Status:
COMPLETED
Study on Regenerative Treatment of Intra-bony Defects
Lead Sponsor:
Technische Universität Dresden
Conditions:
Periodontal Disease
Periodontal Attachment Loss
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 de...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00757159
Start Date
August 1 2008
End Date
January 1 2012
Last Update
January 18 2012
Active Locations (1)
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1
Dresden University of Technology, Dental School, Department of Conservative Dentistry
Dresden, Germany, 01307