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

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Lack of Keratinized Gingiva; Gingival Recession

Treatments: Procedure: SAMRI; Procedure: STA

Study type: Interventional

Funder types: Other

Identifiers

NCT04179448

UAB-Perio (Other Identifier)

SAMRI IRB-300004045

Details and patient eligibility

About

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.

Full 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

Enrollment: 22 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Side Access Mucosal Releasing Incision (SAMRI)

Experimental group

Description:

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

Treatment:

Procedure: SAMRI

Sulcular Tunnell access

Active Comparator group

Description:

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

Treatment:

Procedure: STA