OrACELL™ vs. Connective Tissue in Miller Class 3 Defects

NCT ID: NCT03226600

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-26
• Study Completion Date: 2016-12-16

Brief 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.

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Connective Tissue Graft

Intervention Type: DEVICE

A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession

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.

Group Type: EXPERIMENTAL

OrACELL

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Connective Tissue Graft

A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession

Intervention Type: DEVICE

Other Intervention Names

Subepithelial Connective Tissue Graft

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LifeNet Health

INDUSTRY

Sponsor Role: collaborator

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2014-0833-BCD-FB

Identifier Type: -

Identifier Source: org_study_id