A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.
Gingival Recession · Lack of Keratinized Gingiva
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 99 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 22 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the 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
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Single masked
Side Access Mucosal Releasing Incision (SAMRI)
SAMRI incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft
Procedure: SAMRI
Sulcular Tunnell access
Sulcular tunnel access incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft
Procedure: STA
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
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
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
Time frame: From baseline to 6 months and 12 months
Compare the change in the exposed root surface at sites with gingival recession.
Secondary measures
KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM
Time frame: From baseline to 6 and 12 months
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
Time frame: From baseline to 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
Time frame: From baseline to 6 and 12 months
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
Time frame: At 6 and 12 months postoperatively
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
Time frame: 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months 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).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
University of Alabama at BirminghamBirmingham, Alabama, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- University of Alabama at Birmingham
- Study start
- Feb 11, 2021 Actual
- Primary completion
- Dec 11, 2023 Actual
- Study completion
- 2027-08 Estimated
- First posted
- Nov 27, 2019 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study 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.
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026