SAMRI vs STA for Gum Recession

Overseen By Maria Geisinger, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Smokers, Systemic pathologies, Active periodontal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6-12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two incision techniques for treating gum recession, a condition where gums pull back from the teeth. The researchers aim to determine which technique better covers the tooth root, improves gum thickness, and provides more comfort after surgery. One method, called SAMRI, is new and uses a simpler cut and stitch approach, while the other, known as STA, is more traditional. Ideal candidates are patients at the UAB Dental School with gum recession around one or more teeth, who do not require other dental repairs in the area. As an unphased trial, this study allows patients to contribute to innovative dental research and potentially benefit from advanced treatment techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these incision techniques are safe for treating gum recession?

Research has shown that the SAMRI technique for treating gum recession is generally safe. Patients who underwent this procedure usually found it manageable. Available research has reported no major side effects. This technique uses a simple cut-and-stitch method, potentially reducing risks compared to more complex procedures. As this treatment is in an early phase of study, the technique is still being tested for new methods. However, current evidence suggests it is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard sulcular tunnel access technique for gum recession, the Side Access Mucosal Releasing Incision (SAMRI) offers a fresh approach by allowing for a different incision method. This unique technique supports a coronally advanced flap, which is essential for effective gum coverage, and facilitates the placement of an acellular dermal matrix graft. Researchers are excited about SAMRI because it may offer improved outcomes in tissue management and healing, potentially leading to better aesthetic and functional results for patients dealing with gum recession.

What evidence suggests that this trial's techniques could be effective for gum recession?

Research has shown that the SAMRI technique, one of the treatments studied in this trial, could be a promising way to treat gum recession. In one study, SAMRI reduced gum recession by about 70%, from an average of 2.90 mm to 0.86 mm. This method effectively covers exposed roots and enhances the appearance of gums, making them look healthier and more attractive. Additionally, it may shorten surgery time and reduce postoperative pain. Overall, SAMRI has the potential to improve gum health and appearance effectively. Participants in this trial will receive either the SAMRI technique or the STA technique, another treatment option under evaluation. ^{1 2 3 6 7}

Who Is on the Research Team?

Maria Geisinger, DDS, MS

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My teeth next to the treatment area are healthy, without cavities, and my gums are in good condition.

Must be a patient of the UAB Dental School

I don't expect to need dental work on the teeth being studied.

Exclusion Criteria

I have had soft tissue grafting done on the area to be treated.

I am under 18 years old.

Smokers/tobacco users (>10 cigarettes/day)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the SAMRI or Sulcular Tunnel Access procedure with ADM grafting to treat gingival recession

6-12 months

Multiple visits for procedure and assessments

Follow-up

Participants are monitored for clinical outcomes such as root coverage, tissue thickness, and patient-centered outcomes

12 months

Regular follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• SAMRI
• STA

Trial Overview 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.

How Is the Trial Designed?

Group I: Side Access Mucosal Releasing Incision (SAMRI) Experimental Treatment 1 Intervention

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

Group II: Sulcular Tunnell access Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/10.1002/cap.10076

Treatment of Recession Defects With Mucosal Access and ... This report introduces the side access mucosal releasing incision (SAMRI) technique as an innovative and simplified method to perform ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31524323/

Treatment of Recession Defects With Mucosal Access and ... Conclusion: SAMRI procedure allows for optimal root coverage and esthetic results while limiting intrasurgical time and postoperative patient morbidity.

3. digitalcommons.library.uab.edu digitalcommons.library.uab.edu/etd-collection/119/

"A Prospective Randomized Clinical Trial to Compare Side ... Results. The mean facial recession defect at the initial exam for the SAMRI group was 2.90 ± 0.94mm which was reduced to 0.86 ± 0.65mm or 70% defect ...

4. clinicaltrial.be clinicaltrial.be/en/details/59811?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Comparison of Side Access Mucosal Releasing Incision ... Research data and daily clinical observations reveal that teeth with gingival recession and a lack of adequate keratinized tissue (KT) are ...

5. clinconnect.io clinconnect.io/trials/NCT04179448

A Comparison of Side Access Mucosal Releasing Incision This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix ...

6. trial.medpath.com trial.medpath.com/clinical-trial/d3aed524deb1c7c2/nct04179448-prospective-randomized-clinical-trial-side-access-mucosal-releasing-incision-sulcular

A Comparison of Side Access Mucosal Releasing Incision ... This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix ...

7. researchprotocols.org researchprotocols.org/2025/1/e67168

Comparative Effectiveness of Titanium Platelet-Rich Fibrin ... Objective: The objective of this study is to compare the effectiveness of T-PRF and CTGs from the tuberosity area in managing gingival recession ...