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

NCT02707536 | Completed

• 1 other identifier: HSC-DB-14-0190
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Extraction Socket Healing; Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Percentage of vital bone in bone core as assessed histology

  3 months

• Percentage of residual bone graft in bone core as assessed histology

  3 months

Study Arms (4)

No socket grafting

NO INTERVENTION

Extraction with normal socket healing

Socket grafting with platelet rich fibrin (PRF) alone

ACTIVE COMPARATOR

Extraction with socket grafting with platelet rich fibrin (PRF) alone.

Procedure: Socket grafting with PRF

Socket grafting with bone grafting alone

ACTIVE COMPARATOR

Extraction with socket grafting using bone graft (xenograft).

Procedure: Socket grafting with bone graft

Socket grafting with PRF and bone grafting

ACTIVE COMPARATOR

Extraction with socket grafting using PRF combined with bone graft (xenograft).

Procedure: Socket grafting with PRF; Procedure: Socket grafting with bone graft

Interventions

Socket grafting with PRF PROCEDURE

Extraction with socket grafting using PRF.

Socket grafting with PRF and bone grafting; Socket grafting with platelet rich fibrin (PRF) alone

Socket grafting with bone graft PROCEDURE

Extraction with socket grafting using bone graft.

Socket grafting with PRF and bone grafting; Socket grafting with bone grafting alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston School of Dentistry

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone; Bone Transplantation

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Sridhar Eswaran, BDS, MS, MSD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 14, 2016
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)