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

NCT04179448 | Active Not Recruiting

• 2 other identifiers: SAMRI IRB-300004045UAB-Perio
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM

  From baseline to 6 and 12 months

• Change in tissue thickness of the grafted sites at 6 and 12 months

  From baseline to 6 and 12 months

• Assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively

  From baseline to 6 and 12 months

• Assessed esthetic outcomes at 6 and 12 months post-operatively

  At 6 and 12 months postoperatively

• Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively

  1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively.

Study Arms (2)

Side Access Mucosal Releasing Incision (SAMRI)

EXPERIMENTAL

SAMRI incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft

Procedure: SAMRI

Sulcular Tunnell access

ACTIVE COMPARATOR

Sulcular tunnel access incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft

Procedure: STA

Interventions

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

Side Access Mucosal Releasing Incision (SAMRI)

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

Sulcular Tunnell access

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Maria Geisinger, DDS, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: February 11, 2021
• Primary Completion: December 11, 2023
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)