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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03028922
• Date of registration: 10/01/2017
• Prospective Registration: No
• Primary sponsor: Nobel Biocare
• Public title: A 1-year Clinical Investigation on the the CREOS™ XENOGAIN Bone Graft SUBSTITUTE
• Scientific title: A Prospective, Multi-centre Study Evaluating Creos™ Xenogain Bone Graft Substitute in Horizontal Ridge Augmentation in the Premolar and Molar Region of the Mandible
• Date of first enrolment: October 2016
• Target sample size: 42
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03028922
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany, Italy, Serbia

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Horizontal Bone Augmentation

Intervention(s)

Device: creos xenogain

Primary Outcome(s)

Bone gain 8 months after bone augmentation procedure for implant placement. [Time Frame: 8 months]

Secondary Outcome(s)

oral health related quality of life assessment [Time Frame: 1 year]

Soft tissue outcome 1 year after definitive prosthetic delivery [Time Frame: 1 year]

Implant survival [Time Frame: 6 months and 1 year after definitive prosthetic delivery]

Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components [Time Frame: 8 months]

Implant success [Time Frame: 6 months and 1 year after definitive prosthetic delivery]

Marginal bone levels [Time Frame: 6 months and 1 year after definitive prosthetic delivery]

Secondary ID(s)

T-189

Source(s) of Monetary Support

Please refer to primary and secondary sponsors