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:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT00900718
Eligibility Criteria:
Inclusion Criteria:
* Patient must have voluntarily signed the informed consent
* Males and females, 18 years to 75 years of age
* Patient needs single tooth extraction in mandibular or maxillary incisor or pre-molar region and would benefit from prosthetic reconstruction with a dental implant
* Patients must be committed to the study and must sign informed consent
* Patient in good general health as documented by self assessment
Exclusion Criteria:
Systemic exclusion criteria
* Patient who has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation
* Female patient who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence
* Patient who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of baseline visit
* Patient who are on concomitant anticoagulant therapy of warfarin (coumadine), clopidogrel, ticlopidine or once daily asprin of more than 81 mg.
* Patient who knowingly has HIV or Hepatitis
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* Patient who has undergone administration of any investigational drug within 30 days of study initiation.
* Alcoholism or chronically drug abuse causing systemic compromisation
* Patient who is a heavy smoker (\>10/cigarettes per day).
* Patient is suffering from a known psychological disorder
* Patient has limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed
Local exclusion criteria
* Uncontrolled or untreated periodontal disease
* Bone defects that excludes implant restoration
* Patient who has a full mouth plaque level \>30 % at the enrolment visit
* Mucosal diseases such as erosive lichen planus
* History of local radiation therapy
* Presence of oral lesions (such as ulceration, malignancy)
* Severe bruxing or clenching habits
* Persistent intraoral infection
* Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
* Patient presents an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure (sites with presence of an asymptomatic chronic lesion are eligible)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00900718
Study Brief:
Protocol Section:
NCT00900718