Gingival RecessionNCT01134081
Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
A study testing CelTx™ and Free Gingival Graft in people with Gingival Recession, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this observational research study is to understand more about wound healing of gum tissue. This study was the biomarker study of a small cohort of study participants derived from NCT01547962 (completed). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- CelTx™ and Free Gingival Graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2008
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has signed informed consent to participate in Organogenesis Clinical Protocol 06-PER-002-CTX.
- Subject has signed informed consent to participate in this adjunct bio-marker study.
- Subject is willing to comply with the additional study visits at weeks 2 and 3 as required by this study.
Who cannot join
- Subject requires antibiotic prophylaxis for routine dental procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
The purpose of this observational research study is to understand more about wound healing of gum tissue. This study was the biomarker study of a small cohort of study participants derived from NCT01547962 (completed). Two surgical sites of each patient were randomly selected to receive CelTx™ as a donor material in one site and conventional autograft using keratinized tissue from the palate as the donor material at the contralateral (opposite side) site. Fluids collected from between a tooth and the gum and directly from wounds contain proteins that occur in different levels as the wound healing process proceeds. In this research study wound fluid will be collected from the donor palate site (roof of your mouth) and the treated sites on your gum before and after placement of CelTx and conventional treatment (tissue from the roof of your mouth) to measure which proteins and how much of each are present during the first 4 weeks of wound healing.
Read the detailed description
In a clinical trial designed to evaluate the safety and effectiveness of rhPDGF-BB to promote soft and hard tissue engineering of the periodontium, the subjects provided gingival crevicular fluid (GCF) or periodontal wound fluid (WF) and the results demonstrated contrasting inducible expression patterns of PDGF-AB, VEGF, and ICTP during periodontal healing [17, 24, 25]. However, little is known regarding the release of these molecules into local periodontal wound fluid during tissue-engineered grafts.
The aim of this study is to determine the presence and influence of angiogenic biomarkers, such as PDGF, VEGF, and FGF, involved in the wound healing process of tissue engineered grafts in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingival associated with at least two nonadjacent teeth.
STUDY OBJECTIVES The purpose of this pilot study is to compare the expression of angiogenic biomarkers involved in the wound healing process of 2 different periodontal surgical approaches: 1) CelTx™ (living bilayered cell therapy product) and 2) free gingival grafts
- Conditions
- Gingival Recession
- Being tested
- CelTx™, Free Gingival Graft
- Keywords
- gum, recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelTx™Biological
CelTx™ is a living bilayered cell therapy product. CelTx™ is constructed of Type I bovine collagen (extracted from bovine tendons and subsequently purified) and viable allogeneic human fibroblasts and keratinocytes isolated from human neonatal foreskin. This is applied once in the oral cavity.
Free Gingival GraftProcedure or surgery
Harvested tissue from palate
| Study group | Role | What they receive |
|---|---|---|
| CelTx™ | Experimental | Living bilayered cell therapy product Receives: Biological: CelTx™ |
| Free Gingival Grafts | Active comparator | Harvested tissue from palate Receives: Procedure: Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Angiogenic Biomarkers
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
Measured: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Differences in Angiogenic Biomarkers: PDGF-BB
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
Measured: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Organogenesis
- Responsible party
- Principal investigator, William Giannobile, University of Michigan
- Investigators
- Rodrigo Neiva, DDS, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134081
- Sponsor's protocol ID
- 06-PER-002-CTX Bio Adjunct
- Status last verified
- Jun 2017
- First submitted
- 20 May 2010
- Last updated
- 21 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Morelli T, Neiva R, Nevins ML, McGuire MK, Scheyer ET, Oh TJ, Braun TM, Nor JE, Bates D, Giannobile WV. Angiogenic biomarkers and healing of living cellular constructs. J Dent Res. 2011 Apr;90(4):456-62. doi: 10.1177/0022034510389334. Epub 2011 Jan 19.
PubMed 21248359
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
- ClinicalTrials.gov ID
- NCT01134081
- Acronym / sponsor ID
- 06-PER-002-CTX Bio Adjunct
- Conditions
- Gingival Recession
- Keywords
- gum, recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Organogenesis
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Posted 18 Jul 2017
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 observational research study is to understand more about wound healing of gum tissue. This study was the biomarker study of a small cohort of study participants derived from NCT01547962 (completed). Two surgical sites of each patient were randomly selected to receive CelTx™ as a donor material in one site and conventional autograft using keratinized tissue from the palate as the donor material at the contralateral (opposite side) site. Fluids collected from between a tooth and the gum and directly from wounds contain proteins that occur in different levels as the wound healing process proceeds. In this research study wound fluid will be collected from the donor palate site (roof of your mouth) and the treated sites on your gum before and after placement of CelTx and conventional treatment (tissue from the roof of your mouth) to measure which proteins and how much of each are present during the first 4 weeks of wound healing.
Detailed description
In a clinical trial designed to evaluate the safety and effectiveness of rhPDGF-BB to promote soft and hard tissue engineering of the periodontium, the subjects provided gingival crevicular fluid (GCF) or periodontal wound fluid (WF) and the results demonstrated contrasting inducible expression patterns of PDGF-AB, VEGF, and ICTP during periodontal healing [17, 24, 25]. However, little is known regarding the release of these molecules into local periodontal wound fluid during tissue-engineered grafts.
The aim of this study is to determine the presence and influence of angiogenic biomarkers, such as PDGF, VEGF, and FGF, involved in the wound healing process of tissue engineered grafts in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingival associated with at least two nonadjacent teeth.
STUDY OBJECTIVES The purpose of this pilot study is to compare the expression of angiogenic biomarkers involved in the wound healing process of 2 different periodontal surgical approaches: 1) CelTx™ (living bilayered cell therapy product) and 2) free gingival grafts
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CelTx™ | Experimental | Biological: CelTx™Living bilayered cell therapy product |
| Free Gingival Grafts | Active comparator | Procedure: Free Gingival GraftHarvested tissue from palate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has signed informed consent to participate in Organogenesis Clinical Protocol 06-PER-002-CTX.
- Subject has signed informed consent to participate in this adjunct bio-marker study.
- Subject is willing to comply with the additional study visits at weeks 2 and 3 as required by this study.
Key exclusion criteria (1 listed)
- Subject requires antibiotic prophylaxis for routine dental procedures.
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 |
|---|---|---|
| CelTx™CelTx™ is a living bilayered cell therapy product. CelTx™ is constructed of Type I bovine collagen (extracted from bovine tendons and subsequently purified) and viable allogeneic human fibroblasts and keratinocytes isolated from human neonatal foreskin. This is applied once in the oral cavity. | Biological | CelTx™ |
| Free Gingival GraftHarvested tissue from palate | Procedure or surgery | Free Gingival Grafts |
Primary outcome
Differences in Angiogenic Biomarkers
Time frame: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
Differences in Angiogenic Biomarkers: PDGF-BB
Time frame: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21248359Morelli T, Neiva R, Nevins ML, McGuire MK, Scheyer ET, Oh TJ, Braun TM, Nor JE, Bates D, Giannobile WV. Angiogenic biomarkers and healing of living cellular constructs. J Dent Res. 2011 Apr;90(4):456-62. doi: 10.1177/0022034510389334. Epub 2011 Jan 19.
- Individual participant dataSharing planned: No
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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.
Rodrigo Neiva, DDS, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CelTx™ and Free Gingival Graft in people with Gingival Recession, run by University of Michigan 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 3 inclusion and 1 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 21 Aug 2017. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2017). 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?
Differences in Angiogenic Biomarkers (time frame: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4). The study lists 2 primary outcomes in all. 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 NCT01134081, 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 21 Aug 2017.