Safety Study of Gintuit™ in Subjects Requiring Socket Grafting

September 23, 2015 updated by: Organogenesis

Phase 1/2, Randomized, Controlled Assessment of the Safety Of Gintuit™ Versus Bio-Gide® in Subjects Requiring Socket Grafting

This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring extraction. The incidence and severity of adverse events will be summarized by group (GINTUIT and Bio-Gide).

Study Overview

Status

Status

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

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

This study will evaluate the safety of GINTUIT as compared with Bio-Gide in subjects who have a posterior tooth requiring extraction. The use of GINTUIT in this investigational clinical indication may eliminate/reduce the need for aggressive flap advancement with its concomitant morbidity, while, at the same time, obtaining stable closure over a grafted socket. It is anticipated that GINTUIT will facilitate tissue granulation, followed by tissue coverage with site appropriate tissue (ie, keratinized tissue) that is needed for long term stability of the final restoration.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

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.
  • Phase 2
  • Phase 1

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
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Kevin G. Murphy and Associates, P.A.

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is at least 18 years of age but no more than 75 years of age.
  • Subject has a posterior (molar or premolar) socket created by atraumatic extraction with a post extraction socket of a minimum of 5 mm in both the mesial-distal (M-D) and buccal-lingual (B-L) dimensions that requires bone grafting.
  • Subject has sufficient buccal bone plate at the site of the planned tooth extraction (ie, the residual socket should be of a form that would retain bone graft material), as judged by the Principal Investigator.
  • Females of childbearing potential must have a documented negative urine pregnancy test. All subjects must agree to use acceptable methods of contraception for the duration of the study.
  • Subjects must have read, understood, and signed an institutional review board (IRB)-approved Informed Consent Form (ICF).
  • Subjects must be able and willing to comply with protocol requirements.

Exclusion Criteria:

  • Subject with any systemic conditions that could compromise wound healing and preclude periodontal surgery (ie, bleeding disorder, cancer, except localized basal cell or squamous cell cancer of the skin with no metastasis; human immunodeficiency virus; or bone metabolic diseases [ie, osteoporosis or Paget's disease]).
  • Subject who is currently receiving, anticipates receiving or has received within 30 days prior to Day 0: inhaled or systemic corticosteroids (ie, oral, IV), immunosuppressive agents or radiation therapy, and/or chemotherapy, which could compromise wound healing and preclude periodontal surgery.
  • Subject who has had oral/periodontal surgery within 30 days prior to Day 0 or anticipates having oral/periodontal surgery within 30 days after Day 0.
  • Subject with acute mucosal infection, including suppuration or induration in the area of intended surgery.
  • Subject, who in the opinion of the Principal Investigator, will require a sinus lift procedure to place dental implants in the surgical area.
  • Subject without at least 1 tooth adjacent to the area to be treated.
  • Subject has a history of alcohol or substance abuse within the previous 12 months of Screening that could interfere with study compliance or protocol requirements.
  • Subject who has used any tobacco product within 6 months of Screening.
  • Subject with known hypersensitivity to porcine or bovine collagen, gentamicin or surfactants.
  • Subject who has received an investigational drug, device, or biological/bioactive treatment within 30 days prior to Day 0 (medical or dental).
  • Subject who was previously treated with Gintuit, or any other cell therapy at the target treatment site or immediately adjacent teeth.
  • Female subject that is lactating.
  • Subject, who in the opinion of the Principal Investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

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: Parallel Assignment
  • Masking: None (Open Label)

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: Gintuit
Subjects with a posterior tooth (molar or premolar) socket created by atraumatic extraction will be grafted with freeze-dried bone allograft (ie, MinerOss™). The primary wound bed will consist of exposed alveolar bone and bone graft imbedded in coagulum of blood from the socket for both treatments. The test treatment GINTUIT will be inlayed within the defect over the socket graft material, and stabilized with resorbable tacking sutures. An additional single layer of GINTUIT will cover the entire surface of the extraction socket at approx. 2-3 mm beyond the margins of the wound and fixed with non-resorbable sutures. The lower layer of this additional layer should be in contact with the previously applied GINTUIT.
Biological: Gintuit
One time placement of Gintuit over socket graft.
Active Comparator: Bio-Gide
Subjects with a posterior tooth (molar or premolar) socket created by atraumatic extraction will be grafted with freeze-dried bone allograft (ie, MinerOss™). The primary wound bed will consist of exposed alveolar bone and bone graft imbedded in coagulum of blood from the socket for both treatments. The control treatment will be a collagen membrane (ie, Bio-Gide, applied per the Package Insert) inlayed within the defect over the socket graft material, and stabilized with resorbable tacking sutures. Crossed suspensory type sutures should also be placed over Bio-Gide, depending on the degree of stabilization needed. In all subjects, care should be taken in suturing to avoid advancement of the buccal gingival flap.
Device: Bio-Gide
One time placement of Bio-Gide over socket graft.

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
Time Frame
Number of participants with adverse events
Time Frame: up to 12 months post treatment
up to 12 months post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Optimal product configuration (ie, single, folded, or z-folded)
Time Frame: One month after placement of Gintuit in the last subject in the last successful cohort
Subjective assessment based on the results of the analyses of safety, efficacy and product handling (from surgeon input) data
One month after placement of Gintuit in the last subject in the last successful cohort
Number of participants reporting loose graft material
Time Frame: Up to 21 days post treatment
Up to 21 days post treatment
Percentage of participants with soft tissue closure
Time Frame: Up to 4 weeks post treatment
Up to 4 weeks post treatment
Measurements of bone height
Time Frame: Up to 6 months post treatment
Up to 6 months post treatment
Gintuit product handling
Time Frame: At Day 0
Rated as excellent, very good, good, adequate, poor
At Day 0
Number of participants with visible loss of graft material
Time Frame: Up to 3 months post treatment
Up to 3 months post treatment
Percentage of participants with convex, normal and concave soft tissue contour
Time Frame: Up to 6 months post treatment
Up to 6 months post treatment
Measurement of soft tissue ridge contour
Time Frame: Up to 6 months post treatment
Up to 6 months post treatment
Measurement of soft tissue thickness
Time Frame: Up to 6 months post treatment
Up to 6 months post treatment
Percentage of participants with color and texture match
Time Frame: Up to 6 months post treatment
Up to 6 months post treatment
Percentage of participants with a clinically significant physical reduction of crestal ridge height
Time Frame: Up to 6 months post treatment
Clinically significant defined as > 2 mm loss at the crest of the ridge at the graft site compared to Day 0
Up to 6 months post treatment
Measurements of soft tissue ridge height
Time Frame: Up to 6 months post treatment
Up to 6 months post treatment
Measurements of ridge width of hard tissue
Time Frame: Up to 6 months post treatment
Up to 6 months post treatment
Bone quality
Time Frame: Up to 6 months post treatment
Regularity and density of the cortical and trabecular bone using the system described by Norton and Gamble (Quality Levels 1, 2/3, 4 and 4 (failure zone))
Up to 6 months post treatment
Percentage of participants with acceptable implant stability
Time Frame: Up to 12 months post treatment
Acceptable implant stability defined as an implant stability quotient of >/= 55
Up to 12 months post treatment

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.
Organogenesis

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: Kevin G. Murphy, DDS, MS, Kevin G. Murphy Associates, P.A.

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

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.
July 1, 2013

Primary Completion (Actual)

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.
March 1, 2015

Study Completion (Actual)

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.
March 1, 2015

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).
August 13, 2013

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.
August 22, 2013

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.
August 28, 2013

Study Record Updates

Last Update Posted (Estimate)

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.
September 24, 2015

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.
September 23, 2015

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.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 11-PER-005-GT

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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