Study on Regenerative Treatment of Intra-bony Defects

NCT00757159 | Completed Phase 4

• 1 other identifier: ZER-PA_01-2008
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease; Periodontal Attachment Loss

Keywords

Periodontal disease; Hydroxyapatite; Enamel matrix protein; Regeneration; Human

Outcome Measures

Primary Outcomes (1)

• Amount of bone fill after surgery

  12 months

Secondary Outcomes (1)

• Clinical attachment level gain and reduction of probing pocket depth

  6 and 12 months

Study Arms (2)

1

EXPERIMENTAL

Device: Ostim

2

ACTIVE COMPARATOR

Device: Emdogain

Interventions

Ostim DEVICE

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.

Also known as: synthetic hydroxyapatite

1

Emdogain DEVICE

Emdogain® consists of sterile lyophilised Enamel Matrix Derivative with sterile aqueous solution of Propylene Glycol Alginate, 30 mg/ml.

Also known as: enamel matrix protein

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged between 18 and 70 years.
• Presence of at least one 1- or 2-wall intrabony periodontal defect.
• Defect width at least 2 mm.
• Defect depth at least 4 mm.
• Defect located at a single rooted tooth or at the approximal site of a multi-rooted tooth if the tooth is not affected by a furcation involvement.
• Written informed consent.
• Subject must be judged healthy by the investigator at the time of surgery.
• Subjects must have had a plaque index \< 0.8 at the end of the initial periodontal therapy.

You may not qualify if:

• Medical conditions required prolonged use of steroids.
• Standard blood tests performed by the medical practitioner showing leukocyte dysfunction and deficiencies.
• History of haemophilia, bleeding disorders, or cumarin therapy.
• History of neoplastic disease requiring the use of chemotherapy.
• History of radiation therapy of the head and neck.
• History of renal failure or chronic renal diseases.
• Chronic liver diseases.
• Severe or uncontrolled metabolic bone disorders.
• Uncontrolled endocrine disorders (including diabetes).
• Current pregnancy at the time of recruitment.
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
• Use of any investigational drug or device within the 90 day period prior to surgery on study day 0.
• Alcoholism or chronical drug abuse.
• Immuno-compromised patients (including HIV).
• Smokers (occasional smoking is allowed).

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Dresden University of Technology, Dental School, Department of Conservative Dentistry

Dresden, 01307, Germany

Location

Related Publications (1)

• Al Machot E, Hoffmann T, Lorenz K, Khalili I, Noack B. Clinical outcomes after treatment of periodontal intrabony defects with nanocrystalline hydroxyapatite (Ostim) or enamel matrix derivatives (Emdogain): a randomized controlled clinical trial. Biomed Res Int. 2014;2014:786353. doi: 10.1155/2014/786353. Epub 2014 Feb 9.

  PMID: 24689056 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Thomas Hoffmann, Prof.

  Technische Universität Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

DE (1)