Clinical trial NCT03028922: A 1-year Clinical Investigation on the the CREOS™ XENOGAIN Bone Graft SUBSTITUTE
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Horizontal Bone Augmentation
Keywords: creos xenogain
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2017-01-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Bone gain 8 months after bone augmentation procedure for implant placement.
timeFrame: 8 months
Secondary outcomes:
measure: Implant survival
timeFrame: 6 months and 1 year after definitive prosthetic delivery
measure: Implant success
timeFrame: 6 months and 1 year after definitive prosthetic delivery
measure: Marginal bone levels
timeFrame: 6 months and 1 year after definitive prosthetic delivery
measure: Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components
timeFrame: 8 months
measure: Soft tissue outcome 1 year after definitive prosthetic delivery
timeFrame: 1 year
measure: oral health related quality of life assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Praxisklinik der Zahnheilkunde am Luisenhospital
city: Frankfurt
country: Germany
facility: Universitäts Klinikum Frankfurt
city: Padua
country: Italy
facility: Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova
city: Rimini
country: Italy
facility: Clinica Merli
city: Belgrade
country: Serbia
facility: Military Academy of Belgrade, Oral Surgery
city: Belgrade
country: Serbia
facility: University of Belgrade, Periodontology
Study officials:
References: