A 1-year Clinical Investigation on the the CREOS™ XENOGAIN Bone Graft SUBSTITUTE
- Conditions
- Horizontal Bone Augmentation
- Interventions
- Device: creos xenogain
- Registration Number
- NCT03028922
- Lead Sponsor
- Nobel Biocare
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description creos xenogain creos xenogain Patients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute
- Primary Outcome Measures
Name Time Method Bone gain 8 months after bone augmentation procedure for implant placement. 8 months To evaluate bone gain 8 months after bone augmentation procedure for implant placement.
- Secondary Outcome Measures
Name Time Method Implant survival 6 months and 1 year after definitive prosthetic delivery To demonstrate cumulative survival rate of the implants placed in the augmented bone at 6 months and at 1 year after definitive prosthetic delivery.
Implant success 6 months and 1 year after definitive prosthetic delivery To demonstrate cumulative success rate of the implants placed in the augmented bone at 6 months and 1 year after definitive prosthetic delivery.
Marginal bone levels 6 months and 1 year after definitive prosthetic delivery 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
oral health related quality of life assessment 1 year To demonstrate pre- and postoperatively the oral health related quality of life assessment using the Oral Health Impact Profile questionnaire (OHIP-14).
Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components 8 months 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
Soft tissue outcome 1 year after definitive prosthetic delivery 1 year Soft tissue outcome is a combination of different parameters that include gingival index, bleeding index, keratinized mucosa and pink esthetic score
Trial Locations
- Locations (6)
Praxisklinik der Zahnheilkunde am Luisenhospital
🇩🇪Aachen, Germany
Universitäts Klinikum Frankfurt
🇩🇪Frankfurt, Germany
Military Academy of Belgrade, Oral Surgery
🇷🇸Belgrade, Serbia
University of Belgrade, Periodontology
🇷🇸Belgrade, Serbia
Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova
🇮🇹Padua, Italy
Clinica Merli
🇮🇹Rimini, Italy