Gingival RecessionVISTANCT03566108
To Compare Two Commonly Used Soft Tissue Grafting Techniques to Achieve Coronal Flap Advancement and Root Coverage
A study testing VISTA and STA in people with Gingival Recession, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- VISTA and STA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 30 Aug 2022
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- At least 18 years old
- Must be a patient of the UAB Dental School
- Able to read and understand informed consent document
- One or more adjacent teeth (up to four) with Miller class I or II gingival recession defects and less than or equal to 2mm of KT at each site to be treated.
- Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)
- No anticipated need for restorative care at the teeth to be treated during the study period.
Who cannot join
- Non-English speaking
- Less than 18 years old
- Smokers/tobacco users (>10 cigarettes/day)
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Presence of active periodontal disease or radiographic interproximal bone loss or tooth malposition, which would yield a Miller class III or IV categorization for the recession defect.
- Presence of frenulae or other soft tissue anomalies at the site(s) to be treated that, in the opinion of the investigators, will interfere with successful access and treatment of the soft tissue defects.
- Previous soft tissue grafting at the site(s) to be treated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0007
About this study
Official title: A Prospective, Randomized Clinical Trial to Compare Vestibular Incision Supraperiosteal Tunnel Access (VISTA) and Sulcular Tunnel Access Procedures With Coronally Advanced Flap (CAF) and Acellular Dermal Matrix (ADM).
This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva.
To the investigators knowledge, these two techniques have not been compared for differences in clinical (amount of root coverage, tissue thickness, and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
Read the detailed description
Research data and daily clinical observations reveal that teeth with gingival recession and a lack of adequate keratinized tissue (KT) are more prone to persistent gingival inflammation, dentinal sensitivity, radicular (root) caries (tooth decay), faster periodontal attachment loss, and compromised plaque control. Soft tissue grating (by various techniques) aims at changing the quality, quantity and placement of the soft tissue around teeth by covering exposed root surfaces and creating or increasing the zone of keratinized mucosa (KM) surrounding the affected teeth. Both techniques tested have shown good clinical outcomes with regard to root coverage, but clinical reports of the VISTA technique and other similar techniques suggest that patients experience a decrease in site morbidity and discomfort post-operatively. This study will compare two surgical incision designs used in conjunction with coronally advanced flap (CAF) and acellular dermal matrix (ADM)
Specific aims for this project include the evaluation of:
- Percentage of root coverage at 6 and 12 months following grafting with VISTA and sulcular tunnel access with ADM
- KT width at 6 and 12 month following grafting with VISTA and sulcular tunnel access with ADM
- Change in tissue thickness of the grafted sites at 6 and 12 months
- Practitioner-assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively
- Patient-assessed esthetic outcomes at 6 and 12 months post-operatively
- Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively
- Conditions
- Gingival Recession
- Being tested
- VISTA, STA
- Keywords
- Gingival phenotype, Keratinized gingiva, Gingival recession, Soft tissue recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISTAProcedure or surgery
Vestibular incision supraperiosteal tunnel access (VISTA) incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
STAProcedure or surgery
Sulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
| Study group | Role | What they receive |
|---|---|---|
| VISTA | Experimental | VISTA incision with CAF and ADM Receives: Procedure: VISTA |
| Sulcular Tunnell access | Active comparator | Sulcular tunnel surgery with CAF and ADM Receives: Procedure: STA |
What is being measured
The primary outcome is the main question the study is designed to answer.
KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM
Compare the increase in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.
Measured: From baseline to 6 months
Secondary outcomes (3)
Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between VISTA and STA following soft tissue grafting.
Measured: From baseline to 6 months
Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between VISTA and STA following soft tissue grafting.
Measured: From baseline to 6 months
Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively
Assess esthetic outcomes using an established Periodontal Esthetic Score (PES). This score evaluates the color of the gum utilizing 5 subscales ranging from 0 (worse) to 2 (better) allowing for a summed total score of 10.
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 posted21 Jun 2018
- Study start23 Apr 2019
- Primary completion29 Jan 2020
- Study completion30 Aug 2022
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.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham
- Investigators
- Maria L Geisinger, DDS, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566108
- Sponsor's protocol ID
- IRB-300001591
- Other IDs
- UAB Periodontology
- Acronym
- VISTA
- Status last verified
- Sep 2024
- First submitted
- 14 May 2018
- Last updated
- 18 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from this study will not be shared with other researchers outside of our research laboratory group.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Trial to Compare Vestibular Incision Supraperiosteal Tunnel Access (VISTA) and Sulcular Tunnel Access Procedures With Coronally Advanced Flap (CAF) and Acellular Dermal Matrix (ADM).
- ClinicalTrials.gov ID
- NCT03566108
- Acronym / sponsor ID
- VISTA / IRB-300001591
- Conditions
- Gingival Recession
- Keywords
- Gingival phenotype, Keratinized gingiva, Gingival recession, Soft tissue recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Posted 18 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva.
To the investigators knowledge, these two techniques have not been compared for differences in clinical (amount of root coverage, tissue thickness, and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
Detailed description
Research data and daily clinical observations reveal that teeth with gingival recession and a lack of adequate keratinized tissue (KT) are more prone to persistent gingival inflammation, dentinal sensitivity, radicular (root) caries (tooth decay), faster periodontal attachment loss, and compromised plaque control. Soft tissue grating (by various techniques) aims at changing the quality, quantity and placement of the soft tissue around teeth by covering exposed root surfaces and creating or increasing the zone of keratinized mucosa (KM) surrounding the affected teeth. Both techniques tested have shown good clinical outcomes with regard to root coverage, but clinical reports of the VISTA technique and other similar techniques suggest that patients experience a decrease in site morbidity and discomfort post-operatively. This study will compare two surgical incision designs used in conjunction with coronally advanced flap (CAF) and acellular dermal matrix (ADM)
Specific aims for this project include the evaluation of:
- Percentage of root coverage at 6 and 12 months following grafting with VISTA and sulcular tunnel access with ADM
- KT width at 6 and 12 month following grafting with VISTA and sulcular tunnel access with ADM
- Change in tissue thickness of the grafted sites at 6 and 12 months
- Practitioner-assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively
- Patient-assessed esthetic outcomes at 6 and 12 months post-operatively
- Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISTA | Experimental | Procedure: VISTAVISTA incision with CAF and ADM |
| Sulcular Tunnell access | Active comparator | Procedure: STASulcular tunnel surgery with CAF and ADM |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking
- At least 18 years old
- Must be a patient of the UAB Dental School
- Able to read and understand informed consent document
- One or more adjacent teeth (up to four) with Miller class I or II gingival recession defects and less than or equal to 2mm of KT at each site to be treated.
Key exclusion criteria (7 listed)
- Non-English speaking
- Less than 18 years old
- Smokers/tobacco users (>10 cigarettes/day)
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Presence of active periodontal disease or radiographic interproximal bone loss or tooth malposition, which would yield a Miller class III or IV categorization for the recession defect.
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 |
|---|---|---|
| VISTAVestibular incision supraperiosteal tunnel access (VISTA) incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix | Procedure or surgery | VISTA |
| STASulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix | Procedure or surgery | Sulcular Tunnell access |
Primary outcome
KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM
Time frame: From baseline to 6 months
Compare the increase in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.
3 secondary outcomes
Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM
Time frame: From baseline to 6 months
Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM
Time frame: From baseline to 6 months
Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data from this study will not be shared with other researchers outside of our research laboratory group.
Related trials for Gingival Recession
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
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
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Recruiting
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.
Maria L Geisinger, DDS, MS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VISTA and STA in people with Gingival Recession, run by University of Alabama at Birmingham 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 7 inclusion and 7 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 18 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2024). 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?
KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM (time frame: From baseline to 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 18 Nov 2024.