of vital bone in bone core as assessed histology	3 months	A bone core will be taken at 3 months after socket grafting.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston School of Dentistry; 🇺🇸 Houston, Texas, United States