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| ID | Type | Description | Link |
|---|---|---|---|
| UAB-Perio | 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.
The SAMRI technique described is a novel technique involving a simplified incision and suturing technique and to the investigators' knowledge, this is the first study that seeks to compare this technique to other techniques for differences in clinical outcomes (percentage root coverage, resultant tissue thickness, and width of keratinized tissue) and patient-centered outcomes (post-operative pain, swelling, changes in daily activities, and patient-assessed esthetics) 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 suggest that decreased intrasurgical time and the simplified protocol of the SAMRI technique may result in improved clinical outcomes and/or a decrease in postoperative morbidity and complications as assessed by patients.
Specific aims for this project include the evaluation of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Side Access Mucosal Releasing Incision (SAMRI) | Experimental | SAMRI incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft |
|
| Sulcular Tunnell access | Active Comparator | Sulcular tunnel access incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAMRI | Procedure | Side Access Mucosal Releasing Incision (SAMRI) 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 |
|---|---|---|
| Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM | Compare the change in the exposed root surface at sites with gingival recession. | From baseline to 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM | Compare the change in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation. | From baseline to 6 and 12 months |
| Change in tissue thickness of the grafted sites at 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria 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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| 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 FGG and CTG following soft tissue grafting. |
| From baseline to 6 and 12 months |
| Assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 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. | From baseline to 6 and 12 months |
| Assessed esthetic outcomes at 6 and 12 months post-operatively | A visual analogue scale (VAS) based questionnaire regarding esthetic appearance, pain, swelling, bruising, effects on daily activities will be administered. This measurement ranges from 0-10 (0 being better and 10 being worse). | At 6 and 12 months postoperatively |
| Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively | A visual analogue scale (VAS) based questionnaire regarding esthetic appearance, pain, swelling, bruising, effects on daily activities. This measurement ranges from 0-10 (0 being better and 10 being worse). | 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively. |
| D055093 |
| Periodontal Atrophy |