Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
49 participants
INTERVENTIONAL
2013-07-31
2017-10-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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creos xenoprotect
resorbable collagen membrane
creos xenoprotect
Implant placement with simultaneous bone augmentation
Bio-Gide
Bio-Gide, resorbable collagen membrane
Bio-Gide
resorbable collagen membrane
Interventions
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creos xenoprotect
Implant placement with simultaneous bone augmentation
Bio-Gide
resorbable collagen membrane
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
18 Years
ALL
No
Sponsors
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Nobel Biocare
INDUSTRY
Responsible Party
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Principal Investigators
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Isabelle Arrighi, PhD
Role: STUDY_DIRECTOR
Nobel Biocare Services AG
Locations
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Praxisklinik der Zahnheilkunde am Luisenhospital
Aachen, , Germany
Countries
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Other Identifiers
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T 186
Identifier Type: -
Identifier Source: org_study_id