Gingival RecessionNCT03124329
Efficacy of Methods to Treat Multiple Gingival Recession Defects
A study testing Coronally Advanced Flap, Intrasulcular Tunneling and Vestibular Incision Subperiosteal Tunnel Access (VISTA) in people with Gingival Recession, run by University of Southern California at 1 site in United States.
Trial summary
Rationale: Treatment of gingival recession defects requires coronal advancement of the gingival margin due to patient esthetic demand, tooth sensitivity and improvement of tooth prognosis, which can be accomplished either through a flap procedure or through a tunnel. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Coronally Advanced Flap, Intrasulcular Tunneling and Vestibular Incision Subperiosteal Tunnel Access (VISTA)
- Type of treatment
- Medical device, 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
- 1 May 2017to 19 Jun 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female individuals between ages of 18 to 70 years old
- Multiple contiguous gingival recession defects on a minimum of two adjacent teeth, exhibiting 3mm or more recession on at least one of those teeth
- No prior surgical treatment in the sites planned for therapy
- Minimum of 2 mm of keratinized gingiva
- Absence of cervical restorations extending to the CEJ
- Miller class 1, 2 and 3 recession defects will be included
- Availability to undergo treatment and return for follow up visits at specified post-operative intervals
Who cannot join
- Molar teeth
- Milller Class 4 recession defects
- Pregnancy (Self-reported)
- Smoking
- Uncontrolled local or systemic diseases that affects wound healing (diabetes, autoimmune or inflammatory disorders)
- Past history of systemic steroid use over 2 weeks within the last 2 years
Show all 11Show fewer
- Poor oral hygiene on a non-compliant individual
- Ibuprofen Allergy/interlerance
- Anticoagulant therapy (e.g. Warfarin, Plavix, etc.), will not be automatic exclusion but patients will be required to have INR test performed and have values between 2.0 to 3. Physician consultation will be requested to determine whether anticoagulant therapy can be discontinued for 3 days prior to surgery.
- Objection to blood draw or application of blood products
- Students and staff from USC Ostrow school of Dentistry will not be recruited for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: An Open Prospective Randomized Controlled Clinical Trial to Examine the Efficacy of Methods to Treat Multiple Gingival Recession Defects
Rationale: Treatment of gingival recession defects requires coronal advancement of the gingival margin due to patient esthetic demand, tooth sensitivity and improvement of tooth prognosis, which can be accomplished either through a flap procedure or through a tunnel. It will be desirable to determine the efficacy of Vestibular Incision Subperiosteal Tunnel Access (VISTA) to Coronally Advanced Flap (CAF) procedure and intrasulcular tunneling.
Another aspect of the study is to determine whether autologous concentrate of platelets and leukocytes (leukocyte-platelet-rich fibrin; L-PRF) has equivalent efficacy to connective tissue autologous graft harvested from the palate.
Read more
The overall objective of this study is to evaluate the effectiveness of therapeutic modalities for the treatment of multiple gingival recession defects.
The study is designed as a prospective, randomized controlled clinical trial. Four groups will be compared:
Group 1: Coronally Advanced Flap (CAF) Group 2: VISTA Group 3: Intrasulcular tunneling (IST) Group 4: VISTA + L-PRF
Each of the groups will be treated without any graft material in order to examine the efficacy of coronal advancement and periodontal root coverage without the confounding variable of graft material. These techniques don't require any additional graft if there is adequate amount of keratinized gingiva
The study population will be patients who present to Advanced Graduate Program in Periodontology at the University of Southern California, USA, and are deemed to require treatment of multiple gingival recession defects. A total sample of 100 participants (23 participants per group) will provide a two sided test of means with 80% power at alpha of 0.05. The calculation was carried out using PASS Version 12 (Hintze, J. (2014). NCSS, LLC. Kaysville, Utah.)
The study duration will be 1 year. Follow-up visits after the surgery will occur after 3 days , 7 days and at weeks 3, 6, 12, 24, 36 and 52. These follow up visits consistent with standard of care follow up for gingival recession treatment and there will be no additional costs to the participant.
The Primary Outcome variable is complete root coverage; the Secondary Outcome Variables are clinical attachment level (CAL) gain, changes in gingival thickness and volume and the Tertiary Outcomes are aesthetic outcomes, postoperative pain and Patient satisfaction survey
- Conditions
- Gingival Recession
- Being tested
- Coronally Advanced Flap, Intrasulcular Tunneling, Vestibular Incision Subperiosteal Tunnel Access (VISTA), Leukocyte-Platelet Rich Fibrin (L-PRF)
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally Advanced FlapProcedure or surgery
Coronally advanced flap will be performed. Briefly, sulcular incisions will be made. Oblique incisions will be made on each papilla requiring root coverage. In the region coronal to the mucogingival junction (MGJ), mucoperiosteal flap will be elevated. Apical to the MGJ, sharp dissection will be performed to the periosteum allowing split-thickness flap elevation to be performed. Epithelium is removed from the papillae adjacent to the recession and the flap is coronally positioned and stabilized with interproximal sutures and apico-coronal interrupted sutures to close the vertical releasing incisions.
Intrasulcular TunnelingProcedure or surgery
Initial sulcular incisions are made and small, contoured blades and mini curettes are used to create the recipient pouches and tunnels. The tunnel will be subperiosteal in location. The incision is extended to one adjacent tooth both mesially and distally. This incision maintains the full height and thickness of the gingival component and enables access beneath the buccal gingiva. The connective tissue beyond the mucogingival line will be dissected and free the buccal flap from its insertions to the bone around each tooth. Muscle fibers and any remaining collagen fibers on the inner aspect of the flap, which prevent the buccal gingiva from being moved coronally, are cut. The papillae are kept intact and undermined to maintain their integrity and carefully released from the underlying bone, which allows the coronal positioning of the papillae. An envelope, full-thickness pouch, and tunnel are created and extended apically beyond the mucogingival line by blunt dissection
Vestibular Incision Subperiosteal Tunnel Access (VISTA)Biological
The VISTA approach begins with a Vestibular Incision Subperiosteal Tunnel Access. Through this incision a subperiosteal tunnel is created, exposing the facial osseous plate and root dehiscence. This tunnel will be extended at least one or two teeth beyond the teeth requiring root coverage to mobilize gingival margins and facilitate coronal repositioning. Additionally, the subperiosteal tunnel is extended interproximally under each papilla as far as the embrasure space permits, without making any surface incisions through the papilla. The mucogingival complex is then advanced coronally and stabilized in the new position with the coronally anchored suturing technique, which entails placing a horizontal mattress suture apical to the gingival margin of each tooth. The suture is tied to position the knot at the midcoronal point of the facial aspect of each tooth, which is secured with help of composite resin to prevent apical relapse of the gingival margin during initial stages of healing.
Leukocyte-Platelet Rich Fibrin (L-PRF)Device
Immediately prior to surgery, 72 mL of blood should be drawn from each patient by venipuncture of the antecubital vein and collected in a sterile glass test tube without any anticoagulant. Tubes should be centrifuged at 2,700 rpm for 12 minutes within 2 minutes after blood draw. For individuals on anti-coagulant therapy or supplements to interfere with coagulation, centrifugation will be for 18 minute. After centrifugation, each L-PRF clot will be separated from the portion of red blood cells (red thrombus), obtaining a fibrin clot with a red small portion in order to include the "buffy" coat richer in leucocytes. The L-PRF clot is condensed and modeled on a sterile surgical plate. L-PRF will be used within 60 minutes after the preparation.
| Study group | Role | What they receive |
|---|---|---|
| Coronally Advanced Flap | Experimental | Not described Receives: Procedure: Coronally Advanced Flap |
| Vestibular Incision Subperiosteal Tunnel Access (VISTA) | Experimental | Not described Receives: Biological: Vestibular Incision Subperiosteal Tunnel Access (VISTA) |
| Intrasulcular tunneling | Experimental | Not described Receives: Procedure: Intrasulcular Tunneling |
| VISTA + Leukocyte-Platelet Rich Fibrin | Experimental | Not described Receives: Biological: Vestibular Incision Subperiosteal Tunnel Access (VISTA); Device: Leukocyte-Platelet Rich Fibrin (L-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete root coverage
Complete coverage of the recession defect following surgery. It will be a binary outcome (Yes or No)
Measured: 12 months
Secondary outcomes (4)
Clinical Attachment Level gain
Gain of clinical attachment defined by the distance between the cement-enamel junction to the depth of the periodontal pocket around the teeth measured in mm by a periodontal probe
Measured: 12 months
% root coverage
Percentage of the denuded root surface which is covered following the procedure
Measured: 12 months
Gingival Thickness Gain
Thickness of the gingival following the procedure
Measured: 12 months
Gingival Volume Gain
The gingival volume gain following the procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 May 2017
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Why it stopped: The PI has left the organization
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 Southern CaliforniaThe 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 Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neema Bakhshalian, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124329
- Sponsor's protocol ID
- HS-16-00661
- Status last verified
- Jun 2019
- First submitted
- 18 Apr 2017
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The intra-oral clinical photography, CBCT scans, study models and clinical data will be shared with other investigators for data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Prospective Randomized Controlled Clinical Trial to Examine the Efficacy of Methods to Treat Multiple Gingival Recession Defects
- ClinicalTrials.gov ID
- NCT03124329
- Acronym / sponsor ID
- HS-16-00661
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI has left the organization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 21 Apr 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.
Rationale: Treatment of gingival recession defects requires coronal advancement of the gingival margin due to patient esthetic demand, tooth sensitivity and improvement of tooth prognosis, which can be accomplished either through a flap procedure or through a tunnel. It will be desirable to determine the efficacy of Vestibular Incision Subperiosteal Tunnel Access (VISTA) to Coronally Advanced Flap (CAF) procedure and intrasulcular tunneling.
Another aspect of the study is to determine whether autologous concentrate of platelets and leukocytes (leukocyte-platelet-rich fibrin; L-PRF) has equivalent efficacy to connective tissue autologous graft harvested from the palate.
The overall objective of this study is to evaluate the effectiveness of therapeutic modalities for the treatment of multiple gingival recession defects.
The study is designed as a prospective, randomized controlled clinical trial. Four groups will be compared:
Group 1: Coronally Advanced Flap (CAF) Group 2: VISTA Group 3: Intrasulcular tunneling (IST) Group 4: VISTA + L-PRF
Each of the groups will be treated without any graft material in order to examine the efficacy of coronal advancement and periodontal root coverage without the confounding variable of graft material. These techniques don't require any additional graft if there is adequate amount of keratinized gingiva
The study population will be patients who present to Advanced Graduate Program in Periodontology at the University of Southern California, USA, and are deemed to require treatment of multiple gingival recession defects. A total sample of 100 participants (23 participants per group) will provide a two sided test of means with 80% power at alpha of 0.05. The calculation was carried out using PASS Version 12 (Hintze, J. (2014). NCSS, LLC. Kaysville, Utah.)
The study duration will be 1 year. Follow-up visits after the surgery will occur after 3 days , 7 days and at weeks 3, 6, 12, 24, 36 and 52. These follow up visits consistent with standard of care follow up for gingival recession treatment and there will be no additional costs to the participant.
The Primary Outcome variable is complete root coverage; the Secondary Outcome Variables are clinical attachment level (CAL) gain, changes in gingival thickness and volume and the Tertiary Outcomes are aesthetic outcomes, postoperative pain and Patient satisfaction survey
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coronally Advanced Flap | Experimental | Procedure: Coronally Advanced Flap |
| Vestibular Incision Subperiosteal Tunnel Access (VISTA) | Experimental | Biological: Vestibular Incision Subperiosteal Tunnel Access (VISTA) |
| Intrasulcular tunneling | Experimental | Procedure: Intrasulcular Tunneling |
| VISTA + Leukocyte-Platelet Rich Fibrin | Experimental | Biological: Vestibular Incision Subperiosteal Tunnel Access (VISTA), Device: Leukocyte-Platelet Rich Fibrin (L-PRF) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female individuals between ages of 18 to 70 years old
- Multiple contiguous gingival recession defects on a minimum of two adjacent teeth, exhibiting 3mm or more recession on at least one of those teeth
- No prior surgical treatment in the sites planned for therapy
- Minimum of 2 mm of keratinized gingiva
- Absence of cervical restorations extending to the CEJ
Key exclusion criteria (11 listed)
- Molar teeth
- Milller Class 4 recession defects
- Pregnancy (Self-reported)
- Smoking
- Uncontrolled local or systemic diseases that affects wound healing (diabetes, autoimmune or inflammatory disorders)
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 |
|---|---|---|
| Coronally Advanced FlapCoronally advanced flap will be performed. Briefly, sulcular incisions will be made. Oblique incisions will be made on each papilla requiring root coverage. In the region coronal to the mucogingival junction (MGJ), mucoperiosteal flap will be elevated. Apical to the MGJ, sharp dissection will be performed to the periosteum allowing split-thickness flap elevation to be performed. Epithelium is removed from the papillae adjacent to the recession and the flap is coronally positioned and stabilized with interproximal sutures and apico-coronal interrupted sutures to close the vertical releasing incisions. | Procedure or surgery | Coronally Advanced Flap |
| Intrasulcular TunnelingInitial sulcular incisions are made and small, contoured blades and mini curettes are used to create the recipient pouches and tunnels. The tunnel will be subperiosteal in location. The incision is extended to one adjacent tooth both mesially and distally. This incision maintains the full height and thickness of the gingival component and enables access beneath the buccal gingiva. The connective tissue beyond the mucogingival line will be dissected and free the buccal flap from its insertions to the bone around each tooth. Muscle fibers and any remaining collagen fibers on the inner aspect of the flap, which prevent the buccal gingiva from being moved coronally, are cut. The papillae are kept intact and undermined to maintain their integrity and carefully released from the underlying bone, which allows the coronal positioning of the papillae. An envelope, full-thickness pouch, and tunnel are created and extended apically beyond the mucogingival line by blunt dissection | Procedure or surgery | Intrasulcular tunneling |
| Vestibular Incision Subperiosteal Tunnel Access (VISTA)The VISTA approach begins with a Vestibular Incision Subperiosteal Tunnel Access. Through this incision a subperiosteal tunnel is created, exposing the facial osseous plate and root dehiscence. This tunnel will be extended at least one or two teeth beyond the teeth requiring root coverage to mobilize gingival margins and facilitate coronal repositioning. Additionally, the subperiosteal tunnel is extended interproximally under each papilla as far as the embrasure space permits, without making any surface incisions through the papilla. The mucogingival complex is then advanced coronally and stabilized in the new position with the coronally anchored suturing technique, which entails placing a horizontal mattress suture apical to the gingival margin of each tooth. The suture is tied to position the knot at the midcoronal point of the facial aspect of each tooth, which is secured with help of composite resin to prevent apical relapse of the gingival margin during initial stages of healing. | Biological | VISTA + Leukocyte-Platelet Rich Fibrin, Vestibular Incision Subperiosteal Tunnel Access (VISTA) |
| Leukocyte-Platelet Rich Fibrin (L-PRF)Immediately prior to surgery, 72 mL of blood should be drawn from each patient by venipuncture of the antecubital vein and collected in a sterile glass test tube without any anticoagulant. Tubes should be centrifuged at 2,700 rpm for 12 minutes within 2 minutes after blood draw. For individuals on anti-coagulant therapy or supplements to interfere with coagulation, centrifugation will be for 18 minute. After centrifugation, each L-PRF clot will be separated from the portion of red blood cells (red thrombus), obtaining a fibrin clot with a red small portion in order to include the "buffy" coat richer in leucocytes. The L-PRF clot is condensed and modeled on a sterile surgical plate. L-PRF will be used within 60 minutes after the preparation. | Device | VISTA + Leukocyte-Platelet Rich Fibrin |
Primary outcome
Complete root coverage
Time frame: 12 months
Complete coverage of the recession defect following surgery. It will be a binary outcome (Yes or No)
4 secondary outcomes
Clinical Attachment Level gain
Time frame: 12 months
% root coverage
Time frame: 12 months
Gingival Thickness Gain
Time frame: 12 months
Gingival Volume Gain
Time frame: 12 months
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 15 Oct 2025.
- Individual participant dataSharing planned: Yes. The intra-oral clinical photography, CBCT scans, study models and clinical data will be shared with other investigators for data analysis.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally Advanced Flap, Intrasulcular Tunneling and Vestibular Incision Subperiosteal Tunnel Access (VISTA) in people with Gingival Recession, run by University of Southern California 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 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: withdrawn, as of the sponsor's last update on 15 Oct 2025. 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?
Complete root coverage (time frame: 12 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 15 Oct 2025.