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SAMRI vs STA for Gum Recession

N/A
Waitlist Available
Led By Maria Geisinger, DDS, MS
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)
At least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively.
Awards & highlights

Study Summary

This trial will compare two incision designs for gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix graft around teeth with gingival recession and a lack of adequate keratinized gingiva.

Who is the study for?
This trial is for patients at the UAB Dental School, 18 years or older, with mild to moderate gum recession and insufficient keratinized tissue around certain teeth. Candidates must understand English and consent forms, have healthy neighboring teeth or implants, and not require other dental treatments during the study. Smokers and those with systemic health issues affecting healing are excluded.Check my eligibility
What is being tested?
The study compares two surgical techniques for treating gum recession: Side Access Mucosal Releasing Incision (SAMRI) versus Sulcular Tunnel Access (STA), both using acellular dermal matrix grafts. It aims to evaluate which method provides better root coverage, tissue thickness, patient comfort, and aesthetic outcomes.See study design
What are the potential side effects?
Potential side effects may include post-operative pain, swelling in the treated area, temporary changes in daily activities due to recovery from surgery, and possible dissatisfaction with the appearance if esthetic expectations are not met.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My teeth next to the treatment area are healthy, without cavities, and my gums are in good condition.
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I am 18 years old or older.
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I don't expect to need dental work on the teeth being studied.
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I have gum recession on 1-4 teeth with thin gums in those areas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
Secondary outcome measures
Assessed esthetic outcomes at 6 and 12 months post-operatively
Assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively
Change in tissue thickness of the grafted sites at 6 and 12 months
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Side Access Mucosal Releasing Incision (SAMRI)Experimental Treatment1 Intervention
SAMRI incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft
Group II: Sulcular Tunnell accessActive Control1 Intervention
Sulcular tunnel access incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,290 Total Patients Enrolled
Maria Geisinger, DDS, MSPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

SAMRI Clinical Trial Eligibility Overview. Trial Name: NCT04179448 — N/A
Gum Recession Research Study Groups: Side Access Mucosal Releasing Incision (SAMRI), Sulcular Tunnell access
Gum Recession Clinical Trial 2023: SAMRI Highlights & Side Effects. Trial Name: NCT04179448 — N/A
SAMRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04179448 — N/A
Gum Recession Patient Testimony for trial: Trial Name: NCT04179448 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are young adults between the ages of 18 and 30 permissible to join this study?

"To be accepted into this clinical trial, applicants must fall between the ages of 18-99. Those under 18 can partake in 2 related studies and those over 65 have 22 different options available to them."

Answered by AI

What is the magnitude of participation in this research endeavor?

"Affirmative. According to information held on clinicaltrials.gov, this investigation is actively recruiting volunteers and was initially posted on February 11th 2021 with updates made as recently as July 2nd 2022. This research project necessitates 40 individuals from a single medical site."

Answered by AI

Who is eligible to participate in this experiment?

"This medical trial is seeking 40 participants, aged between 18 and 99 who have suffered gingival atrophy. In order to be eligible, they must also possess periodontally healthy teeth adjacent to the affected area, no requirement for restorative care during the time of the study, and be a patient at UAB Dental School."

Answered by AI

Are recruitment efforts underway for this research endeavor?

"The most recent clinicaltrials.gov entry confirms that this trial is currently looking for participants since its initial posting on the 11th of February 2021, and after its last revision made at the start of July 2022."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’m 68 YTD old I just have my upper 8 theeth I. Front and 9 teeth in my lower front ID love to be able to have some implants or help with th receding gums.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.
Maria L. Geisinger, DDS, MS 2021. "A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04179448.
~5 spots leftby Apr 2025
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