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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT02707536

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extraction Socket Healing Alveolar Ridge Preservation	Procedure: Socket grafting with PRF Procedure: Socket grafting with bone graft	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Extraction with socket grafting using PRF.
Active Comparator: Socket grafting with bone grafting alone Extraction with socket grafting using bone graft (xenograft).	Procedure: Socket grafting with bone graft Extraction with socket grafting using 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 Extraction with socket grafting using PRF. Procedure: Socket grafting with bone graft Extraction with socket grafting using bone graft.

Outcome Measures

Primary Outcome Measures

Change in alveolar ridge width (buccal-lingual) [baseline, 3 months]
Baseline is at the time of extraction with or without socket grafting.
Change in alveolar ridge height (apical coronal) [baseline, 3 months]
Baseline is at the time of extraction with or without socket grafting.

Secondary Outcome Measures

Percentage of vital bone in bone core as assessed histology [3 months]
A bone core will be taken at 3 months after socket grafting.
Percentage of residual bone graft in bone core as assessed histology [3 months]
A bone core will be taken at 3 months after socket grafting.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston School of Dentistry	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator: Sridhar Eswaran, BDS, MS, MSD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sridhar V. K. Eswaran, Assistant Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT02707536

Other Study ID Numbers:

HSC-DB-14-0190

First Posted:

Mar 14, 2016

Last Update Posted:

May 4, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of May 4, 2017