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| ID | Type | Description | Link |
|---|---|---|---|
| UAB Periodontology | Other Identifier | University of Alabama at Birmingham |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VISTA | Experimental | VISTA incision with CAF and ADM |
|
| Sulcular Tunnell access | Active Comparator | Sulcular tunnel surgery with CAF and ADM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VISTA | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 6 months |
| Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria L Geisinger, DDS, MS | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0007 | United States |
Data from this study will not be shared with other researchers outside of our research laboratory group.
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | VISTA Only | VISTA incision with CAF and ADM |
| FG001 | Sulcular Tunnel Access (STA) Only | Sulcular tunnel surgery with CAF and ADM |
| FG002 | VISTA + STA: STA | Both VISTA and STA (at different sites in the same patient) |
| FG003 | VISTA + STA; VISTA | Both VISTA and STA (at different sites in the same patient) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VISTA | VISTA incision with CAF and ADM |
| BG001 | Sulcular Tunnel Access (STA) | Sulcular tunnel surgery with CAF and ADM |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | mm | From baseline to 6 months | site (teeth) | site (teeth) |
|
baseline to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VISTA Only | VISTA incision with CAF and ADM VISTA: 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 |
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Randomization was performed by site (teeth) due to challenges recruiting sufficient participants for both arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Geisinger, PI, Professor, Director of Advanced Education in Periodontology | University of Alabama at Birmingham | 205-934-4984 | miagdds@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2022 | Sep 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| STA | Procedure | 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 |
|
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between VISTA and STA following soft tissue grafting. |
| 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. | 6 months |
| BG002 | VISTA + STA | Both VISTA and STA (at different sites in the same patient) |
| BG003 | Total | Total of all reporting groups |
| site (teeth) |
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| Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| OG001 | Sulcular Tunnell Access | Sulcular tunnel surgery with CAF and ADM STA: 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 |
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | mm | From baseline to 6 months | site (teeth) | site (teeth) |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | mm | From baseline to 6 months | site (teeth) | site (teeth) |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | 6 months | site (teeth) | site (teeth) |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Sulcular Tunnell Access(STA) Only | Sulcular tunnel surgery with CAF and ADM STA: 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 | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | VISTA+STA | Both VISTA and STA (at different sites in the same patient) | 0 | 6 | 0 | 6 | 0 | 6 |
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| D055093 |
| Periodontal Atrophy |