A 5 Year Clinical Investigation on Creos Xenoprotect

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

Detailed Description
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Randomized, prospective, multi-center study evaluating creos xenoprotect versus Bio-Gide® for guided bone regeneration in dehiscence defects

Official Title
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A 5 Year Clinical Investigation on Creos Xenoprotect

Conditions
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Implant

Intervention / Treatment
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* Device: creos xenoprotect
* Device: Bio-Gide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: creos xenoprotect<br>resorbable collagen membrane | Device: creos xenoprotect<br>* Implant placement with simultaneous bone augmentation<br>|
| Active Comparator: Bio-Gide<br>Bio-Gide, resorbable collagen membrane | Device: Bio-Gide<br>* resorbable collagen membrane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate bone regeneration through measurement of defect height |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resorbable, Collagen membrane, NobelReplace CC