Edentulous Alveolar RidgePhase 1/2NCT01929954
Safety Study of Gintuit™ in Subjects Requiring Socket Grafting
A Phase 1/2 study testing Gintuit and Bio-Gide in people with Edentulous Alveolar Ridge, run by Organogenesis at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Gintuit and Bio-Gide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kevin G. Murphy and Associates, P.A.
Baltimore, Maryland, 21209
About this study
Official title: 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).
Read the 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.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Gintuit, Bio-Gide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GintuitBiological
One time placement of Gintuit over socket graft.
Bio-GideDevice
One time placement of Bio-Gide over socket graft.
| Study group | Role | What they receive |
|---|---|---|
| Gintuit | Experimental | 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. Receives: Biological: Gintuit |
| Bio-Gide | Active comparator | 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. Receives: Device: Bio-Gide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: up to 12 months post treatment
Secondary outcomes (15)
Optimal product configuration (ie, single, folded, or z-folded)
Subjective assessment based on the results of the analyses of safety, efficacy and product handling (from surgeon input) data
Measured: One month after placement of Gintuit in the last subject in the last successful cohort
Number of participants reporting loose graft material
Measured: Up to 21 days post treatment
Percentage of participants with soft tissue closure
Measured: Up to 4 weeks post treatment
Measurements of bone height
Measured: Up to 6 months post treatment
Gintuit product handling
Rated as excellent, very good, good, adequate, poor
Measured: At Day 0
Number of participants with visible loss of graft material
Measured: Up to 3 months post treatment
Percentage of participants with convex, normal and concave soft tissue contour
Measured: Up to 6 months post treatment
Measurement of soft tissue ridge contour
Measured: Up to 6 months post treatment
Measurement of soft tissue thickness
Measured: Up to 6 months post treatment
Percentage of participants with color and texture match
Measured: Up to 6 months post treatment
Percentage of participants with a clinically significant physical reduction of crestal ridge height
Clinically significant defined as > 2 mm loss at the crest of the ridge at the graft site compared to Day 0
Measured: Up to 6 months post treatment
Measurements of soft tissue ridge height
Measured: Up to 6 months post treatment
Measurements of ridge width of hard tissue
Measured: Up to 6 months post treatment
Bone quality
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))
Measured: Up to 6 months post treatment
Percentage of participants with acceptable implant stability
Acceptable implant stability defined as an implant stability quotient of >/= 55
Measured: Up to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Changes in corporate business environment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin G. Murphy, DDS, MS, Principal investigator, Kevin G. Murphy Associates, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929954
- Sponsor's protocol ID
- 11-PER-005-GT
- Status last verified
- Sep 2015
- First submitted
- 13 Aug 2013
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2, Randomized, Controlled Assessment of the Safety Of Gintuit™ Versus Bio-Gide® in Subjects Requiring Socket Grafting
- ClinicalTrials.gov ID
- NCT01929954
- Acronym / sponsor ID
- 11-PER-005-GT
- Conditions
- Edentulous Alveolar Ridge
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes in corporate business environment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gintuit | Experimental | Biological: GintuitSubjects 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. |
| Bio-Gide | Active comparator | Device: Bio-GideSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GintuitOne time placement of Gintuit over socket graft. | Biological | Gintuit |
| Bio-GideOne time placement of Bio-Gide over socket graft. | Device | Bio-Gide |
Primary outcome
Number of participants with adverse events
Time frame: up to 12 months post treatment
15 secondary outcomes
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
Number of participants reporting loose graft material
Time frame: Up to 21 days post treatment
Percentage of participants with soft tissue closure
Time frame: Up to 4 weeks post treatment
Measurements of bone height
Time frame: Up to 6 months post treatment
Gintuit product handling
Time frame: At Day 0
Number of participants with visible loss of graft material
Time frame: 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
Measurement of soft tissue ridge contour
Time frame: Up to 6 months post treatment
Measurement of soft tissue thickness
Time frame: Up to 6 months post treatment
Percentage of participants with color and texture match
Time frame: 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
Measurements of soft tissue ridge height
Time frame: Up to 6 months post treatment
Measurements of ridge width of hard tissue
Time frame: Up to 6 months post treatment
Bone quality
Time frame: Up to 6 months post treatment
Percentage of participants with acceptable implant stability
Time frame: Up to 12 months post treatment
Results and safety
The study was stopped early (reason given: Changes in corporate business environment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin G. Murphy, DDS, MS principal investigator
Kevin G. Murphy Associates, P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gintuit and Bio-Gide in people with Edentulous Alveolar Ridge, run by Organogenesis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Changes in corporate business environment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: up to 12 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.