Gingival RecessionADMNCT03392038
Thick vs. Thin Acellular Dermal Matrix (ADM)
A study testing Thin ADM and Thick ADM in people with Gingival Recession, run by University of Louisville at 1 site in United States.
Trial summary
To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Thin ADM and Thick ADM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 21 Aug 2018
- 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 years and older
- 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). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be ≥ 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. D. Root surface restorations at the site of recession. E. No detectable CEJ F. Patients who fail to maintain acceptable oral hygiene levels at the test and adjacent teeth.
- Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. 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 Using the Coronally Positioned Tunnel Technique Comparing Thick Versus Thin Acellular Dermal Matrix
To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique.
- Conditions
- Gingival Recession
- Being tested
- Thin ADM, Thick ADM
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thin ADMProcedure or surgery
Also called Thin acellular dermal matrix (ADM GBR)
Use of soft tissue allograft for root coverage
Thick ADMProcedure or surgery
Also called Thick acellular dermal matrix graft (ADM)
Periodontal surgical procedure to coronally position the tissue over the ADM allograft
| Study group | Role | What they receive |
|---|---|---|
| Thin ADM | Experimental | Periodontal root coverage surgery using a coronally positioned tunnel and thin acellular dermal matrix (ADM GBR) Receives: Procedure: Thin ADM |
| Thick ADM | Active comparator | Periodontal root coverage surgery using coronally positioned tunnel surgery and thick acellular dermal matrix graft (ADM) Receives: Procedure: Thick ADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent root coverage
Between 0 and 100%
Measured: Six months
Secondary outcomes (1)
Creeping Attachment
Amount in millimeters
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start30 Nov 2017
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
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.
- 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
- 22 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, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392038
- Sponsor's protocol ID
- 16.0462
- Acronym
- ADM
- Status last verified
- Sep 2020
- First submitted
- 31 Dec 2017
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Coverage Using the Coronally Positioned Tunnel Technique Comparing Thick Versus Thin Acellular Dermal Matrix
- ClinicalTrials.gov ID
- NCT03392038
- Acronym / sponsor ID
- ADM / 16.0462
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 5 Jan 2018 (actual)
- 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.
To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thin ADM | Experimental | Procedure: Thin ADMPeriodontal root coverage surgery using a coronally positioned tunnel and thin acellular dermal matrix (ADM GBR) |
| Thick ADM | Active comparator | Procedure: Thick ADMPeriodontal root coverage surgery using coronally positioned tunnel surgery and thick acellular dermal matrix graft (ADM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be ≥ 18 years of age.
Key exclusion criteria (5 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. D. Root surface restorations at the site of recession. E. No detectable CEJ F. Patients who fail to maintain acceptable oral hygiene levels at the test and adjacent teeth.
- Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. History of previous root coverage procedures, graft or GTR, on the test teeth.
- Patients who fail to complete the informed consent form.
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 |
|---|---|---|
| Thin ADMAlso: Thin acellular dermal matrix (ADM GBR)Use of soft tissue allograft for root coverage | Procedure or surgery | Thin ADM |
| Thick ADMAlso: Thick acellular dermal matrix graft (ADM)Periodontal surgical procedure to coronally position the tissue over the ADM allograft | Procedure or surgery | Thick ADM |
Primary outcome
Percent root coverage
Time frame: Six months
Between 0 and 100%
1 secondary outcome
Creeping Attachment
Time frame: Six 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 10 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Gingival Recession
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
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Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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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
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Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
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Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
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.
Henry Greenwell 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 Thin ADM and Thick ADM 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 1 inclusion and 5 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 10 Sep 2020. 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?
Percent root coverage (time frame: Six 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 10 Sep 2020.