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

NCT ID: NCT02707536

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Extraction Socket Healing Alveolar Ridge Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No socket grafting

Extraction with normal socket healing

Group Type NO_INTERVENTION

No interventions assigned to this group

Socket grafting with platelet rich fibrin (PRF) alone

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

Group Type ACTIVE_COMPARATOR

Socket grafting with PRF

Intervention Type PROCEDURE

Extraction with socket grafting using PRF.

Socket grafting with bone grafting alone

Extraction with socket grafting using bone graft (xenograft).

Group Type ACTIVE_COMPARATOR

Socket grafting with bone graft

Intervention Type PROCEDURE

Extraction with socket grafting using bone graft.

Socket grafting with PRF and bone grafting

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

Group Type ACTIVE_COMPARATOR

Socket grafting with PRF

Intervention Type PROCEDURE

Extraction with socket grafting using PRF.

Socket grafting with bone graft

Intervention Type PROCEDURE

Extraction with socket grafting using bone graft.

Interventions

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Socket grafting with PRF

Extraction with socket grafting using PRF.

Intervention Type PROCEDURE

Socket grafting with bone graft

Extraction with socket grafting using bone graft.

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Sridhar V. K. Eswaran

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sridhar Eswaran, BDS, MS, MSD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-DB-14-0190

Identifier Type: -

Identifier Source: org_study_id

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