Gingival RecessionNCT02810067
Root Coverage Comparing an Allograft to a Bovine Xenograft
A study testing Tunnel + AlloDerm and Tunnel + Novomatrix in people with Gingival Recession, run by University of Louisville at 1 site in United States.
Trial summary
Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Tunnel + AlloDerm and Tunnel + Novomatrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2017
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
- The mucogingival defect must be on a non-molar tooth.
- Patients must be at least 18 years of age.
Who cannot join
- Patients with debilitating systemic or diseases that significantly affect the periodontium.
- Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
- Patients requiring antibiotic prophylaxis.
- Root surface restorations at the site of recession.
- No detectable CEJ
- Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
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- Patients who are pregnant or lactating.
- Patients who use tobacco products (smoking or smokeless tobacco).
- Patients with alcohol abuse problems.
- Patients undergoing long-term steroid therapy.
- History of previous root coverage procedures, graft or GTR, on the test teeth.
- Patients who fail to complete the informed consent form.
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Periodontics, UofL School of Dentistry
Louisville, Kentucky, 40202
About this study
Official title: Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Donor Materials
Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials
Read the detailed description
Thirty patients will be treated: 15 with a coronally positioned tunnel technique with NovaDerm® xenograft using continuous sling suture to secure both the graft and the flap (test treatment) and 15 with a coronally positioned tunnel technique with AlloDerm® allograft using continuous sling suture to secure both the graft and the flap (control treatment). Sutures used for the control group will be Maxon 5-0, 3/8 circle 13 mm needle for both the test and control groups. The coronally positioned tunnel technique was previously described by Edwards Pat Allen (E.P. Allen, Center for Advanced Dental Education, Dallas, Texas; course manual). Each patient will provide at least one Miller Class I or II facial recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive either the test or control treatment. Mentor will toss the coin immediately prior to suturing. Patients will be evaluated postoperatively for a period of 4 months. The examiner will be blinded and will not be aware of the patient treatment at any time during the term of the study. Three exams for measurements will be performed per patient on total: preoperative, at week eight and 16 (4 months) postoperatively.
- Conditions
- Gingival Recession
- Being tested
- Tunnel + AlloDerm, Tunnel + Novomatrix
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunnel + AlloDermProcedure or surgery
Also called AlloDerm®
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm).
Tunnel + NovomatrixProcedure or surgery
Also called Novomatrix
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).
| Study group | Role | What they receive |
|---|---|---|
| Tunnel + AlloDerm® | Active comparator | A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®). Receives: Procedure: Tunnel + AlloDerm |
| Tunnel + Novomatrix | Experimental | A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix). Receives: Procedure: Tunnel + Novomatrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent root coverage
Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Study was dropped and never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Greenwell, University of Louisville
- Investigators
- Henry Greenwell, DMD, MS, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810067
- Sponsor's protocol ID
- 17.0534
- Status last verified
- Jun 2018
- First submitted
- 20 Jun 2016
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Donor Materials
- ClinicalTrials.gov ID
- NCT02810067
- Acronym / sponsor ID
- 17.0534
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was dropped and never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jun 2016 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Jun 2016 (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.
Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials
Detailed description
Thirty patients will be treated: 15 with a coronally positioned tunnel technique with NovaDerm® xenograft using continuous sling suture to secure both the graft and the flap (test treatment) and 15 with a coronally positioned tunnel technique with AlloDerm® allograft using continuous sling suture to secure both the graft and the flap (control treatment). Sutures used for the control group will be Maxon 5-0, 3/8 circle 13 mm needle for both the test and control groups. The coronally positioned tunnel technique was previously described by Edwards Pat Allen (E.P. Allen, Center for Advanced Dental Education, Dallas, Texas; course manual). Each patient will provide at least one Miller Class I or II facial recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive either the test or control treatment. Mentor will toss the coin immediately prior to suturing. Patients will be evaluated postoperatively for a period of 4 months. The examiner will be blinded and will not be aware of the patient treatment at any time during the term of the study. Three exams for measurements will be performed per patient on total: preoperative, at week eight and 16 (4 months) postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tunnel + AlloDerm® | Active comparator | Procedure: Tunnel + AlloDermA coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®). |
| Tunnel + Novomatrix | Experimental | Procedure: Tunnel + NovomatrixA coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
- The mucogingival defect must be on a non-molar tooth.
- Patients must be at least 18 years of age.
Key exclusion criteria (12 listed)
- Patients with debilitating systemic or diseases that significantly affect the periodontium.
- Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
- Patients requiring antibiotic prophylaxis.
- Root surface restorations at the site of recession.
- No detectable CEJ
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 |
|---|---|---|
| Tunnel + AlloDermAlso: AlloDerm®A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm). | Procedure or surgery | Tunnel + AlloDerm® |
| Tunnel + NovomatrixAlso: NovomatrixA coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix). | Procedure or surgery | Tunnel + Novomatrix |
Primary outcome
Percent root coverage
Time frame: 4 months
Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- 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.
Henry Greenwell, DMD, MS principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunnel + AlloDerm and Tunnel + Novomatrix in people with Gingival Recession, run by University of Louisville 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 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: withdrawn, as of the sponsor's last update on 18 Jun 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent root coverage (time frame: 4 months). 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 18 Jun 2018.