Gingival RecessionNCT03226600
OrACELL™ vs. Connective Tissue in Miller Class 3 Defects
A study testing OrACELL and Connective Tissue Graft in people with Gingival Recession, run by Texas A&M University.
Trial summary
The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- OrACELL and Connective Tissue Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2015to 16 Dec 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
- The defect must be at least 2mm in length, (measured from the CEJ to the midfacial gingival margin) and classified as either Miller Class I, II or III
- Study is limited to vital and nonvital incisors, canines, and premolars
- If teeth adjacent to the site to be treated had recession as well, they were included in the grafting procedure but not included in measurement
- Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
- Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery
Who cannot join
- Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
- History of previous history of surgery performed at surgical sites included in study
- Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
- Non-English speakers
- Pregnant or lactating females
- Immunosuppressant medications
About this study
Official title: A COMPARATIVE STUDY OF ROOT COVERAGE USING OrACELL™ VERSUS SUBEPITHELIAL CONNECTIVE TISSUE GRAFT: A RANDOMIZED CONTROLLED TRIAL
The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.
Read the detailed description
Twenty-four non-smoking, healthy patients, with 2mm or greater facial gingival recession at a minimum of one site that classified as a Miller Class I, II, or III recession defect were included. Patients were randomly assigned to either control (CTG) or OrACELL™ (test) groups, which were treated with identical surgical techniques. All root coverage clinical parameters were evaluated at baseline, 3-, and 6-months.
- Conditions
- Gingival Recession
- Being tested
- OrACELL, Connective Tissue Graft
- Keywords
- Gingival Recession, Connective Tissue Graft, OrACELL, Decellularized Dermis, Periodontics
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrACELLDevice
OrACELL is human dermis that undergoes the MATRACELL process. MATRACELL is a patented and validated process that renders allograft tissue acellular, without compromising the biomechanical or desired biochemical properties of an allograft bio-implant for its intended surgical application.
Connective Tissue GraftDevice
Also called Subepithelial Connective Tissue Graft
A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Graft | Active comparator | Connective Tissue is harvested from the palate of the subject then placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the connective tissue graft and the recession. Receives: Device: Connective Tissue Graft |
| OrACELL | Experimental | Allograft Tissue (human dermis) is removed from packing and placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the OrACELL graft and the recession. Receives: Device: OrACELL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Recession (Root Coverage)
The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin
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 posted24 Jul 2017
- Study start26 Mar 2015
- Primary completion13 Jun 2016
- Study completion16 Dec 2016
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
- Model description
- Randomized Controlled Trial between two treatment modalities for gingival recession with 6 month follow-up
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- LifeNet Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226600
- Sponsor's protocol ID
- 2014-0833-BCD-FB
- Status last verified
- May 2017
- First submitted
- 31 May 2017
- Last updated
- 24 Jul 2017
- 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 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A COMPARATIVE STUDY OF ROOT COVERAGE USING OrACELL™ VERSUS SUBEPITHELIAL CONNECTIVE TISSUE GRAFT: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT03226600
- Acronym / sponsor ID
- 2014-0833-BCD-FB
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession, Connective Tissue Graft, OrACELL, Decellularized Dermis, Periodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- LifeNet Health
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 13 Jun 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 24 Jul 2017 (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.
The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.
Detailed description
Twenty-four non-smoking, healthy patients, with 2mm or greater facial gingival recession at a minimum of one site that classified as a Miller Class I, II, or III recession defect were included. Patients were randomly assigned to either control (CTG) or OrACELL™ (test) groups, which were treated with identical surgical techniques. All root coverage clinical parameters were evaluated at baseline, 3-, and 6-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial between two treatment modalities for gingival recession with 6 month follow-up
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Graft | Active comparator | Device: Connective Tissue GraftConnective Tissue is harvested from the palate of the subject then placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the connective tissue graft and the recession. |
| OrACELL | Experimental | Device: OrACELLAllograft Tissue (human dermis) is removed from packing and placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the OrACELL graft and the recession. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
- The defect must be at least 2mm in length, (measured from the CEJ to the midfacial gingival margin) and classified as either Miller Class I, II or III
- Study is limited to vital and nonvital incisors, canines, and premolars
- If teeth adjacent to the site to be treated had recession as well, they were included in the grafting procedure but not included in measurement
- Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
Key exclusion criteria (6 listed)
- Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
- History of previous history of surgery performed at surgical sites included in study
- Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
- Non-English speakers
- Pregnant or lactating females
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 |
|---|---|---|
| OrACELLOrACELL is human dermis that undergoes the MATRACELL process. MATRACELL is a patented and validated process that renders allograft tissue acellular, without compromising the biomechanical or desired biochemical properties of an allograft bio-implant for its intended surgical application. | Device | OrACELL |
| Connective Tissue GraftAlso: Subepithelial Connective Tissue GraftA measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession | Device | Connective Tissue Graft |
Primary outcome
Gingival Recession (Root Coverage)
Time frame: 6 months
The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin
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 24 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Gingival Recession
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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
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing OrACELL and Connective Tissue Graft in people with Gingival Recession, run by Texas A&M University.
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 6 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 24 Jul 2017. 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?
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?
Gingival Recession (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 24 Jul 2017.