A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gingival Recession; Lack of Keratinized Gingiva
• Intervention / Treatment: Procedure: STA; Procedure: SAMRI

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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Geisinger, DDS, MS; Phone Number: 996-7011; Email: migdds@uab.edu
• Study Contact Backup: Name: Sarah Startley, DMD; Phone Number: 975-8711; Email: ss1971@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Side Access Mucosal Releasing Incision (SAMRI); SAMRI incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft	Procedure: SAMRI; 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
Active Comparator: Sulcular Tunnell access; Sulcular tunnel access incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Maria Geisinger, DDS, MS, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): December 11, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Gingival recession; Keratinized Tissue; Patient-centered outcomes; Acellular Dermal Matrix; Keratinized Gingiva; Mucogingival defect; SAMRI; Sulcular tunnel technique
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: SAMRI IRB-300004045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data from this study will not be shared with other researchers outside of our research laboratory group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No