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OpenTrials
Completed

NCT Number: NCT02707536

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

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.

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Key information

Conditions

Extraction Socket Healing Alveolar Ridge Preservation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Socket grafting with PRF

Procedure

Extraction with socket grafting using PRF.

Socket grafting with bone graft

Procedure

Extraction with socket grafting using bone graft.

Primary outcomes

  1. Change in alveolar ridge width (buccal-lingual)

    Time frame: baseline, 3 months

    Baseline is at the time of extraction with or without socket grafting.

  2. Change in alveolar ridge height (apical coronal)

    Time frame: baseline, 3 months

    Baseline is at the time of extraction with or without socket grafting.

Secondary outcomes

  1. Percentage of vital bone in bone core as assessed histology

    Time frame: 3 months

    A bone core will be taken at 3 months after socket grafting.

  2. Percentage of residual bone graft in bone core as assessed histology

    Time frame: 3 months

    A bone core will be taken at 3 months after socket grafting.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2016
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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