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

22 Participants Needed

Trial Summary

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 is the purpose of this trial?

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.

Research Team

Maria Geisinger, DDS, MS

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+