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

Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft: A Clinical, Radiographic and Histological Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Ridge Preservation; Extraction Socket Healing
• Intervention / Treatment: Procedure: Socket grafting with PRF; Procedure: Socket grafting with bone graft

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No socket grafting; Extraction with normal socket healing
Active Comparator: Socket grafting with platelet rich fibrin (PRF) alone; Extraction with socket grafting with platelet rich fibrin (PRF) alone.	Procedure: Socket grafting with PRF; Extraction with socket grafting using PRF.
Active Comparator: Socket grafting with bone grafting alone; Extraction with socket grafting using bone graft (xenograft).	Procedure: Socket grafting with bone graft; Extraction with socket grafting using bone graft.
Active Comparator: Socket grafting with PRF and bone grafting; Extraction with socket grafting using PRF combined with bone graft (xenograft).	Procedure: Socket grafting with PRF; Extraction with socket grafting using PRF.; Procedure: Socket grafting with bone graft; Extraction with socket grafting using bone graft.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of vital bone in bone core as assessed histology	A bone core will be taken at 3 months after socket grafting.	3 months
Percentage of residual bone graft in bone core as assessed histology	A bone core will be taken at 3 months after socket grafting.	3 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sridhar Eswaran, BDS, MS, MSD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 14, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HSC-DB-14-0190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO