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A Prospective, Multi-centre Study Evaluating Creos™ Xenogain Bone Graft Substitute in Horizontal Ridge Augmentation in the Premolar and Molar Region of the Mandible (NCT03028922)

This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute. Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible.
  • Device: creos xenogain
    GBR procedure will be performed using creors xenogain bone graft substitute in patients that need horizontal bone augmentation prior to implant placement. The defect should be located in the pre-molar and molar region of the mandible
    Ages eligible for Study
    18 Years to 80 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Subjects between 18 and 80 years old.
    • Patient has signed informed consent to participate in the study.
    • Patients in need of horizontal ridge augmentation prior to implant placement in the premolar and posterior region of the mandible
    • Horizontal defect classified as: Horizontal medium defect (Hm) (4-6 mm defect) or Horizontal large defect (Hl) (≥7 mm defect)
    • Patients presented with a combination defect Horizontal/Vertical with a maximum of 2mm loss of vertical dimensions (minimal vertical dimension for patient inclusion is 7.5 mm defined as the distance from the anatomical landmark, alveolar nerve or lingual dehiscence)
    • The subject must be in good physical and mental condition
    • The subject is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
    • Full-mouth bleeding score (FMBS) lower than 25%.
    • Full-mouth plaque score (FMPI) lower than 25%.
    • The subject is suitable for a 2-stage surgical procedure
    Exclusion Criteria:
    • Severe bone defect classified as: Vertical medium (Vm) (4-6 mm defect) or Vertical large, (Vl) (≥7 mm)
    • Medium (Cm) and Large (Cl) classified combination defects Prior bone augmentation in the area planned for treatment (i.e ridge preservation)
    • Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
    • Any disorders directly in the planned implant area such as previous tumors, chronic bone disease.
    • Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc).
    • Alcohol or drug abuse as noted in subject records or in subject history.
    • Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history.
    • Heavy smoking (> 10 cigarettes per day).
    • Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.
    • Poor compliance.
    • Active periodontal disease involving the residual dentition.
    • Mucosal diseases in the areas to be treated.
    • Pregnant or lactating women at the time of bone augmentation procedure.
    This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute.

    Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible.

    Primary endpoint include the bone gain after 8 months healing period, while secondary endpoints includes histological analysis 8 months after performance of the augmentation procedure as well as Implant survival, implant success and marginal bone levels evaluated over a period of 1 year after definitive prosthetic delivery.

    6 locations

    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    30 September, 2016
    Updated:
    18 January, 2017
    Participants:
    42
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