Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study

Dentsply Sirona Implants and Consumables12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Edentulous Maxilla

Interventions

ANKYLOS C/X implant A 6.6DEVICE

Treatment with six (6) 6.6 mm implants and a bridge to restore chewing function of an edentulous maxilla.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nova Southeastern University

Fort Lauderdale, Florida, United States

Outcomes

Primary Outcomes

Implant Survival Rate

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.

Time frame: At Visit 14, 5 years after permanent restoration (PR).

Secondary Outcomes

Implant Stability

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).

Time frame: At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP).

Mean Marginal Bone Level (MBL) at Subject's Tissue Level

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.

Time frame: 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).

Mean Marginal Bone Level (MBL) on Implant Level.

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.

Data from ClinicalTrials.gov

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