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).
Phase: NA
Conditions: Gingival Recession
Sponsor: University of Alabama at Birmingham

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A prospective, randomized clinical trial to compare 
vestibular incision supraperiosteal tunnel access (VISTA) 
and sulcular tunnel access root coverage procedures with 
coronally advanced flap and acellular dermal matrix 
(ADM) to treat teeth with gingival recession and lack of 
adequate keratinized tissue. A pilot study. 
 
 
Study Protocol & Statistical Analysis Plan 
 
 
NCT03566108 
 
August 31, 2022 
 
 
 
Maria L. Geisinger, DDS, MS, Principal Investigator 
 
University of Alabama at Birmingham 
Birmingham, Al 35294 
 
 
 

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A prospective, randomized clinical trial to compare vestibular incision supraperiosteal tunnel access 
(VISTA) and sulcular tunnel access root coverage procedures with coronally advanced flap and 
acellular dermal matrix (ADM) to treat teeth with gingival recession and lack of adequate keratinized 
tissue. A pilot study. 
 
 
1. Study Protocol 1. Objectives/Specific Aims:  
This investigator-initiated study will compare two commonly used soft tissue grafting techniques 
[vestibular incision supraperiosteal tunnel access (VISTA) vs. sulcular tunnel access root coverage 
procedures with the uses of acellular dermal matrix (ADM)] to achieve coronal flap advancement 
and root coverage as well as augmentation of soft tissue at intraoral tooth sites.  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. To our knowledge, these 2 types of grafting techniques 
have not been compared in a prospective trial for differences in clinical (percentage of root 
coverage, amount of KT increase, tissue thickness increase, and practitioner-assessed esthetics) and 
patient-centered outcomes (pain, swelling, change in daily activities, and patient-assessed esthetics) 
in a controlled study.   
 
2. Materials and Method: 
Study population: 
A total of 40 patients seeking treatment at the UAB SOD Graduate Periodontology clinics will be 
recruited to participate in this study. The potential candidates will be approached during the 
treatment planning and/or pre-surgical visit in the periodontal clinic. The investigator/research staff 
will give the IRB approved consent form to the potential participants, explain the study, and obtain 
the patient demographics if the patient participate in the study.  
 
Procedures: 
Normal dental appointment: Patients that are seen at the school of dentistry for regular dental 
care and evaluation may be identified as plausible participants for the study based on the 
inclusion criteria, they will be scheduled for a screening appointment to determine eligibility for 
inclusion within the study.  Screening/baseline visit: patient’s electronic records will be reviewed 
to assess radiographic documentation. If the x-ray is at least one year old a new radiograph will 
be obtained. Two trained and calibrated examiners will conduct clinical and radiographic 
evaluations to determine eligibility according to the above criteria. Study visits and objectives 
will be explained to all participants.  IRB approved written informed consent will be obtained 
from all the participants. Photos will be obtained at the screening visit and at each subsequent 
visit (1-7) to evaluate healing of the tissue.  
 
Clinical parameters that will be captured include: 
• 
Probing depth (PD) measurements  
• 
Bleeding on probing (BOP)  
• 
Plaque Index (PI, Silness & Loe): A modification of the Silness and Loe Plaque Index will be 
used full mouth. Categories 2 and 3 from the original index will be collapsed into a single 

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category so that examiners only have to distinguish between visible plaque and plaque 
that cannot be seen but is detectable with the probe.  A single score will be recorded for 
each tooth. A single score 0 to 2 will be recorded for buccal and lingual/palatal surface of 
each tooth examined as follows: 
0 = No plaque  
1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth 
which cannot be seen with the naked eye. But only by using disclosing solution or by 
using probe. 
 2 = Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/   
 or adjacent tooth surface, which can be seen with the naked eye.   
 
• 
Gingival Index (GI, Loe and Silness) at surgical site(s). A periodontal probe will be swept 
around the tooth sulcus at a depth of 1-2 mm. The examiner will determine the status of 
tissue health. A single score will be recorded for buccal and lingual/palatal surface of each 
tooth examined as follows: 
0 = healthy tissue  
1 = mild inflammation but no bleeding 
2 = moderate inflammation with bleeding  
3 = severe inflammation with a tendency toward spontaneous bleeding 
 
• 
Width of keratinized tissue (KT) will be measured at tooth site(s) at the mid-buccal 
aspect from the mucosal margin to the mucogingival junction. 
• 
Width of attached tissue (AT) will be calculated by subtracting PD from KM 
• 
Tissue Thickness (TT1 and TT2) at the buccal mucosa will be measured during the 
surgical visit by horizontal transmucosal probing (sounding the bone) using an 
endodontic reamer after local infiltration of anesthetic prior to surgical site preparation. 
TT1 and TT2 will be measured at 2 mm and 5 mm from the mucosal margin, 
respectively.  
 
Clinical photographs of the tooth site (s) will be obtained with one digital SLR camera.  
 
Randomization: two groups (Participants will be randomized like the flip of a coin to one of the 
two groups listed.)  Randomly generated treatment groups will be printed on note cards and 
placed in sealed opaque envelopes.  Once the patient consents to participate in the study an 
envelope is opened, and the patient is then offered the allocated treatment regimen.   
 
Group 1:  will receive vestibular incision supraperiosteal tunnel access (VISTA) + 
Acellular Dermal Matrix (ADM) graft around teeth with gingival recession and lack of KT.  
 
Group 2: will receive sulcular tunnel access + Acellular Dermal Matrix (ADM) graft 
around teeth with gingival recession and lack of KT.  
 
Surgical visit (Visit 1): Patients will be anesthetized via infiltration around recipient tooth/teeth 
site(s).  Study surgeon will confirm measurements taken at baseline with relation to width of 
keratinized tissue (KT) and evaluate thickness of mucosa (TT1 and TT2) as described above.  Surgeon 
will then measure the recipient site to determine the size of graft needed and ensure that surgical 
treatment will avoid any vital structures. Soft tissue grafting procedures will include local anesthesia, 
monitoring of vital signs (bp, HR, O2 sat). Study surgeons will follow standard-of-care procedures for 
soft tissue as follows: 

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• 
Group 1: vestibular incision supraperiosteal tunnel access (VISTA) + Acellular Dermal Matrix 
(ADM) 
The tooth/teeth site(s) will be prepared utilizing a vertical vestibular incision beyond the 
mucogingival junction and split-thickness flap elevated on buccal aspect leaving a thin 
periosteum as recipient bed. Extension of the flap to the gingival margin and laterally to 
allow for adequate coronal advancement and coverage of the ADM graft material will be 
insured. Mesio-distal and apico-coronal dimensions will be measured at recipient site the 
ADM material trimmed after hydration and washing per package instruction to equal 
dimensions and uniform thickness will be performed. Exact AMD graft dimensions will be 
measured with a calibrated UNC-15 periodontal probe and its thickness will be measured 
using a caliper prior to placement within the supraperiosteal pouch at the recipient site. 
ADM graft will be secured in position and overlying flap secured in a coronal position with 
multiple suture techniques.  
 
VISTA procedure: 
 
Pt. presents with Miller Class I & II 
recession defects on upper front 
teeth.12 
 
Midline incision made and tissue 
released. 12 
 
Release extended to include all 
involved teeth. 13 
 
Acellular Dermal Matrix (ADM) is 
guided and manipulated to cover 
all root surfaces. 12 

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Tissue is repositioned at the 
desired level.  Sutures bonded to 
the front of each tooth. 12 
 
Midline incision sutured. 12 
 
12 month follow up appt. 12 
 
• 
Group 2: sulcular tunnel access + Acellular Dermal Matrix (ADM) graft 
The tooth/teeth site(s) will be prepared utilizing a papilla-sparing, sulcular incision extending 
one tooth mesial and distal to the tooth/teeth site(s) to be treated and split-thickness flap 
elevated on buccal aspect leaving a thin periosteum as recipient bed. Extension of the flap 
apically and laterally to allow for adequate coronal advancement and coverage of the ADM 
graft material will be insured. Mesio-distal and apico-coronal dimensions will be measured 
at recipient site the ADM material trimmed after hydration and washing per package 
instruction to equal dimensions and uniform thickness will be performed. Exact AMD graft 
dimensions will be measured with a calibrated UNC-15 periodontal probe and its thickness 
will be measured using a caliper prior to placement within the supraperiosteal pouch at the 
recipient site. ADM graft will be secured in position and overlying flap secured in a coronal 
position with multiple suture techniques. 
 
Table 2: Tunneling and ADM technique 
 
Pt. presents with Miller Class II and 
III recession defects.  

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Incision made on the front of each 
tooth to be treated.   
 
Elevation of the flap with blunt 
dissection to necessary level.  
 
Insertion of acellular dermal 
matrix.15  
 
Positioning of acellular dermal 
matrix with sutures overlying root 
surfaces.   
 
Flap positioned at the desired level 
and sutured into place.   
 
One month post-operative 
evaluation of healing.  
 
 
To help guard against possible infection, a pre-surgical antibiotic loading dose will be dispensed and 
prescriptions for relief of post-surgical discomfort, follow-up antibiotics and written home care 
instructions will be provided. 
 

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Follow up visits: The surgical sites will be examined at 1 week (visit 2) and 2 weeks (visit 3) after 
surgical visits and loose sutures will be removed.  Exams will then be scheduled at 1 month (visit 4), 
3 months (visit 5), 6 months (visit 6), and 1 year (visit 7).   
 
During these follow up visits the following will take place: 
 
1. Medical history review (all visits) 
 
2. Assess for adverse events experience (all visits) 
 
3. Intra-oral photographs: (all visits) 
 
4. Clinical measurements: 
The width of keratinized tissue (KT) will be assessed at visits 4, 5, 6 and 7. Tissue thickness 
(TT1 and TT2) will be evaluated at visits 5, 6 and 7.  Clinical measurements will be collected 
by calibrated examiners. Measurements from all visits will be compared to baseline in order 
to evaluate the progression of healing over time up to 12 months post-op. 
 
5. Patient satisfaction survey 
This survey will be performed at visits 2 and 4 using a visual analogue scale (VAS) based 
questionnaire regarding esthetic appearance, pain, swelling, bruising, effects on daily 
activities. Esthetic evaluation by the patient will also be assessed at visits 6 and 7. 
 
6. Pink Esthetics Score (PES) 
This standardized assessment of esthetics will be performed at visits 6 and 7 by blinded, 
calibrated examiners.  
 
7. Study participation and satisfaction survey to be completed at final study visit (visit 7) 
 
Inclusion/Exclusion Criteria: 
Inclusion Criteria 
Exclusion Criteria 
English speaking  
 
Non-English speaking 
At least 18 years old 
Less than 18 years old 
Must be a patient of the UAB Dental School  
Smokers/tobacco users (>10 cigarettes/day) 
Able to read and understand informed consent 
document. 
 
Patients with systemic pathologies or conditions 
contraindicating oral surgical procedures or adversely 
affecting wound healing. 
 
One or more adjacent teeth (up to four) with 
Miller class I or II gingival recession defects and  
2mm of KT at each site to be treated. 
 
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 periodontally healthy, non-carious 
neighboring teeth, healthy implants, or 
edentulous ridges on either side of the involved 
site(s) 
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. 
No anticipated need for restorative care at the 
teeth to be treated during the study period. 
Previous soft tissue grafting at the site(s) to be treated 

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Group Table: 
Group 
Treatment 
Number of participants 
Group 1 
Vestibular incision supraperiosteal tunnel access 
(VISTA) + Acellular Dermal Matrix (ADM) graft 
20 
Group 2 
Sulcular tunnel access + Acellular Dermal Matrix 
(ADM) graft 
20 
 
3. Study Background: 
 
Soft tissue grafting for root coverage and alteration of the quality of gingival tissue surrounding 
teeth was originally described in 1956 using a Lateral Pedicle Flap.1 Since that time, myriad 
techniques and materials have been described to improve clinical outcomes and patient 
acceptance.2-6 Systematic reviews and meta-analyses have concluded that root coverage and KT gain 
at sites with Miller class I or II defects could be reliably achieved with the use of allogeneic donor 
tissue as well as autogenous connective tissue harvested from a patient’s palate.7-9 Use of a tunnel 
technique has also been shown to demonstrate decreased post-operative discomfort when 
compared with a standard coronally advanced flap.10 Recently, there has been renewed interest in 
vestibular incisions, originally described in 191211, for the coronal advancement of gingival tissues 
with the use of graft materials due to purported decrease in post-operative discomfort and healing 
time.  
 
Given the increase in the number of procedures performed, this study seeks to compare two 
established tunneling technique procedures with the use of allogeneic soft tissue graft materials to 
evaluate clinical and patient-centered outcomes to determine if there are any notable differences in 
post-operative healing and clinical outcomes associated with each technique. 
 
 
4. Outcomes Measures 
Outcomes will be measures by an evaluation of the following: 
• 
Percentage previously visible root surface that has been covered by gingiva at 6- and 12-
months following grafting with VISTA and sulcular tunnel access with ADM as compared to 
the baseline data. 
• 
KT width as measured in mm by practitioner at 6- and 12-month following grafting with 
VISTA and sulcular tunnel access with ADM 
• 
Change in tissue thickness evaluated with gentle intrasulcular probing and level of 
transparency 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 of root coverage and soft tissue appearance 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, see attached Visual Analog Scale (VAS)  
• 
Group sample sizes of 20 and 20 achieve 92% power to detect non-inferiority using a one-
sided, two-sample t-test. The margin of non-inferiority is -1.0. The true difference between 
the means is assumed to be 0.1. The significance level (alpha) of the test is 0.025. The data 
are drawn from populations with standard deviations of 1.0 and 1.0. 

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• 
Regarding patient-centered outcomes, there is not adequate data available to complete an 
accurate sample size analysis to determine the proper N, therefore in this respect this study 
serves as a pilot study. 
 
5. Benefits: 
Benefits of this project for individual participants include enhancing periodontal soft tissue health 
and thus decreasing the risks of dentinal sensitivity, radicular (root) caries (tooth decay), and tooth 
root structure wear as well as a reduction in progressive recession and periodontal attachment loss 
at the tooth sites to be treated. Information gained from this research may be used by investigators 
to facilitate a healthier environment around teeth with gingival recession and a lack of keratinized 
tissue (KT) with therapies that are well-accepted with low post-operative morbidity. 
 
6. Risks 
The only risks associated with this protocol involve potential loss of confidentiality and 
randomization.  Precautions will be taken to ensure that patient confidentiality is maintained.  All 
records will be assigned identifying alphanumeric codes and the list linking identifying PHI to patient 
data will be kept on a password protected computer and destroyed immediately after statistical 
analysis is completed.  All surveys and consent documents will have assigned non-identifying, alpha-
numeric codes and the list linking personal information and patient data will be kept on a password 
protected computer and destroyed immediately after data analysis have been completed.  Intra-oral 
photos will also be assigned alphanumeric codes that link with codes assigned to the demographic 
data collection form and consent documents.  Photos will be stored as digital images on encrypted 
computers in the department of Periodontology. The photos will be used in the publication and 
presentations.  
Regarding the randomization risk, patients will be assigned to a group by chance, which may prove 
to be less effective than the other.  Both surgical techniques to be tested have been shown to result 
in clinical improvements in root coverage and soft tissue quality. There is a chance that one 
procedure may have a risk of increased post-operative discomfort, although there is considerable 
variability in patient reported discomfort after having received the same treatment with either 
group.  
Regarding procedural risks, due to each subject's physical and dental conditions being unique, the 
success of tissue grafting cannot be guaranteed. Some discomfort after treatment can be 
expected. This may include pain, bleeding, inflammation, and soreness. These discomforts can 
be expected to go away within approximately 48 hours. The treatment site could become infected. If 
an infection occurs, the study dentist will treat the area. 
Risks associated with use acellular dermal matrix (both groups) include a low, theoretical possibility of 
viral or prion contamination of the materials. No such contamination has ever been reported and ADM 
has been used in many medical and dental applications. ADM is processed from cadaveric donor skin 
and all donors are tested for nondetectable levels of HIV and HepC. Furthermore, it is processed using 
proprietary methods to removal all cells and cellular components (and this is histologically verified for 
each processing batch) to allow the collagenous and extracellular framework to remain without the cells 
which may produce antigenicity.  
Risks associated with dental anesthesia include injury to nerves, which may cause numbness or 
tingling of the lips, other teeth, chin, face, and tongue.  This is usually temporary but could be 
permanent. The mouth, lips and tongue may remain numb for up to four hours after the treatment. 
During this time there may be difficulty eating, drinking, speaking, and smiling. 
Some subjects may experience sensitivity or allergy to the anti-bacterial mouth rinse, the local 
anesthesia, the antibiotics given, or the post-treatment medications prescribed.  
A major side effect of the anti-bacterial mouth rinse is staining of the teeth. This stain is similar to 
stains left by coffee or tea, or by smoking and may be removed by professional teeth cleaning. A less 

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frequent side effect may include temporary changes in taste. This will disappear once use of the rinse 
is stopped. 
There may be other risks that are unknown. 
7. Confidentiality 
Data will be stored in a password-protected study-specific computer database within the 
department of Periodontology. Photographs of the teeth and gums will not be individually 
identifiable.  The computer is backed-up by UAB IT. Knowledge of passwords and access to the 
database will be strictly limited to study personnel who are working with the collected data.