Gingival Recession
Conditions
Keywords
Gingival phenotype, Keratinized gingiva, Gingival recession, Soft tissue recession
Brief 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. 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
Interventions
PROCEDUREVISTA
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
PROCEDURESTA
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
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM | From baseline to 6 months | Compare the increase in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM | From baseline to 6 months | Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between VISTA and STA following soft tissue grafting. |
| Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM | From baseline to 6 months | Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between VISTA and STA following soft tissue grafting. |
| Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Total of 9 participants enrolled in the study, 2 (VISTA), 1 (STA) and 6 (VISTA and STA). Randomization was performed by site in the mouth (teeth) to receive either VISTA intervention or STA intervention. As a result, some participants received one of the 2 interventions either VISTA or STA if they only had one qualifying site (teeth), while other participants received both interventions if they had multiple sites that are met the inclusion criteria. Total VISTA sites=13, total STA sites=16.
Participants by arm
| Arm | Count |
|---|---|
| VISTA VISTA incision with CAF and ADM | 2 |
| VISTA VISTA incision with CAF and ADM | 3 |
| Sulcular Tunnel Access (STA) Sulcular tunnel surgery with CAF and ADM | 1 |
| Sulcular Tunnel Access (STA) Sulcular tunnel surgery with CAF and ADM | 1 |
| VISTA + STA Both VISTA and STA (at different sites in the same patient) | 6 |
| VISTA + STA Both VISTA and STA (at different sites in the same patient) | 25 |
| Total | 38 |
Baseline characteristics
| Characteristic | VISTA | Sulcular Tunnel Access (STA) | VISTA + STA | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 | 0 / 6 |
| other Total, other adverse events | 0 / 2 | 0 / 1 | 0 / 6 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 6 |
Outcome results
Primary
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.
Time frame: From baseline to 6 months
Population: VISTA group has 2 participants who only received VISTA (number of sites=3) and has 6 participants who received VISTA (number of sites=10) total VISTA sites =13. STA group has 1 participant who only received STA (number of site=1) and has 6 participants who received VISTA and STA (number of sites=15) total STA sites=16).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VISTA | KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM | 3.15 mm | Standard Deviation 0.27 |
| Sulcular Tunnell Access | KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM | 2.23 mm | Standard Deviation 0.25 |
Secondary
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.
Time frame: 6 months
Population: VISTA group has 2 participants who only received VISTA (number of sites=3) and has 6 participants who received VISTA (number of sites=10) total VISTA sites =13. STA group has 1 participant who only received STA (number of site=1) and has 6 participants who received VISTA and STA (number of sites=15) total STA sites=16).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VISTA | Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively | 7.41 score on a scale | Standard Deviation 0.28 |
| Sulcular Tunnell Access | Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively | 7.31 score on a scale | Standard Deviation 0.29 |
Secondary
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.
Time frame: From baseline to 6 months
Population: VISTA group has 2 participants who only received VISTA (number of sites=3) and has 6 participants who received VISTA (number of sites=10) total VISTA sites =13. STA group has 1 participant who only received STA (number of site=1) and has 6 participants who received VISTA and STA (number of sites=15) total STA sites=16).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VISTA | Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM | 1.38 mm | Standard Deviation 0.14 |
| Sulcular Tunnell Access | Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM | 1.12 mm | Standard Deviation 0.1 |
Secondary
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.
Time frame: From baseline to 6 months
Population: VISTA group has 2 participants who only received VISTA (number of sites=3) and has 6 participants who received VISTA (number of sites=10) total VISTA sites =13. STA group has 1 participant who only received STA (number of site=1) and has 6 participants who received VISTA and STA (number of sites=15) total STA sites=16).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VISTA | Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM | 1.04 mm | Standard Deviation 0.045 |
| Sulcular Tunnell Access | Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM | 0.95 mm | Standard Deviation 0.031 |