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Study on Regenerative Treatment of Intra-bony Defects

Primary Purpose

Periodontal Disease, Periodontal Attachment Loss

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Ostim

Emdogain

About this trial

This is an interventional treatment trial for Periodontal Disease focused on measuring Periodontal disease, Hydroxyapatite, Enamel matrix protein, Regeneration, Human

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).
Conditions or circumstances , in the opinion of the investigator, that could represent a general contra-indication for surgical procedures or would prevent completion of study participation or interfere with analysis of study results, such as a history of non-compliance, or unreliability.
Local inflammation.
Mucosal diseases (e.g. erosive lichen planus).
History of local radiation therapy.
Presence of oral lesions (e.g. ulceration, malignancy).
Inadequate oral hygiene or patient who is unmotivated for home care.
Teeth with untreated endodontic or cariologic problems.
Defects that during surgery show deviation from the inclusion criteria.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Amount of bone fill after surgery

Secondary Outcome Measures

Clinical attachment level gain and reduction of probing pocket depth

Full Information

NCT ID

NCT00757159

First Posted

September 22, 2008

Last Updated

January 16, 2012

Sponsor

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT00757159

Brief Title

Study on Regenerative Treatment of Intra-bony Defects

Official Title

Randomised, Clinical Controlled Study on Treatment of Intra-bony Defects With Enamel Matrix Protein (Emdogain®) vs. Nanocrystalline Hydroxyapatite (Ostim®)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technische Universität Dresden

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Disease, Periodontal Attachment Loss

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Ostim

Other Intervention Name(s)

synthetic hydroxyapatite

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Emdogain

Other Intervention Name(s)

enamel matrix protein

Intervention Description

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

Primary Outcome Measure Information:

Title

Amount of bone fill after surgery

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Clinical attachment level gain and reduction of probing pocket depth

Time Frame

6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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). Conditions or circumstances , in the opinion of the investigator, that could represent a general contra-indication for surgical procedures or would prevent completion of study participation or interfere with analysis of study results, such as a history of non-compliance, or unreliability. Local inflammation. Mucosal diseases (e.g. erosive lichen planus). History of local radiation therapy. Presence of oral lesions (e.g. ulceration, malignancy). Inadequate oral hygiene or patient who is unmotivated for home care. Teeth with untreated endodontic or cariologic problems. Defects that during surgery show deviation from the inclusion criteria.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Hoffmann, Prof.

Organizational Affiliation

Technische Universität Dresden

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Dresden

ZIP/Postal Code

01307

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24689056

Citation

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.

Results Reference

derived

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Study on Regenerative Treatment of Intra-bony Defects

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