Gingival RecessionPhase 1/2NCT00679081
A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage
A Phase 1/2 study testing CelTx and Autologous sub-epithelial connective tissue graft in people with Gingival Recession, run by Organogenesis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. 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?
- CelTx and Autologous sub-epithelial connective tissue graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 at least 18 years of age but no more than 70 years of age.
- Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with Miller Class I or II buccal recession (≥ 3 mm) that requires soft tissue grafting. (Teeth may be treated with a maximum difference of 2 mm with respect to depth and width).
- Females of childbearing potential must have a documented negative urine pregnancy test and must agree to continue acceptable methods of contraception for 6 months post surgery.
- Subjects must have read, understood and signed an institutional review board (IRB)-approved Informed Consent Form (ICF).
- Subjects must be able and willing to follow study procedures and instructions.
Who cannot join
- Subject has extremely prominent root surfaces (> 1/2 the diameter of the root facial to cortical plate).
- Subject has interproximal attachment loss beyond the CEJ.
- Subject with teeth that have a Miller Grade 2 or higher mobility.
- Subjects with Class V restorations.
- Subjects with crowns on the teeth selected for treatment.
- Subjects who have had endodontic therapy in the last 6 months on the teeth selected for treatment.
Show all 18Show fewer
- Subjects who have used any tobacco product within the past 3 months.
- Subjects with only molar teeth suitable for soft tissue grafting.
- Subject has probing pocket depth >/= 4 mm at either surgical site.
- Female subjects who are pregnant or lactating.
- Subjects with any systemic conditions (i.e., uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and preclude periodontal surgery.
- Subjects who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- Subjects with the presence of acute infectious lesions.
- Subjects taking intramuscular or intravenous bisphosphonates.
- Subjects with a known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
- Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
- Subjects previously treated with Apligraf/CelTx, Dermagraft or any other cell-based product, including autologous tissue at the target site(s) or immediately adjacent teeth.
- 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.
United States1 site
Perio Health Professionals, PLLC
Houston, Texas, 77063
About this study
Official title: A Prospective, Randomized, Controlled Pilot Study of CelTx(TM) (Apligraf®) as an Alternative to Tissue From the Palate in the Treatment of Gingival Recession Requiring Root Coverage
The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.
- Conditions
- Gingival Recession
- Being tested
- CelTx, Autologous sub-epithelial connective tissue graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelTxDevice
Single application; split-mouth design
Autologous sub-epithelial connective tissue graftOther
Single application; split-mouth design
| Study group | Role | What they receive |
|---|---|---|
| CelTx | Experimental | CelTx Receives: Device: CelTx |
| Autologous CTG | Active comparator | Autologous sub-epithelial connective tissue graft Receives: Other: Autologous sub-epithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Rate of Adverse Events (AEs)
Adverse events were collected at every visit throughout the 6 month duration.
An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.
Measured: 6-month
Secondary outcomes (4)
Periodontal Health Measures
Measured: 6-months
Aesthetic Measures
Measured: 6-months
Post-Surgical Subject Comfort Measures
Measured: 4-weeks
Subject Preference Measures
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael McGuire, DDS, Principal investigator, Perio Health Professionals, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679081
- Sponsor's protocol ID
- 07-PER-004-CTX
- Status last verified
- Jan 2012
- First submitted
- 14 May 2008
- Last updated
- 11 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Pilot Study of CelTx(TM) (Apligraf®) as an Alternative to Tissue From the Palate in the Treatment of Gingival Recession Requiring Root Coverage
- ClinicalTrials.gov ID
- NCT00679081
- Acronym / sponsor ID
- 07-PER-004-CTX
- Conditions
- Gingival Recession
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Posted 21 Nov 2011
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 CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CelTx | Experimental | Device: CelTxCelTx |
| Autologous CTG | Active comparator | Other: Autologous sub-epithelial connective tissue graftAutologous sub-epithelial connective tissue graft |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is at least 18 years of age but no more than 70 years of age.
- Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with Miller Class I or II buccal recession (≥ 3 mm) that requires soft tissue grafting. (Teeth may be treated with a maximum difference of 2 mm with respect to depth and width).
- Females of childbearing potential must have a documented negative urine pregnancy test and must agree to continue acceptable methods of contraception for 6 months post surgery.
- Subjects must have read, understood and signed an institutional review board (IRB)-approved Informed Consent Form (ICF).
- Subjects must be able and willing to follow study procedures and instructions.
Key exclusion criteria (18 listed)
- Subject has extremely prominent root surfaces (> 1/2 the diameter of the root facial to cortical plate).
- Subject has interproximal attachment loss beyond the CEJ.
- Subject with teeth that have a Miller Grade 2 or higher mobility.
- Subjects with Class V restorations.
- Subjects with crowns on the teeth selected for treatment.
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 |
|---|---|---|
| CelTxSingle application; split-mouth design | Device | CelTx |
| Autologous sub-epithelial connective tissue graftSingle application; split-mouth design | Other | Autologous CTG |
Primary outcome
Overall Rate of Adverse Events (AEs)
Time frame: 6-month
Adverse events were collected at every visit throughout the 6 month duration. An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.
4 secondary outcomes
Periodontal Health Measures
Time frame: 6-months
Aesthetic Measures
Time frame: 6-months
Post-Surgical Subject Comfort Measures
Time frame: 4-weeks
Subject Preference Measures
Time frame: 6-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Gingival Recession
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
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.
Michael McGuire, DDS principal investigator
Perio Health Professionals, PLLC
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 CelTx and Autologous sub-epithelial connective tissue graft 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 5 inclusion and 18 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 11 Jan 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.
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?
Yes. Results are posted in the registry (first posted 21 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Rate of Adverse Events (AEs) (time frame: 6-month). 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 11 Jan 2012.