A 1-year Clinical Investigation on the the CREOS™ XENOGAIN Bone Graft SUBSTITUTE

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

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.

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.

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.