N/A
N=12
Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study
Edentulous Maxilla
Bottom Line
View on ClinicalTrials.gov: NCT02656823 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Implant Survival Rate — 41; 19 Implants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ANKYLOS C/X implant A 6.6 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survival Rate |
41; 19 | — |
| SECONDARY Implant Stability |
35; 37; 5; 67 | — |
| SECONDARY Mean Marginal Bone Level (MBL) at Subject's Tissue Level |
1.43; 1.44; 1.20; 1.17 | — |
| SECONDARY Mean Marginal Bone Level (MBL) on Implant Level. |
1.41; 1.42; 1.21; 1.17 | — |
| SECONDARY Mean Probing Pocket Depth (PPD) at Subject Level. |
3.4; 3.5; 4.1; 3.4; 3.9; 3.4 | — |
| SECONDARY At Least One Surface With Plaque. |
14; 32; 35; 28; 35; 23 | — |
| SECONDARY Any Bleeding on Implant (BoP) |
24; 44; 39; 29; 29; 15 | — |
| SECONDARY Oral Health Impact Profile 14 (OHIP-14) |
27.8; 5.2; 8.3; 4.5; 6.9 | — |
| SECONDARY Prosthetic Survival Rate on Subject Level |
10; 1; 10; 0; 8; 0 | — |
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.
Eligibility Criteria
INCLUSION CRITERIA
For inclusion in the study subjects had to meet all of the following criteria:
- Aged 18-80 years at inclusion.
- Signed informed consent.
- 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):
- Maxilla: totally edentulous, fulfilling all of the following criteria:
- History of edentulism: ≥ 6 months and,
- Minimum bone height: ≥ 7 mm and,
- Minimum bone width: ≥ 5.5 mm.
- 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:
- Unlikely to be able to comply with study procedures according to Investigator's judgement.
- History of bone augmentation in the maxilla within 6 months prior to surgery.
- Uncontrolled pathologic processes in the oral cavity.
- Bruxism.
- Smoking >10 cigarettes per day.
- Present alcohol or drug abuse.
- History of radiation therapy in head and neck region.
- History of chemotherapy within 5 years prior to surgery.
- Condition that would compromise post-operative tissue healing or osseointegration.
- Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration.
- Known pregnancy at time of inclusion.
- Current or former participation in a clinical study that may interfere with the present study.
- Involvement in the planning and conduct of the study.
Data sourced from ClinicalTrials.gov (NCT02656823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.