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OpenTrials
Completed

NCT Number: NCT03226600

OrACELL™ vs. Connective Tissue in Miller Class 3 Defects

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Connective Tissue Graft

Device

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

Primary outcomes

  1. Gingival Recession (Root Coverage)

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • LifeNet Health

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2017
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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