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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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
Praxisklinik der Zahnheilkunde am Luisenhospital
Aachen, Germany
Universitäts Klinikum Frankfurt
Frankfurt, Germany
Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova
Padua, Italy
Clinica Merli
Rimini, Italy
Bone gain 8 months after bone augmentation procedure for implant placement.
To evaluate bone gain 8 months after bone augmentation procedure for implant placement.
Time frame: 8 months
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.
Time frame: 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.
Time frame: 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
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
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
Time frame: 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
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Military Academy of Belgrade, Oral Surgery
Belgrade, Serbia
University of Belgrade, Periodontology
Belgrade, Serbia
Time frame: 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).
Time frame: 1 year