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

Alveolar Ridge Preservation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707536
• Other study ID #: HSC-DB-14-0190
• Status: Completed
• Phase: N/A
• First received: March 9, 2016
• Last updated: May 2, 2017
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2017
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Ridge Preservation
• Extraction Socket Healing

Intervention

Procedure:
• Socket grafting with PRF
Extraction with socket grafting using PRF.
• Socket grafting with bone graft
Extraction with socket grafting using bone graft.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston School of Dentistry	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in alveolar ridge width (buccal-lingual)	Baseline is at the time of extraction with or without socket grafting.	baseline, 3 months
Primary	Change in alveolar ridge height (apical coronal)	Baseline is at the time of extraction with or without socket grafting.	baseline, 3 months
Secondary	Percentage of vital bone in bone core as assessed histology	A bone core will be taken at 3 months after socket grafting.	3 months
Secondary	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