Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study
- Conditions
- Edentulous Maxilla
- Interventions
- Device: ANKYLOS C/X implant A 6.6
- Registration Number
- NCT02656823
- Lead Sponsor
- Dentsply Sirona Implants and Consumables
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ANKYLOS C/X Implant A 6.6 ANKYLOS C/X implant A 6.6 ANKYLOS C/X Implant A 6.6 mm
- Primary Outcome Measures
Name Time Method Implant Survival Rate At Visit 14, 5 years after permanent restoration (PR). Any implant that is removed after implant placement will be considered failure, whatever reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants.
- Secondary Outcome Measures
Name Time Method At Least One Surface With Plaque. 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). Plaque was recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site (mesially, distally, buccally and lingually).
Oral Health Impact Profile 14 (OHIP-14) 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). Patient satisfaction was evaluated using the Oral Health Impact Profile 14 (OHIP-14). The questionnaire was filled in by the subjects before and after treatment with implants. OHIP-14 includes seven domains: functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. An example of an OHIP statement is "Have you had to interrupt meals because of problems with your teeth, mouth or dentures". Responses are based on a Likert scale (i.e., 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The lowest possible total score (all question responses summed) of the OHIP-4 questionnaire is 0, and the highest possible score is 56. A high score is linked to a poor outcome.
Mean Marginal Bone Level (MBL) at Subject's Tissue Level 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). The mean Marginal Bone Level (MBL) on subject level. Bone level response will be evaluated from intra-oral radiographs. The radiographs will be sent for central evaluation to a radiologist who is independent from the investigational group and the Sponsor. The radiologist will measure and record the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. The reference point is defined as the implant shoulder.
Any Bleeding on Implant (BoP) 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). BoP was evaluated at each of the four surfaces around the implant site (mesially, distally, buccally and lingually), by using a periodontal probe. BoP was recorded as presence or absence of bleeding when probing to the bottom of the pocket.
Implant Stability At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP). Implant stability was evaluated clinically/manually by the investigator at implant placement visit (this initial manual check is called primary stability), and again at the abutment surgery visit. The stability evaluation was recorded as yes/no, yes = judged by the investigator to be stable, or no = judged by the investigator to be unstable. Stability was assessed at implant placement (IP) (Visit 3), and at Abutment Surgery and Impression (Visit 5, at 13 weeks after IP).
Mean Probing Pocket Depth (PPD) at Subject Level. 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). PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm.
Prosthetic Survival Rate on Subject Level 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). A prosthetic restoration was considered a survived if the original restoration was still in place, regardless of its condition, at the follow-up visit.
Mean Marginal Bone Level (MBL) on Implant Level. 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). The mean Marginal Bone Level (MBL) on implant level. Bone level response will be evaluated from intra-oral radiographs. The radiographs will be sent for central evaluation to a radiologist who is independent from the investigational group and the Sponsor. The radiologist will measure and record the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. The reference point is defined as the implant shoulder.
Trial Locations
- Locations (1)
Nova Southeastern University
šŗšøFort Lauderdale, Florida, United States