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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Horizontal Bone Augmentation

Intervention / Treatment
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* Device: creos xenogain


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: creos xenogain<br>Patients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute | Device: creos xenogain<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone gain 8 months after bone augmentation procedure for implant placement. | To evaluate bone gain 8 months after bone augmentation procedure for implant placement. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | To demonstrate cumulative survival rate of the implants placed in the augmented bone at 6 months and at 1 year after definitive prosthetic delivery. | 6 months and 1 year after definitive prosthetic delivery | 
| Implant success | To demonstrate cumulative success rate of the implants placed in the augmented bone at 6 months and 1 year after definitive prosthetic delivery. | 6 months and 1 year after definitive prosthetic delivery | 
| Marginal bone levels | To demonstrate the changes in marginal bone levels (ΔMBL) around the implants placed in the augmented bone as measured and evaluated by periapical films, 6 months and 1 year after definitive prosthetic delivery | 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 | A bone sample using a trephine bur will be collected after 8 months and prior to implant insertion in order to perform histological analysis. The analysis will include the following parameters: percentage of vital bone and residual graft and connective tissue and if present other non bone components | 8 months | 
| Soft tissue outcome 1 year after definitive prosthetic delivery | Soft tissue outcome is a combination of different parameters that include gingival index, bleeding index, keratinized mucosa and pink esthetic score | 1 year | 
| oral health related quality of life assessment | To demonstrate pre- and postoperatively the oral health related quality of life assessment using the Oral Health Impact Profile questionnaire (OHIP-14). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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creos xenogain