OrACELL™ vs. Connective Tissue in Miller Class 3 Defects

Gingival Recession Clinical Trial

Official title:

A COMPARATIVE STUDY OF ROOT COVERAGE USING OrACELL™ VERSUS SUBEPITHELIAL CONNECTIVE TISSUE GRAFT: A RANDOMIZED CONTROLLED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226600
• Other study ID #: 2014-0833-BCD-FB
• Status: Completed
• Phase: N/A
• First received: May 31, 2017
• Last updated: July 20, 2017
• Start date: March 26, 2015
• Est. completion date: December 16, 2016

Study information

• Verified date: May 2017
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.

Description:

Twenty-four non-smoking, healthy patients, with 2mm or greater facial gingival recession at a minimum of one site that classified as a Miller Class I, II, or III recession defect were included. Patients were randomly assigned to either control (CTG) or OrACELL™ (test) groups, which were treated with identical surgical techniques. All root coverage clinical parameters were evaluated at baseline, 3-, and 6-months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 16, 2016
• Est. primary completion date: June 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites

2. The defect must be at least 2mm in length, (measured from the CEJ to the midfacial gingival margin) and classified as either Miller Class I, II or III

3. Study is limited to vital and nonvital incisors, canines, and premolars

4. If teeth adjacent to the site to be treated had recession as well, they were included in the grafting procedure but not included in measurement

5. Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention

6. Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery

Exclusion Criteria:

1. Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy

2. History of previous history of surgery performed at surgical sites included in study

3. Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery

4. Non-English speakers

5. Pregnant or lactating females

6. Immunosuppressant medications

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Device:
• OrACELL
OrACELL is human dermis that undergoes the MATRACELL process. MATRACELL is a patented and validated process that renders allograft tissue acellular, without compromising the biomechanical or desired biochemical properties of an allograft bio-implant for its intended surgical application.
• Connective Tissue Graft
A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	LifeNet Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival Recession (Root Coverage)	The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin	6 months