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A 5 Year Clinical Investigation on Creos Xenoprotect (CXP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373787
Recruitment Status : Terminated (Business reasons)
First Posted : February 27, 2015
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare

Tracking Information
First Submitted Date  ICMJE October 20, 2014
First Posted Date  ICMJE February 27, 2015
Last Update Posted Date November 13, 2017
Study Start Date  ICMJE July 2013
Actual Primary Completion Date January 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2015)
To demonstrate bone regeneration through measurement of defect height [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2015)
Adverse events (AEs) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 19, 2015)
  • Membrane Dehiscence [ Time Frame: 6 months ]
  • success and survival rates of implants [ Time Frame: 5 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A 5 Year Clinical Investigation on Creos Xenoprotect
Official Title  ICMJE A 5 Year Clinical Investigation on Creos Xenoprotect
Brief Summary A 5-year clinical investigation on creos xenoprotect
Detailed Description Randomized, prospective, multi-center study evaluating creos xenoprotect versus Bio-Gide® for guided bone regeneration in dehiscence defects
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Implant
Intervention  ICMJE
  • Device: creos xenoprotect
    Implant placement with simultaneous bone augmentation
  • Device: Bio-Gide
    resorbable collagen membrane
Study Arms  ICMJE
  • Experimental: creos xenoprotect
    resorbable collagen membrane
    Intervention: Device: creos xenoprotect
  • Active Comparator: Bio-Gide
    Bio-Gide, resorbable collagen membrane
    Intervention: Device: Bio-Gide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 9, 2017)
49
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2015)
40
Actual Study Completion Date  ICMJE October 2, 2017
Actual Primary Completion Date January 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Obtained informed consent from the subject.
  • The subject shall be at least 18 years of age and has passed cessation of growth.
  • The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems.
  • The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
  • The subject requires a single unit implant restoration with guided bone regeneration in bony defects in the anterior and premolar areas of maxilla or mandible.
  • If two or more site single unit implant restorations requiring bone augmentation are required, only one will be included in the study, the other site will be treated with standard of care.
  • The subject shall be healthy and compliant with good oral hygiene.
  • Full-mouth bleeding score (FMBS) lower than 25% [20].
  • Full-mouth plaque score (FMPI) lower than 20% [21].
  • The implant site is free from infection and extraction remnants.
  • The subject shall have a favourable and stable occlusal relationship.
  • Natural roots are adjacent to implant site.
  • The subject is suitable for a 2-stage surgical procedure. Secondary inclusion criteria at time of surgery
  • Sufficient bone volume at the implant site for placing a NobelReplace CC implant.
  • Initial implant stability as assessed by hand testing.
  • Defect size for guided bone regeneration:

Height ≥ 3 mm and ≤ 7 mm as assessed with a UNC15 periodontal probe.

Exclusion Criteria:

  • Previous bone augmentation at the implant site.
  • Extraction site less than 3 months after extraction.
  • Soft tissue grafting at implant placement, soft tissue grafting is allowed only at re-entry.
  • Health conditions, which do not permit the surgical treatment.
  • Any disorders in the planned implant area such as previous tumours, chronic bone disease or previous irradiation
  • Infections in the planned implantation site or adjacent tissue.
  • Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
  • Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc).
  • Alcohol or substance abuse as noted in subject records or in subject history.
  • Heavy smoking (>10 cigarettes/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%.
  • Severe bruxism or other destructive habits.
  • Pregnant or lactating women at the time of collagen membrane insertion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02373787
Other Study ID Numbers  ICMJE T 186
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nobel Biocare
Study Sponsor  ICMJE Nobel Biocare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Isabelle Arrighi, PhD Nobel Biocare Services AG
PRS Account Nobel Biocare
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP