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

July 2, 2018 updated by: Boston University

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.)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Design: Split mouth RCT (Randomized controlled trial) Graft Procedure: At time of extraction the site will be asked to rinse with 0.12% Chlorhexidine, and anesthetized with 2% lidocaine and 1/100,000 epinephrine. Extraction will be done as usual standard of care to preserve socket walls. Sites requiring socket wall repair at time of extraction will be excluded from study. 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 Polyglactin (Vicryl)

Post op care: Sites will be checked and photographed at 1 week, 2 weeks (sutures removed) and clinical photos taken to monitor clinical signs of inflammation and healing. A 3-month post op radiograph appointment will be made at the 2-week visit. Ct scan may be taken if prescribed by treatment plan/ prior to implant placement.

Implant/core acquisition at time of Implant placement: Clinical photographs will be taken. (Post graft radiograph already done at 3 months) Site will be opened with standard full thickness flap entry. After soft tissue reflection photo 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.

Post-implant care: Standard of care post op sequence will be followed, once adequate healing period has elapsed healing cap that was screwed onto the implant is removed and replaced with appropriately shaped abutment. The entire procedure will be photographed and the usual post abutment radiograph will be taken at that time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Henry M. Goldman School of Dental Medicine, Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Extraction with socket graft and GEM21

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 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)
Other: Extraction with socket graft
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
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implant/core acquisition at time of Implant placement
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
OsteoHealth

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sunny K Tilwani, BDS, Boston University Dental School
  • Study Chair: Albert Price, DMD, Boston University Dental School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H34663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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