A 5 Year Clinical Investigation on Creos Xenoprotect (CXP)

A 5-year clinical investigation on creos xenoprotect

Study Overview

• Status: Terminated
• Conditions: Implant
• Intervention / Treatment: Device: creos xenoprotect; Device: Bio-Gide

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52064
    • Praxisklinik der Zahnheilkunde am Luisenhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs)	6 months

Other Outcome Measures

Outcome Measure	Time Frame
Membrane Dehiscence	6 months
success and survival rates of implants	5 years

Collaborators and Investigators

• Sponsor: Nobel Biocare
• Investigators: Study Director: Isabelle Arrighi, PhD, Nobel Biocare Services AG

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): January 28, 2016
• Study Completion (Actual): October 2, 2017

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Collagen membrane; Resorbable; NobelReplace CC
• Other Study ID Numbers: T 186