Clinical trial NCT02656823: Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study
Official title: Implant-fixed Restorations With Short Implants in the Edentulous Maxilla - A Clinical Investigation Over a 5-year Follow-up Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Maxilla
Keywords: ANKYLOS
Simplant
maxilla
edentulous
short implants
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.

Detailed description: Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function. The primary objective was to evaluate implant survival.

Eligibility criteria: INCLUSION CRITERIA

For inclusion in the study subjects had to meet all of the following criteria:

1. Aged 18-80 years at inclusion.
2. Signed informed consent.
3. In need of full-arch restoration of the maxilla.

   The following should be considered at inclusion but should be fulfilled at Implant Placement (Visit 3):
4. Maxilla: totally edentulous, fulfilling all of the following criteria:

   1. History of edentulism: ≥ 6 months and,
   2. Minimum bone height: ≥ 7 mm and,
   3. Minimum bone width: ≥ 5.5 mm.
5. Mandible: antagonistic natural dentition or tooth/implant borne rehabilitation which can be used to create a stable occlusal fit with the new full-arch restoration of the upper jaw.

EXCLUSION CRITERIA

Any of the following was regarded as a criterion for exclusion from the study:

1. Unlikely to be able to comply with study procedures according to Investigator's judgement.
2. History of bone augmentation in the maxilla within 6 months prior to surgery.
3. Uncontrolled pathologic processes in the oral cavity.
4. Bruxism.
5. Smoking \>10 cigarettes per day.
6. Present alcohol or drug abuse.
7. History of radiation therapy in head and neck region.
8. History of chemotherapy within 5 years prior to surgery.
9. Condition that would compromise post-operative tissue healing or osseointegration.
10. Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration.
11. Known pregnancy at time of inclusion.
12. Current or former participation in a clinical study that may interfere with the present study.
13. Involvement in the planning and conduct of the study.

Primary outcomes:
measure: Implant Survival Rate
timeFrame: At Visit 14, 5 years after permanent restoration (PR).
Secondary outcomes:
measure: Implant Stability
timeFrame: At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP).
measure: Mean Marginal Bone Level (MBL) at Subject's Tissue Level
timeFrame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
measure: Mean Marginal Bone Level (MBL) on Implant Level.
timeFrame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
measure: Mean Probing Pocket Depth (PPD) at Subject Level.
timeFrame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
measure: At Least One Surface With Plaque.
timeFrame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
measure: Any Bleeding on Implant (BoP)
timeFrame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
measure: Oral Health Impact Profile 14 (OHIP-14)
timeFrame: At pre-surgical planning (Visit 2) on average 6 months before PR, and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
measure: Prosthetic Survival Rate on Subject Level
timeFrame: At 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
affiliation: J. W. Goethe-Universität, Frankfurt
name: Paul Weigl
role: PRINCIPAL_INVESTIGATOR
References: