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

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ClinicalTrials.gov Identifier: NCT03028922
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Horizontal Bone Augmentation Device: creos xenogain Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
creos xenogain
Patients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute
Device: creos xenogain
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




Primary Outcome Measures :
  1. Bone gain 8 months after bone augmentation procedure for implant placement. [ Time Frame: 8 months ]
    To evaluate bone gain 8 months after bone augmentation procedure for implant placement.


Secondary Outcome Measures :
  1. Implant survival [ Time Frame: 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.

  2. Implant success [ Time Frame: 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.

  3. Marginal bone levels [ Time Frame: 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

  4. 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 ]
    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

  5. Soft tissue outcome 1 year after definitive prosthetic delivery [ Time Frame: 1 year ]
    Soft tissue outcome is a combination of different parameters that include gingival index, bleeding index, keratinized mucosa and pink esthetic score

  6. oral health related quality of life assessment [ Time Frame: 1 year ]
    To demonstrate pre- and postoperatively the oral health related quality of life assessment using the Oral Health Impact Profile questionnaire (OHIP-14).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028922


Contacts
Contact: Yanela Gonzalez, MSC +41798767746 yanela.gonzalez@nobelbiocare.com
Contact: Isabelle Arrighi, Dr. +41 792 04 85 72 isabelle.arrighi@nobelbiocare.com

Locations
Germany
Praxisklinik der Zahnheilkunde am Luisenhospital Recruiting
Aachen, Germany, 52064
Contact: Bastian Wessing, DDS    +49 151 5888 7689    bastian.wessing@googlemail.com   
Universitäts Klinikum Frankfurt Not yet recruiting
Frankfurt, Germany, 60596
Contact: Robert Sader, DDS    +49 069 6301 3744    r.sader@em.uni-frankfurt.de   
Contact: Jonas Lorenz, Dr.    +496963015879    Jonas.Lorenz@kgu.de   
Sub-Investigator: Shahram Ghanaati, Dr.         
Italy
Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova Recruiting
Padua, Italy, 35128
Contact: Eriberto Bressan, Prof. DDS    +39 0434 648026    eriberto.bressan@unipd.it   
Sub-Investigator: Luca De Stavola, Dr.         
Sub-Investigator: Andrea Fincato, Dr.         
Clinica Merli Recruiting
Rimini, Italy, 47923
Contact: Mauro Merli, Prof. DDS    +39 335 6003652    mauromerli@gmail.com   
Serbia
Military Academy of Belgrade, Oral Surgery Not yet recruiting
Belgrade, Serbia, 11 000
Contact: Zoran Lazic, Prof. DDS    +381 63 372 041    lazicziv@gmail.com   
University of Belgrade, Periodontology Not yet recruiting
Belgrade, Serbia, 11000
Contact: Zoran Aleksic, Prof. DDS    +381 63 257 025    dr.zoran.aleksic@gmail.com   
Sponsors and Collaborators
Nobel Biocare

Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT03028922     History of Changes
Other Study ID Numbers: T-189
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Keywords provided by Nobel Biocare:
creos xenogain