Study on Regenerative Treatment of Intra-bony Defects
Periodontal Attachment Loss
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Randomised, Clinical Controlled Study on Treatment of Intra-bony Defects With Enamel Matrix Protein (Emdogain®) vs. Nanocrystalline Hydroxyapatite (Ostim®)|
- Amount of bone fill after surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Clinical attachment level gain and reduction of probing pocket depth [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Ostim® is synthetically manufactured and comprises nanocrystalline hydroxyapatite. The small particle size facilitates resorption. Ostim is an aqueous watery paste and can be used to fill bone defects or to build up bony structures in the region of the jaws. Ostim is osteoconductive, facilitating bone growth. It will act as a scaffolding for the new bone. Ostim is absorbed during the healing process, in the beginning it is osseously interweaved and finally replaced by natural bone.
Other Name: synthetic hydroxyapatite
|Active Comparator: 2||
Emdogain® consists of sterile lyophilised Enamel Matrix Derivative with sterile aqueous solution of Propylene Glycol Alginate, 30 mg/ml.
Other Name: enamel matrix protein
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757159
|Dresden University of Technology, Dental School, Department of Conservative Dentistry|
|Dresden, Germany, 01307|
|Principal Investigator:||Thomas Hoffmann, Prof.||Technische Universität Dresden|