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The Impact of a Known Bioactive Agent on the Resolution of Alveolar Socket Preservation

NCT02802436 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-07-05

No results posted yet for this study

Summary

The advent of endosseous implant restoration has driven an increasing need for alveolar bone preservation and/or augmentation strategies. Investigations have explored the physical scaffold effects of a wide variety of bone graft materials with each graft material offering a more or less attractive surface for bone deposition. The seeding of these scaffolds with biologically active material seeks to enhance the "osteoconductive" effect by influencing the temporal or sequential steps which result in the desired end product-new bone.

Alveolar socket grafts are a common example of these preservation techniques. They are an accepted procedure to maximize the retention of alveolar bone post extraction. They appear to act as a passive scaffold for clot retention and subsequent bone regeneration.

The current pilot research project explores addition of a known Bioactive Agent: Platelet Derived Growth Factor (PDGF) to test its impact on healing responses. Histomorphometric assessments will be utilized on microscopic slide material derived from cores trephined as the initial step in the preparation for placement of endosseous dental implants. Outcomes measured will include:

Clinical observation of healing response

Microscopic measures will be

* Measures of residual graft material
* New bone formation and new bone contact area with graft
* Measures of vascular content
* Osteoclast count
* Qualitative measures of other marrow components (Cells and relative fiber/ fat content, liner cell characteristics.)

Conditions

  • Healing of Extraction Socket

Interventions

PROCEDURE

Extraction with socket graft

Extraction will be done as usual standard of care to preserve socket walls. Sockets will be measured at all 4 line angles for depth with the same periodontal probe, Buccal-Lingual dimension will be measured prior to graft placement. Graft material (mineralized cortical/cancellous Bone Powder 250-1000µ) will be used for both sites. Volume of graft used will be recorded. Both sites will be filled slightly below marginal bone level (1mm). Test site will be injected with Bioactive Agent. At 3 levels apical 1/3rd, middle 1/3rd and coronal 1/3rd. Control site will be injected with saline (or vehicle) at same levels. Occlusal orifice will be closed with Collagen plug adjusted for depth to meet free gingival margins and then sutured with 4-0 PGA (Vicryl)

Sponsors & Collaborators

  • OsteoHealth

    collaborator UNKNOWN

  • Boston University

    lead OTHER

Principal Investigators

  • Sunny K Tilwani, BDS · Boston University Dental School

  • Albert Price, DMD · Boston University Dental School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-03
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02802436 on ClinicalTrials.gov