A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.
Primary Purpose
Gingival Recession, Lack of Keratinized Gingiva
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAMRI
STA
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Keratinized Tissue, Keratinized Gingiva, Gingival recession, Mucogingival defect, SAMRI, Acellular Dermal Matrix, Sulcular tunnel technique, Patient-centered outcomes
Eligibility Criteria
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
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Side Access Mucosal Releasing Incision (SAMRI)
Sulcular Tunnell access
Arm Description
SAMRI incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft
Sulcular tunnel access incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in tissue thickness of the grafted sites at 6 and 12 months
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.
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.
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).
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).
Full Information
NCT ID
NCT04179448
First Posted
November 25, 2019
Last Updated
February 2, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04179448
Brief Title
A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.
Official Title
A Prospective, Randomized Clinical Trial to Compare Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access Procedures With Coronally Advanced Flap and Acellular Dermal Matrix (ADM) to Treat Gingival Recession.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
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 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:
Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
KT width at 6 and 12 month following grafting with SAMRI 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Lack of Keratinized Gingiva
Keywords
Keratinized Tissue, Keratinized Gingiva, Gingival recession, Mucogingival defect, SAMRI, Acellular Dermal Matrix, Sulcular tunnel technique, Patient-centered outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Side Access Mucosal Releasing Incision (SAMRI)
Arm Type
Experimental
Arm Description
SAMRI incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft
Arm Title
Sulcular Tunnell access
Arm Type
Active Comparator
Arm Description
Sulcular tunnel access incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft
Intervention Type
Procedure
Intervention Name(s)
SAMRI
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
STA
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
Description
Compare the change in the exposed root surface at sites with gingival recession.
Time Frame
From baseline to 6 months and 12 months
Secondary Outcome Measure Information:
Title
KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM
Description
Compare the change in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.
Time Frame
From baseline to 6 and 12 months
Title
Change in tissue thickness of the grafted sites at 6 and 12 months
Description
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.
Time Frame
From baseline to 6 and 12 months
Title
Assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively
Description
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
From baseline to 6 and 12 months
Title
Assessed esthetic outcomes at 6 and 12 months post-operatively
Description
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).
Time Frame
At 6 and 12 months postoperatively
Title
Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively
Description
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).
Time Frame
1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Geisinger, DDS, MS
Phone
996-7011
Email
migdds@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Startley, DMD
Phone
975-8711
Email
ss1971@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Geisinger, DDS, MS
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Geisinger, DDS,MS
Phone
205-934-4984
Email
miagdds@uab.edu
First Name & Middle Initial & Last Name & Degree
Sarah Startley
Phone
205-975-8711
Email
ss1971@uab.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data from this study will not be shared with other researchers outside of our research laboratory group.
Learn more about this trial
A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.
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