Root CoverageNCT01901822
Root Coverage Comparing Suturing Techniques
A study testing Sutured together and Sutured separately in people with Root Coverage, run by University of Louisville at 1 site in United States.
Trial summary
The hypothesis of this study is that coronally positioned tunnel with acellular dermal matrix using a continuous sling suture to secure both the graft and the flap will result in better percent root coverage compared to the continuous sling suturing technique to secure the graft and the flap separately. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Root Coverage
- What is being tested?
- Sutured together and Sutured separately
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2014
- 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).
- The mucogingival defect must be on a non-molar tooth.
- Patients must be between ≥ 18 years of age.
Who cannot join
- 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 cemento-enamel junction.
- Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
- Patients who are pregnant or lactating.
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- 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 guided tissue regeneration, 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 Clinic University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Suturing Techniques.
The hypothesis of this study is that coronally positioned tunnel with acellular dermal matrix using a continuous sling suture to secure both the graft and the flap will result in better percent root coverage compared to the continuous sling suturing technique to secure the graft and the flap separately.
Read the detailed description
Thirty patients will be selected by meeting the following criteria:
Inclusion Criteria:
- 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 between ≥ 18 years of age.
Exclusion Criteria:
- 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 cemento-enamel junction. F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
- 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 guided tissue regeneration, on the test teeth.
- Patients who fail to complete the informed consent form.
- Conditions
- Root Coverage
- Being tested
- Sutured together, Sutured separately
- Keywords
- acellular dermal matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sutured togetherProcedure or surgery
The soft tissue and the allograft will be sutured together using a continuous sling suture.
Sutured separatelyProcedure or surgery
The soft tissue and the allograft will be sutured separately using a continuous sling suture.
| Study group | Role | What they receive |
|---|---|---|
| Sutured separately | Active comparator | The soft tissue and the allograft will each be sutured separately using a continuous sling suture. Receives: Procedure: Sutured separately |
| Sutured together | Experimental | The soft tissue and the allograft will be sutured together using a continuous sling suture. Receives: Procedure: Sutured together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent root coverage
The amount of root coverage will be measured and converted to a percent.
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 posted17 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root CoverageStudies 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
- 16 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, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901822
- Sponsor's protocol ID
- 13.0332
- Status last verified
- Dec 2016
- First submitted
- 12 Jul 2013
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. 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 Suturing Techniques.
- ClinicalTrials.gov ID
- NCT01901822
- Acronym / sponsor ID
- 13.0332
- Conditions
- Root Coverage
- Keywords
- acellular dermal matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Jul 2013 (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.
The hypothesis of this study is that coronally positioned tunnel with acellular dermal matrix using a continuous sling suture to secure both the graft and the flap will result in better percent root coverage compared to the continuous sling suturing technique to secure the graft and the flap separately.
Detailed description
Thirty patients will be selected by meeting the following criteria:
Inclusion Criteria:
- 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 between ≥ 18 years of age.
Exclusion Criteria:
- 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 cemento-enamel junction. F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
- 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 guided tissue regeneration, on the test teeth.
- Patients who fail to complete the informed consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sutured separately | Active comparator | Procedure: Sutured separatelyThe soft tissue and the allograft will each be sutured separately using a continuous sling suture. |
| Sutured together | Experimental | Procedure: Sutured togetherThe soft tissue and the allograft will be sutured together using a continuous sling suture. |
Who may qualify
- Ages
- 18 years and older
- 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 between ≥ 18 years of age.
Key exclusion criteria (11 listed)
- 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 cemento-enamel junction.
- Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
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 |
|---|---|---|
| Sutured togetherThe soft tissue and the allograft will be sutured together using a continuous sling suture. | Procedure or surgery | Sutured together |
| Sutured separatelyThe soft tissue and the allograft will be sutured separately using a continuous sling suture. | Procedure or surgery | Sutured separately |
Primary outcome
Percent root coverage
Time frame: 6 months
The amount of root coverage will be measured and converted to a percent.
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 8 Dec 2016.
Related trials for Root Coverage
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
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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
Recruiting
Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
Gingival Recessions
Not yet recruiting
The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession.
Gingival Recession Defects
Active, not recruiting
V-CAF Technique for Miller Class III Gingival Recession
Gingival Recession, Gum 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, DMD 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 Sutured together and Sutured separately in people with Root Coverage, 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 11 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 8 Dec 2016. 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: 6 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 8 Dec 2016.