Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.

NCT01528215 | Completed Results

• 1 other identifier: OTX-PLUS-0001
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.

Conditions

Partial Edentulism in the Maxilla or in the Mandible

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Level Change After 1 Year in Use.

  Marginal bone level will be determined from radiographs and expressed as 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. Marginal bone level expressed in millimeters at the 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.

  Evaluated at implant loading and at the 1 year follow-up after implant loading.

Secondary Outcomes (1)

• Marginal Bone Level Change After 5 Years in Use.

  Evaluated from implant loading to the 5 years follow-up after implant loading.

Study Arms (2)

OsseoSpeed EV

EXPERIMENTAL

OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm

Device: OsseoSpeed EV

OsseoSpeed TX

ACTIVE COMPARATOR

OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm

Device: OsseoSpeed TX

Interventions

OsseoSpeed EV DEVICE

OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm

OsseoSpeed EV

OsseoSpeed TX DEVICE

OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm

OsseoSpeed TX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of Informed Consent.
• years at enrollment.
• In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
• History of edentulism in the planned implant area of at least 3 months (at Visit 2).
• At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
• Deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants.
• Deemed by the investigator to be suitable for loading after 6-8 weeks.
• Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge.

You may not qualify if:

• Unlikely to be able to comply with study procedures, as judged by the investigator.
• Uncontrolled pathological processes in the oral cavity.
• Untreated, uncontrolled caries and/or periodontal disease.
• Known or suspected current malignancy.
• History of radiation therapy in the head and neck region.
• History of chemotherapy within 5 years prior to surgery.
• Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration, as deemed by the investigator.
• Uncontrolled diabetes mellitus.
• Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration.
• Smoking more than 10 cigarettes per day.
• Present alcohol and/or drug abuse.
• Current need for bone grafting and/or augmentation in the planned implant area. Local, minor soft tissue grafting will be allowed.
• Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site).
• Previous enrollment in the present study.
• Simultaneous participation in other clinical studies at enrollment (Visit 1) and during the subject's first year of this study.

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (4)

Dows Institute for Dental Research, University of Iowa, College of Dentistry

Iowa City, Iowa, 52242-1010, United States

Location

University Hospital Ghent, Dental School Department Periodontology

Ghent, 9000, Belgium

Location

Dep. of Prosthodontics, Goethe University

Frankfurt am Main, 605 90, Germany

Location

Dental private practice, Denis Cecchinato

Padua, 351 25, Italy

Location

Related Publications (1)

• Stanford CM, Barwacz C, Raes S, De Bruyn H, Cecchinato D, Bittner N, Brandt J. Multicenter Clinical Randomized Controlled Trial Evaluation of an Implant System Designed for Enhanced Primary Stability. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):906-15. doi: 10.11607/jomi.4869.

  PMID: 27447160 RESULT

Results Point of Contact

• Title: Manager Global Clinical Affairs
• Organization: DENTSPLY Implants

ClinicalResearchMolndal@dentsplysirona.com

+46313763500

Study Officials

• Clark M Stanford, Prof

  University of Illinois at Chicago, College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: April 1, 2018
• Last Updated: April 22, 2020
• Results First Posted: April 14, 2016

Record last verified: 2020-04

Locations

BE (1); IT (1); DE (1); US (1)