Clinical trial NCT04179448: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
timeFrame: From baseline to 6 months and 12 months
Secondary outcomes:
measure: KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM
timeFrame: From baseline to 6 and 12 months
measure: Change in tissue thickness of the grafted sites at 6 and 12 months
timeFrame: From baseline to 6 and 12 months
measure: Assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively
timeFrame: From baseline to 6 and 12 months
measure: Assessed esthetic outcomes at 6 and 12 months post-operatively
timeFrame: At 6 and 12 months postoperatively
measure: Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively
timeFrame: 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Maria Geisinger, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: