Study on Regenerative Treatment of Intra-bony Defects (NCT00757159) | Clinical Trial Compass
CompletedPhase 4
Study on Regenerative Treatment of Intra-bony Defects
Germany56 participantsStarted 2008-08
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ci…