Thick vs. Thin Acellular Dermal Matrix (ADM) | NCT03392038

Studies
Thick vs. Thin Acellular Dermal Matrix (ADM)

NCT03392038

Sponsor

University of Louisville

Status

Completed

Last Update Posted

Sep 10, 2020Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Gingival Recession

Interventions

Thin ADM
Thick ADM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2017Actual

Primary Completion Date

Aug 21, 2018Actual

Completion Date

Aug 21, 2018Actual

First Submitted Date

Dec 31, 2017

First Submission Date that Met QC Criteria

Dec 31, 2017

First Posted Date

Jan 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2020

Last Update Posted Date

Sep 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thin ADM	Experimental	Periodontal root coverage surgery using a coronally positioned tunnel and thin acellular dermal matrix (ADM GBR)	Procedure: Thin ADM
Thick ADM	Active Comparator	Periodontal root coverage surgery using coronally positioned tunnel surgery and thick acellular dermal matrix graft (ADM)	Procedure: Thick ADM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thin ADM	Procedure	Use of soft tissue allograft for root coverage	Thin ADM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent root coverage	Between 0 and 100%	Six months

Secondary Outcomes

Measure	Description	Time Frame
Creeping Attachment	Amount in millimeters	Six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). B. The mucogingival defect must be on a non-molar tooth. C. Patients must be ≥ 18 years of age.

Exclusion Criteria:

A. Patients with debilitating systemic or diseases that significantly affect the periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis. D. Root surface restorations at the site of recession. E. No detectable CEJ F. Patients who fail to maintain acceptable oral hygiene levels at the test and adjacent teeth.

G. Patients who are pregnant or lactating. H. Patients who use tobacco products (smoking or smokeless tobacco). I. Patients with alcohol abuse problems. J. Patients undergoing long-term steroid therapy. K. History of previous root coverage procedures, graft or GTR, on the test teeth.

L. Patients who fail to complete the informed consent form.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Henry Greenwell	University of Louisville	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Graduate Periodontics, UofL School of Dentistry		Louisville	Kentucky	40202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases