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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02707536
Other study ID # HSC-DB-14-0190
Secondary ID
Status Completed
Phase N/A
First received March 9, 2016
Last updated May 2, 2017
Start date May 2014
Est. completion date May 2016

Study information

Verified date May 2017
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Socket grafting with PRF
Extraction with socket grafting using PRF.
Socket grafting with bone graft
Extraction with socket grafting using bone graft.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston School of Dentistry Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in alveolar ridge width (buccal-lingual) Baseline is at the time of extraction with or without socket grafting. baseline, 3 months
Primary Change in alveolar ridge height (apical coronal) Baseline is at the time of extraction with or without socket grafting. baseline, 3 months
Secondary Percentage of vital bone in bone core as assessed histology A bone core will be taken at 3 months after socket grafting. 3 months
Secondary Percentage of residual bone graft in bone core as assessed histology A bone core will be taken at 3 months after socket grafting. 3 months
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