Clinical trial NCT02373787: A 5 Year Clinical Investigation on Creos Xenoprotect
Official title: A 5 Year Clinical Investigation on Creos Xenoprotect
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Implant
Keywords: Resorbable
Collagen membrane
NobelReplace CC
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2015-02-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: To demonstrate bone regeneration through measurement of defect height
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: 6 months
Other outcomes:
measure: Membrane Dehiscence
timeFrame: 6 months
measure: success and survival rates of implants
timeFrame: 5 years
Locations:
city: Aachen
country: Germany
facility: Praxisklinik der Zahnheilkunde am Luisenhospital
Study officials:
affiliation: Nobel Biocare Services AG
name: Isabelle Arrighi, PhD
role: STUDY_DIRECTOR
References: