Clinical trial: Treatment of Post-Extraction Dehisced Socket - A Case Series Study (NCT02980211)

Eligibility criteria:
INCLUSION CRITERIA

          -  Provision of informed consent

          -  Age: 18 years or older

          -  Subjects with a single-rooted tooth indicated for extraction bounded by stable,
             natural teeth

          -  Tooth planned for extraction must have a dehiscence defect in the surrounding bone,
             observed clinically and/or radiographically, that affects at least 50% of the bone
             height

          -  Subjects must be interested in replacing the tooth with a single implant-supported
             fixed restoration

          -  Subjects must be able and willing to follow instructions related to the study
             procedures

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

        EXCLUSION CRITERIA

          -  Mandibular incisors

          -  Subjects with a history of organ failure (e.g. liver, kidney)

          -  Subjects with severe hematologic disorders, such as hemophilia or leukemia

          -  Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as
             osteoporosis, thyroid disorders or Paget's disease

          -  Subjects taking any medication or supplement known to largely influence bone
             metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or
             chronic intake of glucocorticoids

          -  Pregnant women (as indicated by positive serum HCG test) or nursing mothers

          -  Subjects with conditions that would result in compromised healing (e.g. poorly
             controlled diabetes, active heavy tobacco use [>10 cigs/day])

          -  Subjects who, at the discretion of the investigators, would be unsuitable candidates
             for the study due to safety, psychological or practical reasons (e.g. known allergies
             to any product used for the study, limited mouth opening, etc.)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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