Safety Study of Gintuit™ in Subjects Requiring Socket Grafting

Edentulous Alveolar Ridge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01929954
• Other study ID #: 11-PER-005-GT
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 13, 2013
• Last updated: September 23, 2015
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Organogenesis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge

Intervention

Biological:
• Gintuit
One time placement of Gintuit over socket graft.

Device:
• Bio-Gide
One time placement of Bio-Gide over socket graft.

Locations

Country	Name	City	State
United States	Kevin G. Murphy and Associates, P.A.	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		up to 12 months post treatment	Yes
Secondary	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	One month after placement of Gintuit in the last subject in the last successful cohort	No
Secondary	Number of participants reporting loose graft material		Up to 21 days post treatment	Yes
Secondary	Percentage of participants with soft tissue closure		Up to 4 weeks post treatment	No
Secondary	Measurements of bone height		Up to 6 months post treatment	No
Secondary	Gintuit product handling	Rated as excellent, very good, good, adequate, poor	At Day 0	No
Secondary	Number of participants with visible loss of graft material		Up to 3 months post treatment	Yes
Secondary	Percentage of participants with convex, normal and concave soft tissue contour		Up to 6 months post treatment	No
Secondary	Measurement of soft tissue ridge contour		Up to 6 months post treatment	No
Secondary	Measurement of soft tissue thickness		Up to 6 months post treatment	No
Secondary	Percentage of participants with color and texture match		Up to 6 months post treatment	No
Secondary	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	Up to 6 months post treatment	No
Secondary	Measurements of soft tissue ridge height		Up to 6 months post treatment	No
Secondary	Measurements of ridge width of hard tissue		Up to 6 months post treatment	No
Secondary	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))	Up to 6 months post treatment	No
Secondary	Percentage of participants with acceptable implant stability	Acceptable implant stability defined as an implant stability quotient of >/= 55	Up to 12 months post treatment	No