Study on Regenerative Treatment of Intra-bony Defects

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00757159
Study type	Interventional
Source	Technische Universität Dresden
Contact
Status	Completed
Phase	Phase 4
Start date	August 2008
Completion date	January 2012

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.