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

NCT02656823 | Completed Results

• 1 other identifier: C-AN-14-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Maxilla

Keywords

ANKYLOS; Simplant; maxilla; edentulous; short implants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Implant Stability

  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

  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.

  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 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).

• 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).

Study Arms (1)

ANKYLOS C/X Implant A 6.6

EXPERIMENTAL

ANKYLOS C/X Implant A 6.6 mm

Device: ANKYLOS C/X implant A 6.6

Interventions

ANKYLOS C/X implant A 6.6 DEVICE

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

ANKYLOS C/X Implant A 6.6

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• In need of full-arch restoration of the maxilla.
• 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.

You may not qualify if:

• 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.
• Current or former participation in a clinical study that may interfere with the present study.
• Involvement in the planning and conduct of the study.

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Results Point of Contact

• Title: Ulrika Bonander
• Organization: DENTSPLY IH AB,

ulrika.bonander@dentsplysirona.com

31 376 30 68

Study Officials

• Paul Weigl

  J. W. Goethe-Universität, Frankfurt

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: January 15, 2016
• Study Start: November 24, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-02

Locations

US (1)