OrACELL™ vs. Connective Tissue in Miller Class 3 Defects

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Device: Connective Tissue Graft; Device: OrACELL

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Connective Tissue Graft; Connective Tissue is harvested from the palate of the subject then placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the connective tissue graft and the recession.	Device: Connective Tissue Graft; A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession; Other Names: Subepithelial Connective Tissue Graft
EXPERIMENTAL: OrACELL; Allograft Tissue (human dermis) is removed from packing and placed over the recession defect on the facial of the designated tooth. A coronally advanced flap is raised to cover the OrACELL graft and the recession.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Recession (Root Coverage)	The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin	6 months

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: LifeNet Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 26, 2015
• Primary Completion (ACTUAL): June 13, 2016
• Study Completion (ACTUAL): December 16, 2016

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (ACTUAL): July 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Periodontics; Gingival Recession; Connective Tissue Graft; OrACELL; Decellularized Dermis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 2014-0833-BCD-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No