Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT00757159
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00757159
Study Brief:
Protocol Section:
NCT00757159