Clinical Trial: A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective, Randomized, Controlled Pilot Study of CelTx(TM) (Apligraf®) as an Alternative to Tissue From the Palate in the Treatment of Gingival Recession Requirin

Brief Summary: The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.

Detailed Summary:
Sponsor: Organogenesis

Current Primary Outcome: Overall Rate of Adverse Events (AEs) [ Time Frame: 6-month ]

Adverse events were collected at every visit throughout the 6 month duration.

An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.



Original Primary Outcome: To assess the safety of CelTx in the treatment of gingival recession requiring root coverage [ Time Frame: 6-month ]

Current Secondary Outcome:

  • Periodontal Health Measures [ Time Frame: 6-months ]
  • Aesthetic Measures [ Time Frame: 6-months ]
  • Post-Surgical Subject Comfort Measures [ Time Frame: 4-weeks ]
  • Subject Preference Measures [ Time Frame: 6-months ]


Original Secondary Outcome: Same as current

Information By: Organogenesis

Dates:
Date Received: May 14, 2008
Date Started: May 2008
Date Completion:
Last Updated: January 9, 2012
Last Verified: January 2012