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

NCT02802436 | Withdrawn

• 1 other identifier: H34663
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Implant/core acquisition at time of Implant placement

  Site will be opened with standard full thickness flap entry. After soft tissue reflection photograph will be taken and implant site marked with a standardized round bur to ½ depth of bur (\~ 0.5-1.0 mm). Sites requiring a 4, 5, or 6mm implant will have trephined core as first step in osteotomy (3.3mm OD-2-8mmID) Trephine will be centered over site mark and osteotomy and prepared to prescribed depth. The trephine core will be photographed with periodontal probe included for reference of length, apical end marked with India ink and then placed in 10% neutral buffered formalin (NBF) and labeled with patient name, date, record # and length of core. Details of implant placement will be recorded with size of implant and insertion torque in record.

  3 months

Study Arms (2)

Extraction with socket graft and GEM21

EXPERIMENTAL

Intervention - Extraction will be done as usual standard of care to preserve socket walls. Graft material (mineralized cortical/cancellous Bone Powder 250-1000µ) will be used, site will be filled slightly below marginal bone level (1mm). Test site (active arm) will be injected with Bioactive Agent (PDGF - Platelet derived growth factor). At 3 levels apical 1/3rd, middle 1/3rd and coronal 1/3rd. Bioactive agent - GEM21S (Growth factor enhanced matrix) Dosage - one cup containing 0.5 cc of ß-TCP particles (0.25 to 1.0 mm); and one syringe containing a solution of 0.5 mL rhPDGF-BB (0.3 mg/mL)

Procedure: Extraction with socket graft

Extraction with socket graft

OTHER

Extraction will be done as usual standard of care to preserve socket walls. Graft material (mineralized cortical/cancellous Bone Powder 250-1000µ) will be used, site will be filled slightly below marginal bone level (1mm). Normal saline will be used and no growth factor to maintain the volume in control sites

Procedure: Extraction with socket graft

Interventions

Extraction with socket graft PROCEDURE

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)

Extraction with socket graft; Extraction with socket graft and GEM21

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be selected from the pool of periodontal patients at BUSDM (Boston University School of Dental Medicine) who have been treatment planned for at least two extractions which will be atleast one tooth apart in either arch (maxilla or mandible) followed by delayed 3-4 months dental implant placement.
• Subjects will be in age group 20-80 years of age.

You may not qualify if:

• Patients with known systemic disorders affecting bone Example - Osteoporosis, Diabetes Mellitus, Hyperthyroidism, Arthritis, smokers and pregnant women will be excluded.
• Untreated acute infections at the surgical site
• Untreated malignant neoplasm(s) at the surgical site
• Patients with a known hypersensitivity to any product component (ß-TCP = Tri calcium phosphate or rhPDGF-BB = Platelet derived growth factor)

Sponsors & Collaborators

• Boston University: lead
• OsteoHealth: collaborator

Study Sites (1)

Henry M. Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

• Albrektsson T, Johansson C. Osteoinduction, osteoconduction and osseointegration. Eur Spine J. 2001 Oct;10 Suppl 2(Suppl 2):S96-101. doi: 10.1007/s005860100282.

  PMID: 11716023 RESULT

• Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.

  PMID: 16332231 RESULT

• Jayakumar A, Rajababu P, Rohini S, Butchibabu K, Naveen A, Reddy PK, Vidyasagar S, Satyanarayana D, Pavan Kumar S. Multi-centre, randomized clinical trial on the efficacy and safety of recombinant human platelet-derived growth factor with beta-tricalcium phosphate in human intra-osseous periodontal defects. J Clin Periodontol. 2011 Feb;38(2):163-72. doi: 10.1111/j.1600-051X.2010.01639.x. Epub 2010 Dec 6.

  PMID: 21133980 RESULT

MeSH Terms

Interventions

socket graft

Study Officials

• Sunny K Tilwani, BDS

  Boston University Dental School

  PRINCIPAL INVESTIGATOR

• Albert Price, DMD

  Boston University Dental School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 16, 2016
• Study Start: October 3, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)