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A 5 Year Clinical Investigation on Creos Xenoprotect (CXP)

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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

Study Description
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Brief Summary:
A 5-year clinical investigation on creos xenoprotect

Condition or disease Intervention/treatment Phase
Implant Device: creos xenoprotect Device: Bio-Gide Not Applicable

Detailed Description:
Randomized, prospective, multi-center study evaluating creos xenoprotect versus Bio-Gide® for guided bone regeneration in dehiscence defects
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 5 Year Clinical Investigation on Creos Xenoprotect
Study Start Date : July 2013
Actual Primary Completion Date : January 28, 2016
Actual Study Completion Date : October 2, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: creos xenoprotect
resorbable collagen membrane
 Device: creos xenoprotect
Implant placement with simultaneous bone augmentation
Active Comparator: Bio-Gide
Bio-Gide, resorbable collagen membrane
 Device: Bio-Gide
resorbable collagen membrane


Outcome Measures
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Primary Outcome Measures :
  1. To demonstrate bone regeneration through measurement of defect height [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Membrane Dehiscence [ Time Frame: 6 months ]
  2. success and survival rates of implants [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT02373787


Locations
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Germany
Praxisklinik der Zahnheilkunde am Luisenhospital
Aachen, Germany, 52064
Sponsors and Collaborators
Nobel Biocare
Investigators
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Study Director: Isabelle Arrighi, PhD Nobel Biocare Services AG
More Information
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Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT02373787    
Other Study ID Numbers: T 186
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Keywords provided by Nobel Biocare:
Resorbable
Collagen membrane
NobelReplace CC