NCT04614350

Pilot Study for Healing and Safety Outcomes in Gingival Recession

A Pilot Study For Healing And Safety Outcomes In Creating Site Appropriate Keratinized Tissue Comparing Markman Biologics Microsurfaced ADM And AlloDerm ADM

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: McGuire Institute · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Prospective, randomized, within subjects-controlled design

Detailed description

The objective of this trial is to evaluate clinical healing outcomes of microsurfaced cadaveric ADM (Markman Biologics) used in sites with \< 1 mm of attached gingiva requiring soft tissue grafting without root coverage as compared to control cadaveric ADM (AlloDerm, LifeCell) over 180-day post-op period. During the treatment period, each site will be monitored for soft tissue healing and augmentation of keratinized tissue width. All subjects will be seen at post-op day 7, 14, 30, 90, and 180.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
BIOLOGICAL	Markman Biologics Microsurfaced ADM	an ADM which has been scored (microsurfaced)
BIOLOGICAL	AlloDerm	AlloDerm tissue matrix

Timeline

• Start date: 2020-10-30
• Primary completion: 2022-02-25
• Completion: 2022-06-30
• First posted: 2020-11-04
• Last updated: 2022-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study