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

Edentulous Maxilla Clinical Trial

Official title:

Implant-fixed Restorations With Short Implants in the Edentulous Maxilla - A Clinical Investigation Over a 5-year Follow-up Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656823
• Other study ID #: C-AN-14-001
• Status: Completed
• Phase: N/A
• Start date: November 24, 2015
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2024
• Source: Dentsply Sirona Implants and Consumables
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Maxilla
• Mouth, Edentulous

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Nova Southeastern University	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants and Consumables

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Visit 14, 5 years after permanent restoration (PR).
Secondary	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).	At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP).
Secondary	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.	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).
Secondary	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.	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).
Secondary	Mean Probing Pocket Depth (PPD) at Subject Level.	PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm.	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).
Secondary	At Least One Surface With Plaque.	Plaque was recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site (mesially, distally, buccally and lingually).	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).
Secondary	Any Bleeding on Implant (BoP)	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.	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).
Secondary	Oral Health Impact Profile 14 (OHIP-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.	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).
Secondary	Prosthetic Survival Rate on Subject Level	A prosthetic restoration was considered a survived if the original restoration was still in place, regardless of its condition, at the follow-up visit.	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).