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CompletedNCT02707536Updated May 4, 2017

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

An interventional study of Socket grafting with PRF and Socket grafting with bone graft in Extraction Socket Healing and Alveolar Ridge Preservation, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled May 2014, registered Mar 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Extraction Socket Healing
  • Alveolar Ridge Preservation
03

In context

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • 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

  • Active comparator
    Socket grafting with bone grafting alone

    Extraction with socket grafting using bone graft (xenograft).

    Procedure: Socket grafting with 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 · Procedure: Socket grafting with bone graft

Interventions

  • ProcedureSocket grafting with PRF

    Extraction with socket grafting using PRF.

  • ProcedureSocket grafting with bone graft

    Extraction with socket grafting using bone graft.

06

What researchers measure

Primary outcomes

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

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

    Time frame: baseline, 3 months

  2. Change in alveolar ridge height (apical coronal)

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

    Time frame: baseline, 3 months

Secondary outcomes

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

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

    Time frame: 3 months

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

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

    Time frame: 3 months

07

Study locations

1 site
  • The University of Texas Health Science Center at Houston School of Dentistry
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02707536
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Sridhar V. K. Eswaran (Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Mar 14, 2016
Start date
May 2014
Primary completion
Mar 2016
Completion
May 2016
Last update
May 4, 2017

Study contacts

Sridhar Eswaran, BDS, MS, MSD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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