Clinical trial: Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw (NCT00820235)

Eligibility criteria:
Inclusion Criteria:

          -  Provision of informed consent

          -  At least 18 years

          -  In need of one or more single implants replacing missing or non-restorable teeth in
             the maxilla within region 14 to 24

        The following should be considered at inclusion but can not be fulfilled until at Visit 2:

          -  Edentulous for at least 5 months at study site

          -  A buccal-lingual bone width at study site of at least 5.5 mm

          -  A mesial-distal bone level distance between adjacent teeth at study site of at least
             5.5 mm

          -  A keratinized mid-buccal mucosal height of at least 2 mm at study site

          -  Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on
             natural roots without signs of periodontal bone loss (>1 mm) and/or significant soft
             tissue loss

          -  Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal
             guidance that will allow non-functional disclusion in all eccentric positions

          -  An opposing dentition with teeth, implants or prosthesis

        Exclusion Criteria:

          -  Insufficient interocclusal distance for implant placement and restoration at study
             site

          -  Tooth adjacent (mesial and/or distal) to study site is ankylosed

          -  More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest
             of bone on the adjacent teeth

          -  Site development (bone tissue) performed at less than 5 months before Visit 2 at study
             site

          -  Untreated rampant caries and/or uncontrolled periodontal disease

          -  Class II division 2 malocclusion (Edward Hartley Angle)

          -  Use of tobacco within last 6 months

          -  Uncontrolled diabetes (subjects history does not reveal the absence of control of
             insulin-dependent/non-insulin dependent Diabetes Mellitus)

          -  Current alcohol or drug abuse

          -  Systemic or local disease or condition that would compromise post-operative healing
             and/or osseointegration

          -  Use of any substance that will influence bone metabolism

          -  Need for systemic corticosteroids or any other medication that would influence
             post-operative healing and/or osseointegration

          -  History of radiation in the head and neck region

          -  Known pregnancy, pregnancy tests will be performed as per local requirements.

          -  Unable or unwilling to return for follow-up visits for a period of 5 years

          -  Unlikely to be able to comply with study procedures according to Investigators
             judgement

          -  Involvement in the planning and conduct of the study (applies to both Astra Tech staff
             or staff at the study center)

          -  Previous enrollment or randomization of treatment in the present study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? 0