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

NCT ID: NCT02656823

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-24
• Study Completion Date: 2022-12-01

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.

Conditions

Edentulous Maxilla

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ANKYLOS C/X Implant A 6.6

ANKYLOS C/X Implant A 6.6 mm

Group Type: EXPERIMENTAL

ANKYLOS C/X implant A 6.6

Intervention Type: DEVICE

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

Interventions

ANKYLOS C/X implant A 6.6

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Weigl

Role: PRINCIPAL_INVESTIGATOR

J. W. Goethe-Universität, Frankfurt

Locations

Nova Southeastern University

Fort Lauderdale, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

C-AN-14-001

Identifier Type: -

Identifier Source: org_study_id