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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Implant | Device: creos xenoprotect Device: Bio-Gide | Not Applicable |
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 |
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 |
- To demonstrate bone regeneration through measurement of defect height [ Time Frame: 6 months ]
- Adverse events (AEs) [ Time Frame: 6 months ]
- Membrane Dehiscence [ Time Frame: 6 months ]
- success and survival rates of implants [ Time Frame: 5 years ]

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

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
Germany | |
Praxisklinik der Zahnheilkunde am Luisenhospital | |
Aachen, Germany, 52064 |
Study Director: | Isabelle Arrighi, PhD | Nobel Biocare Services AG |
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 |
Resorbable Collagen membrane NobelReplace CC |