OrACELL™ vs. Connective Tissue in Miller Class 3 Defects

NCT03226600 | Completed

• 1 other identifier: 2014-0833-BCD-FB
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Recession

Keywords

Gingival Recession; Connective Tissue Graft; OrACELL; Decellularized Dermis; Periodontics

Outcome Measures

Primary Outcomes (1)

• Gingival Recession (Root Coverage)

  The measurement in millimeters of the relationship of the cementoenamel junction (CEJ) to the gingival margin

  6 months

Study Arms (2)

Connective Tissue Graft

ACTIVE COMPARATOR

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

OrACELL

EXPERIMENTAL

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

Interventions

OrACELL 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.

OrACELL

Connective Tissue Graft DEVICE

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

Also known as: Subepithelial Connective Tissue Graft

Connective Tissue Graft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
• 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
• Study is limited to vital and nonvital incisors, canines, and premolars
• 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
• Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
• Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery

You may not qualify if:

• Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
• History of previous history of surgery performed at surgical sites included in study
• Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
• Non-English speakers
• Pregnant or lactating females
• Immunosuppressant medications

Sponsors & Collaborators

• Texas A&M University: lead
• LifeNet Health: collaborator

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial between two treatment modalities for gingival recession with 6 month follow-up

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: July 24, 2017
• Study Start: March 26, 2015
• Primary Completion: June 13, 2016
• Study Completion: December 16, 2016
• Last Updated: July 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share