NCT02206009

Brief Summary

Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

July 30, 2014

Last Update Submit

January 5, 2016

Conditions

Localized Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Change in depth of keratinized tissue

    The amount of gingival augmentation will be assessed by the depth of keratinized tissue, measured in millimeters. Change in the amount of keratinized tissue in the areas of interest from baseline to 6 months will be tested to see if they are statistically significant.

    baseline, approximately 6 months after the procedure

Study Arms (1)

Collagen membrane

EXPERIMENTAL

First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.

Device: Collagen Membrane

Interventions

Collagen MembraneDEVICE

First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.

Also known as: PriMatrix
Collagen membrane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have one to three consecutive teeth with recession and less than 1 mm of keratinized gingiva

You may not qualify if:

  • Asthma
  • Pregnancy
  • Uncontrolled diabetes
  • Use of continuous positive airway pressure (CPAP) machine for sleep apnea
  • Oral appliances (removable partial dentures, braces, mandibular advancement, bruxism splints, etc.)
  • Tobacco use
  • Immunocompromised individual

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Daniel Assad, DDS

    Mayo Clinic

    STUDY DIRECTOR

  • Lauren MF Syrowik, DDS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 1, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

US(1)