NCT02373787

Brief Summary

A 5-year clinical investigation on creos xenoprotect

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

2.6 years

First QC Date

October 20, 2014

Last Update Submit

November 9, 2017

Conditions

Implant

Keywords

ResorbableCollagen membraneNobelReplace CC

Outcome Measures

Primary Outcomes (1)

  • To demonstrate bone regeneration through measurement of defect height

    6 months

Secondary Outcomes (1)

  • Adverse events (AEs)

    6 months

Other Outcomes (2)

  • Membrane Dehiscence

    6 months

  • success and survival rates of implants

    5 years

Study Arms (2)

creos xenoprotect

EXPERIMENTAL

resorbable collagen membrane

Device: creos xenoprotect

Bio-Gide

ACTIVE COMPARATOR

Bio-Gide, resorbable collagen membrane

Device: Bio-Gide

Interventions

creos xenoprotectDEVICE

Implant placement with simultaneous bone augmentation

creos xenoprotect
Bio-GideDEVICE

resorbable collagen membrane

Bio-Gide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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:
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxisklinik der Zahnheilkunde am Luisenhospital

Aachen, 52064, Germany

Location

Study Officials

  • Isabelle Arrighi, PhD

    Nobel Biocare Services AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

February 27, 2015

Study Start

July 1, 2013

Primary Completion

January 28, 2016

Study Completion

October 2, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

DE(1)