Clinical trial: Alveolar Socket Healing With and Without PRGF (NCT04383158)

Eligibility criteria:
Inclusion Criteria

        All of the following criteria must be fulfilled for inclusion:

          -  Patient must have willingness to read and sign a copy of the Informed Consent Form
             Males and females, ≥25 years old.

          -  Patient in need of a single permanent tooth extraction with clinical and/or
             radiographic evidence of unrestorable maxillary premolars, canines, or incisors with
             at least one adjacent tooth present, and with periodontal attachment preserved at
             least for 2/3rd of the root nor associated with acute periapical pathology.

          -  Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be
             confirmed at Visit 2 after extraction. In case of >50% buccal bone loss, the
             participant will be withdrawn.

          -  Patient in good general health as documented by self-assessment.

          -  Full mouth bleeding and plaque scores (FMBS <10% and FMPS <20%) recorded within the
             previous 8 weeks.

        Exclusion criteria

          -  Uncontrolled or untreated periodontal disease.

          -  History of local (head and neck) radiation therapy.

          -  Presence of oral lesions in the area of the extraction (such as ulceration,
             malignancy).

          -  Severe bruxing or clenching habits.

          -  Acute endodontic lesion in the test tooth or in the neighbouring areas to the
             extraction procedure (sites with presence of an asymptomatic chronic lesion are
             eligible).

          -  Medical history that includes uncontrolled diabetes or hepatic or renal disease, or
             other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid
             arthritis, osteoporosis) or transmittable diseases (e.g. AIDS).

          -  History of alcohol or drug abuse.

          -  Smokers.

          -  Self-reported pregnancy or lactation (this criterion is due to oral tissue changes
             related to pregnancy and nursing which can affect interpretation of study results).

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with trial participation or
             investigational product administration or may interfere with the interpretation of
             trial results and, in the judgement of the investigator, would make the subject
             inappropriate for entry into this trial.

          -  Malocclusion, or collapse of the occlusal vertical dimension leading to dentoalveolar
             compensation which could interfere with ridge preservation dimensions and
             measurements.

          -  Lack of adjacent sound restored or unrestored teeth.

          -  Any male participants with facial hair (such as moustache, beard or any other
             variations of facial hair styles) and must keep their face shaven until after the
             placement of the dental implant (Visit 10).

          -  Any individuals using Botox or fillers in the face region.

        All patients to be enrolled who meet the inclusion / exclusion criteria will be asked if
        they have participated in any other interventional periodontal studies within the last 3
        months. If the patient did participate in such studies, then enrolment will be postponed
        until after 3 months wash-out period has elapsed.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 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? Contradiction