Gingival DiseasesNCT01952301
Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation
A study testing Xenogeneic Collagen Matrix and Free Gingival Graft in people with Gingival Diseases, run by Perio Health Professionals, PLLC.
Trial summary
A split-mouth study comparing soft tissue augmentation results using free gingival graft (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT) around teeth with insufficient (< 2mm) KT. Read more about this study
- Who is it for?
- Ages 8 to 70 years
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- Xenogeneic Collagen Matrix and Free Gingival Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Jan 2012
- 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 8 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least two non-adjacent teeth in contralateral quadrants of the same jaw with < 2mm of KT that requires soft tissue grafting (1-4 teeth may be treated). In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment). The number of teeth treated must be the same on the test and control sites.
- Root coverage is not desired at the time of grafting.
- Females of childbearing potential must have a documented negative urine pregnancy test.
- Read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- Able and willing to follow study procedures and instructions.
- Multi-rooted teeth may be treated but will not be included as study teeth
Who cannot join
- Vestibule depth of less than 7mm from base of recession, and/or teeth with Miller Grade 2 or higher mobility.
- Any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude periodontal surgery; or 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.
- Presence of acute infectious lesions in the areas intended for surgery.
- History of any tobacco use within the last six months.
- Taking intramuscular or intravenous bisphosphonates.
- Known hypersensitivity to collagen products, and/or allergy to iodine or shellfish.
Show all 10Show fewer
- Participating in other clinical studies involving therapeutic intervention (either medical or dental).
- Previously undergone a gingival grafting procedure on the test or control teeth or the teeth adjacent to the study site.
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration following entrance into the study.
- 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.
About this study
Official title: A Randomized, Controlled Clinical Trial to Evaluate a Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation
A split-mouth study comparing soft tissue augmentation results using free gingival graft (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT) around teeth with insufficient (< 2mm) KT.
Read the detailed description
A single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (< 2mm). The study utilized a within subject treatment comparison design to establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy endpoint was KT width at 6-months. Secondary endpoints included traditional periodontal measures, such as clinical attachment, recession and bleeding on probing. Patient reported pain, discomfort and esthetic satisfaction were also recorded. Biopsies were obtained at 6-months.
- Conditions
- Gingival Diseases
- Being tested
- Xenogeneic Collagen Matrix, Free Gingival Graft
- Keywords
- Autologous; Collagen Matrix; Keratinized Tissue
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenogeneic Collagen MatrixDevice
A type I and III porcine collagen matrix, as cleared by FDA (K012423)
Free Gingival GraftDevice
Also called Free Autogenous Graft
Autogenous, full-thickness soft tissue graft harvested from patient's palate.
| Study group | Role | What they receive |
|---|---|---|
| xenogeneic collagen matrix | Active comparator | Xenogeneic collagen matrix device placed on treatment wound bed site Receives: Device: Xenogeneic Collagen Matrix |
| Free Gingival Graft | Active comparator | Traditional free gingival graft (autogenous graft device harvested from patient's palate) placed on treatment site wound bed Receives: Device: Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized Tissue Width
Change in Keratinized Tissue width
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 posted27 Sep 2013 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionJan 2012
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 DiseasesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perio Health Professionals, PLLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael K McGuire, Perio Health Professionals, PLLC
- Investigators
- Michael K McGuire, DDS, Principal investigator, Perio Health Professionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952301
- Sponsor's protocol ID
- 13562-007
- Status last verified
- May 2014
- First submitted
- 24 Sep 2013
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.
PubMed 24597764
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial to Evaluate a Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation
- ClinicalTrials.gov ID
- NCT01952301
- Acronym / sponsor ID
- 13562-007
- Conditions
- Gingival Diseases
- Keywords
- Autologous; Collagen Matrix; Keratinized Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Perio Health Professionals, PLLCUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Posted 15 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A split-mouth study comparing soft tissue augmentation results using free gingival graft (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT) around teeth with insufficient (< 2mm) KT.
Detailed description
A single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (< 2mm). The study utilized a within subject treatment comparison design to establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy endpoint was KT width at 6-months. Secondary endpoints included traditional periodontal measures, such as clinical attachment, recession and bleeding on probing. Patient reported pain, discomfort and esthetic satisfaction were also recorded. Biopsies were obtained at 6-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| xenogeneic collagen matrix | Active comparator | Device: Xenogeneic Collagen MatrixXenogeneic collagen matrix device placed on treatment wound bed site |
| Free Gingival Graft | Active comparator | Device: Free Gingival GraftTraditional free gingival graft (autogenous graft device harvested from patient's palate) placed on treatment site wound bed |
Who may qualify
- Ages
- 8 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- At least two non-adjacent teeth in contralateral quadrants of the same jaw with < 2mm of KT that requires soft tissue grafting (1-4 teeth may be treated). In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment). The number of teeth treated must be the same on the test and control sites.
Key exclusion criteria (10 listed)
- Vestibule depth of less than 7mm from base of recession, and/or teeth with Miller Grade 2 or higher mobility.
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 |
|---|---|---|
| Xenogeneic Collagen MatrixA type I and III porcine collagen matrix, as cleared by FDA (K012423) | Device | xenogeneic collagen matrix |
| Free Gingival GraftAlso: Free Autogenous GraftAutogenous, full-thickness soft tissue graft harvested from patient's palate. | Device | Free Gingival Graft |
Primary outcome
Keratinized Tissue Width
Time frame: 6 months
Change in Keratinized Tissue width
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24597764McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.
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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.
Michael K McGuire, DDS principal investigator
Perio Health Professionals
Questions about this trial
What is this clinical trial studying?
A study testing Xenogeneic Collagen Matrix and Free Gingival Graft in people with Gingival Diseases, run by Perio Health Professionals, PLLC.
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 10 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 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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 15 May 2014). 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?
Keratinized Tissue Width (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 NCT01952301, 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 Jun 2014.