Clinical Trial: Study on Regenerative Treatment of Intra-bony Defects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomised, Clinical Controlled Study on Treatment of Intra-bony Defects With Enamel Matrix Protein (Emdogain®) vs. Nanocrystalline Hydroxyapatite (Ostim®)
Brief Summary: The aim of this investigation is to determine whether a synthetic hydroxyapatite is as effective as an enamel matrix protein for periodontal regeneration in patients who have intra-bony periodontal defects.
Detailed Summary:
Regeneration of periodontal tissues that have been diminished by periodontal disease is the main goal of periodontal therapy. While conventional surgical therapy only offers limited potential towards recovering tooth-supporting tissues, more recently developed techniques lead to a greater and more predictable regeneration of the periodontal structures. Among these techniques, application of enamel matrix proteins or bone grafts can promote periodontal regeneration.
The study is a prospective, controlled, mono-center, randomized, clinical trial, that is open to the operator, blinded to the examiner. It will be conducted in a parallel group design. Participants who have at least 1 intra-bony periodontal defect will receive regenerative surgery at baseline with the randomly selected devices. A newly developed synthetically manufactured bone grafting material made of hydroxyapatite (Ostim) will be the product under investigation. An enamel matrix protein derivative (Emdogain) will act as control device. Both materials will be applied in intra-bony defects during periodontal flap surgery. Follow-ups will take place at 7 and 14 days post surgery, and at 3, 6, 9, and 12 months.
The primary aim is to compare the effectiveness of the test product with the control in the treatment of 1- and 2-wall intrabony periodontal defects on the amount of bone fill 12 months after surgery. Secondary parameters will be the clinical attachment level gain and reduction of probing pocket depth at 6 and 12 months.
Sponsor: Technische Universität Dresden
Current Primary Outcome: Amount of bone fill after surgery [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinical attachment level gain and reduction of probing pocket depth [ Time Frame: 6 and 12 months ]
Original Secondary Outcome: Same as current
Information By: Technische Universität Dresden
Dates:
Date Received: September 22, 2008
Date Started: August 2008
Date Completion:
Last Updated: January 16, 2012
Last Verified: January 2012
