Gingival RecessionNCT01547962
A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva
A study testing Gintuit and autologous Free Gingival Graft (FGG) in people with Gingival Recession, run by Organogenesis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a free autogenous graft using donor tissue harvested from the subject's palate in the treatment of subjects who have an insufficient zone of attached gingiva associated with at least two non adjacent teeth. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Gintuit and autologous Free Gingival Graft (FGG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2006
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or older at the time of enrollment, and not older than seventy years.
- Subject has at least two non-adjacent teeth with an insufficient zone of attached gingiva which requires soft tissue grafting. The two selected teeth must be located in contralateral quadrants. (In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but both teeth will get the same treatment).
- Root coverage is not desired or indicated at the time of grafting.
- Females of childbearing potential must have a documented negative urine or serum pregnancy test.
- Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
- Subjects must be able and willing to follow study procedures and instructions.
Who cannot join
- Teeth that have an insufficient zone of attached gingiva that would be best treated using soft tissue grafts, which would attempt to cover the denuded root surface.
- Subjects with any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) which could compromise wound healing and preclude periodontal surgery.
- Subjects who are currently receiving or have received within one week prior to study entry, systemic corticosteroids (including inhaled), immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- Subjects with the presence of acute infectious lesions in the areas intended for surgery.
- Subjects who smoke.
- Teeth requiring treatment are molars.
Show all 12Show fewer
- Teeth with axial mobility.
- Known hypersensitivity to bovine collagen.
- Subjects enrolled in medical, dental, or any investigational device study for any disease within the past four weeks.
- Subjects who have received an investigational drug or biological treatment within the three months prior to study enrollment (medical or dental).
- Subjects previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s).
- Subjects who, in the opinion of the 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.
About this study
Official title: A Pilot Clinical Trial to Assess the Safety and Efficacy of Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) in Establishing a Functional Zone of Attached Gingiva
The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a free autogenous graft using donor tissue harvested from the subject's palate in the treatment of subjects who have an insufficient zone of attached gingiva associated with at least two non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment and control in the change in amount of attached gingiva over the 6 month observation period.
Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft will be placed in the other. The grafts will be evaluated clinically to determine the change in the amount of attached gingiva and on at least three subjects, a small biopsy will be taken to allow histologic evaluation and comparison of both grafts.
- Conditions
- Gingival Recession
- Being tested
- Gintuit, autologous Free Gingival Graft (FGG)
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GintuitDevice
Gintuit is prepared in a "S" fold and trimmed to fit the prepared wound bed, with a standardized width of 5 mm and sutured in place with a 5/0 gut suture.
autologous Free Gingival Graft (FGG)Other
Autologous FGG harvested from the subject's palate, the width of the FGG will be 5 mm and sutured in place with a 5/0 gut suture.
| Study group | Role | What they receive |
|---|---|---|
| Split-mouth design: Treatment | Experimental | Not described Receives: Device: Gintuit |
| Split-mouth design: Control | Active comparator | Not described Receives: Other: autologous Free Gingival Graft (FGG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of attached gingiva
Change in the amount of attached gingiva
Measured: 6 months
Secondary outcomes (9)
Inflammation
Change from baseline in inflammation score
Measured: week 1, week 4, month 3 and month 6
Color of grafted tissue
Color match of the grafted tissue to the adjacent tissue
Measured: 4 weeks, 3 months, 6 months
Texture of grafted tissue
Texture match of the grafted tissue to the adjacent tissue
Measured: 4 weeks, 3 months, 6 months
Oral muscle pull
Resistance to oral muscle pull
Measured: 6 months
Probing depth
Change in probing depth from baseline
Measured: 6 months
Clinical attachment level (ie, distance from the cemento-enamel junction (CEJ; or another definite chosen landmark) to the base of the sulcus or periodontal pocket)
Change in clinical attachment level (mm) from baseline
Measured: 6 months
Overall Subject Preference
VAS scale subject assessment of each treated site with anchors of "disappointed" and "fully satisfied".
Measured: 6 months
Recession depth
Change in recession depth
Measured: 3 months, 6 months
Keratinized tissue
Width of keratinized tissue
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startSep 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547962
- Sponsor's protocol ID
- 05-PER-001
- Status last verified
- Apr 2012
- First submitted
- 28 Feb 2012
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
McGuire MK, Scheyer ET, Nunn ME, Lavin PT. A pilot study to evaluate a tissue-engineered bilayered cell therapy as an alternative to tissue from the palate. J Periodontol. 2008 Oct;79(10):1847-56. doi: 10.1902/jop.2008.080017.
PubMed 18834238
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial to Assess the Safety and Efficacy of Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) in Establishing a Functional Zone of Attached Gingiva
- ClinicalTrials.gov ID
- NCT01547962
- Acronym / sponsor ID
- 05-PER-001
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 8 Mar 2012 (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.
The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a free autogenous graft using donor tissue harvested from the subject's palate in the treatment of subjects who have an insufficient zone of attached gingiva associated with at least two non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment and control in the change in amount of attached gingiva over the 6 month observation period.
Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft will be placed in the other. The grafts will be evaluated clinically to determine the change in the amount of attached gingiva and on at least three subjects, a small biopsy will be taken to allow histologic evaluation and comparison of both grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split-mouth design: Treatment | Experimental | Device: Gintuit |
| Split-mouth design: Control | Active comparator | Other: autologous Free Gingival Graft (FGG) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is 18 years of age or older at the time of enrollment, and not older than seventy years.
- Subject has at least two non-adjacent teeth with an insufficient zone of attached gingiva which requires soft tissue grafting. The two selected teeth must be located in contralateral quadrants. (In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but both teeth will get the same treatment).
- Root coverage is not desired or indicated at the time of grafting.
- Females of childbearing potential must have a documented negative urine or serum pregnancy test.
- Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
Key exclusion criteria (12 listed)
- Teeth that have an insufficient zone of attached gingiva that would be best treated using soft tissue grafts, which would attempt to cover the denuded root surface.
- Subjects with any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) which could compromise wound healing and preclude periodontal surgery.
- Subjects who are currently receiving or have received within one week prior to study entry, systemic corticosteroids (including inhaled), immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- Subjects with the presence of acute infectious lesions in the areas intended for surgery.
- Subjects who smoke.
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 |
|---|---|---|
| GintuitGintuit is prepared in a "S" fold and trimmed to fit the prepared wound bed, with a standardized width of 5 mm and sutured in place with a 5/0 gut suture. | Device | Split-mouth design: Treatment |
| autologous Free Gingival Graft (FGG)Autologous FGG harvested from the subject's palate, the width of the FGG will be 5 mm and sutured in place with a 5/0 gut suture. | Other | Split-mouth design: Control |
Primary outcome
Amount of attached gingiva
Time frame: 6 months
Change in the amount of attached gingiva
9 secondary outcomes
Inflammation
Time frame: week 1, week 4, month 3 and month 6
Color of grafted tissue
Time frame: 4 weeks, 3 months, 6 months
Texture of grafted tissue
Time frame: 4 weeks, 3 months, 6 months
Oral muscle pull
Time frame: 6 months
Probing depth
Time frame: 6 months
Clinical attachment level (ie, distance from the cemento-enamel junction (CEJ; or another definite chosen landmark) to the base of the sulcus or periodontal pocket)
Time frame: 6 months
Overall Subject Preference
Time frame: 6 months
Recession depth
Time frame: 3 months, 6 months
Keratinized tissue
Time frame: 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
- Results publication: PubMed 18834238McGuire MK, Scheyer ET, Nunn ME, Lavin PT. A pilot study to evaluate a tissue-engineered bilayered cell therapy as an alternative to tissue from the palate. J Periodontol. 2008 Oct;79(10):1847-56. doi: 10.1902/jop.2008.080017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gintuit and autologous Free Gingival Graft (FGG) in people with Gingival Recession, 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 12 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: finished, as of the sponsor's last update on 9 Apr 2012. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of attached gingiva (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547962, which also lists 1 linked publication.
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 9 Apr 2012.