Clinical trial: A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction (NCT02844569)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects must be adult males or females age 18 to 80 years (inclusive).

          -  Subjects must be able and willing to follow study procedures and instructions in
             English.

          -  Subjects must have read, understood and signed an informed consent form in English.

          -  Subjects must have a maxillary premolar, canine, lateral incisor, or central incisor
             with a restorative or periodontal hopeless prognosis (Kwok and Caton 2007), in which
             an implant is indicated without any sinus lift required.

          -  Subjects undergoing implant placement should be in adequate periodontal health prior
             to implant placement. This includes having probing depth ≤ 4 mm for all remaining
             teeth at the same quadrant of the proposed implant placement. Patients with
             periodontal probing sites with probing depths of up to 5 mm may also be included if
             bleeding on probing in these sites is absent. Each subject should be considered to be
             periodontally stable prior to the implant surgery.

        Exclusion Criteria:

          -  Individuals who have a chronic disease with oral manifestations.

          -  Individuals who exhibit gross oral pathology.

          -  The use of either antibiotics or chronic use (more than 7 days) of NSAIDs within 1
             month prior to screening examination.

          -  Individuals that require antibiotic prophylaxis prior to dental treatment.

          -  Chronic treatment (i.e. two weeks or more) with any medication known to affect
             periodontal status (e.g. phenytoin, calcium antagonists, cyclosporine, Coumadin)
             within 1 month prior to screening examination.

          -  Uncontrolled diabetes mellitus (HbA1c >7) within 3 months prior to screening
             examination.

          -  Individual with uncontrolled parafunctional habits, such as clenching and bruxing on
             objects, that could adversely impact implant survival.

          -  Individuals with a history of intravenous bisphosphonates.

          -  Individuals with active infectious diseases such as hepatitis, HIV or tuberculosis.

          -  Current cigarette smokers.

          -  Individuals who are known to be pregnant, breastfeeding or planning to become pregnant
             within 6 months.

          -  Individuals with blood disorders (hemophilia) and /or currently taking anticoagulant
             medications, such as heparin, warfarin, or clopidogrel.

          -  Individuals receiving any therapy known to affect healing, such as high dose
             corticosteroids, radiation therapy or chemotherapy.

          -  Individuals allergic to topical or local anesthesia.

          -  Individuals who require maxillary sinus augmentation prior to dental implant therapy.

          -  Individuals with dehisced, fenestrated, or fractured labial/buccal alveolar bone plate
             determined after baseline CBCT or after tooth extraction where more than 50% of the
             buccal bone height is not present. In this case, if the surgeon determines that guided
             bone regeneration (bone graft and membrane) is needed to repair the defect, it will be
             done at no cost to the subject, but the subject will be excluded from the study
             protocol.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Contradiction