NCT00782171

Brief Summary

The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_4

Geographic Reach
9 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

June 20, 2017

Completed
Last Updated

June 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

October 28, 2008

Results QC Date

March 3, 2016

Last Update Submit

April 6, 2017

Conditions

Partial Edentulism

Keywords

Dental implants

Outcome Measures

Primary Outcomes (4)

  • Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.

    Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery

  • Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.

    Change in crestal bone level from surgery (baseline) to 1 year post-surgery

  • Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.

    Change in crestal bone level from surgery (baseline) to 2 years post-surgery

  • Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.

    Change in crestal bone level from surgery (baseline) to 3 years post-surgery

Secondary Outcomes (10)

  • Implant Survival

    20-23 Weeks post-surgery

  • Implant Survival

    1 year post-surgery

  • Implant Survival

    2 years post-surgery

  • Implant Survival

    3 years post-surgery

  • Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected

    until the 3 year post-surgery

  • +5 more secondary outcomes

Study Arms (2)

Immediate Loading

ACTIVE COMPARATOR

SLActive dental implant(s) will be restored with a temporary restoration on the day of surgery.

Device: SLActive dental implant

Early Loading

ACTIVE COMPARATOR

Healing caps will be placed on the SLActive dental implant(s) immediately after surgery. A provisional restoration will be placed between day 28 to day 34 post surgery

Device: SLActive dental implant

Interventions

SLActive dental implantDEVICE

Straumann® SLActive implants will be placed. Implants in Arm 1 will be restored with a temporary restoration on the day of surgery. Implants in Arm 2 will receive healing caps immediately after surgery and a provisional restoration will be placed between day 28 to day 34 post-surgery. In both arms, the final restoration will be placed between 140 and 160 days (20 to 23 weeks) post-surgery.

Also known as: SLActive
Early LoadingImmediate Loading

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females must be at least 18 years of age
  • Have at least one missing tooth in positions FDI 4, 5, 6, or 7 in any quadrant (ADA positions 2, 3, 4, 5; or 12, 13, 14, 15; or 20, 21, 22, 23; or 28, 29, 30, 31.)
  • Subjects desire an implant supported restoration on1 to 4 implants per quadrant
  • The tooth/teeth position(s) at the proposed implant site must have been extracted or lost at least 4 months before the date of implantation and be fully healed
  • Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann standard 4.1 mm diameter implant of at least 8 mm length without the use of concurrent bone augmentation techniques. If more bone is available and is indicated a Straumann standard 4.8 mm diameter implant with a wide neck of at least 8 mm length may be used, i.e. implant insertion sites must have sufficient bone height such that the implant will not encroach on vital structures and sufficient width that a minimum of 1 mm of bone lingual and buccal bone will remain
  • The opposing dentition must be natural teeth or fixed crowns or bridges on natural teeth or implants. Removable prostheses or dentures opposing the study implants are not allowed
  • Patients must be committed to the study for its full duration.

You may not qualify if:

  • Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
  • Medical conditions requiring prolonged use of steroids
  • History of leukocyte dysfunction and deficiencies
  • History of bleeding disorders
  • History of neoplastic disease requiring the use of chemotherapy
  • History of radiation therapy to the head and neck
  • Patients with history of renal failure
  • Patients with severe or uncontrolled metabolic bone disorders
  • Uncontrolled endocrine disorders
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0
  • Alcoholism or drug abuse
  • Patients infected with HIV
  • Patients who smoke \>10 cigarettes per day or cigar equivalents, or who chew tobacco
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Private Practice

Boca Raton, Florida, 33431, United States

Location

Private Practice

Indianapolis, Indiana, 46280, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Tiroler Landeskrankenanstaltengesellschaft mbH

Innsbruck, Austria

Location

Praxisklinik fur Mund- Keifer- und Gesichtschirurgie

Bochum, Germany

Location

Private Practice

Fürth, Germany

Location

Klinikum Nord-Heidberg

Hamburg, Germany

Location

Private Practice

Weiden, Germany

Location

Private Universitat Witten

Witten, Germany

Location

Queens University

Belfast, Ireland

Location

Dublin Dental Hospital

Dublin, Ireland

Location

Rijnland Hospital

Leiderdorp, Netherlands

Location

Faculdade de medicina de coimbra

Coimbra, Portugal

Location

Private Practice

Porto, Portugal

Location

Private Practice

Barcelona, Spain

Location

Private Practice

Málaga, Spain

Location

Clinica Periobalear

Palma de Mallorca, Spain

Location

Private Practice

Falun, Sweden

Location

Private Practice

Sankt Gallen, Switzerland

Location

Related Publications (3)

  • Zollner A, Ganeles J, Korostoff J, Guerra F, Krafft T, Bragger U. Immediate and early non-occlusal loading of Straumann implants with a chemically modified surface (SLActive) in the posterior mandible and maxilla: interim results from a prospective multicenter randomized-controlled study. Clin Oral Implants Res. 2008 May;19(5):442-50. doi: 10.1111/j.1600-0501.2007.01517.x.

    PMID: 18416725RESULT

  • Ganeles J, Zollner A, Jackowski J, ten Bruggenkate C, Beagle J, Guerra F. Immediate and early loading of Straumann implants with a chemically modified surface (SLActive) in the posterior mandible and maxilla: 1-year results from a prospective multicenter study. Clin Oral Implants Res. 2008 Nov;19(11):1119-28. doi: 10.1111/j.1600-0501.2008.01626.x.

    PMID: 18983314RESULT

  • Nicolau P, Korostoff J, Ganeles J, Jackowski J, Krafft T, Neves M, Divi J, Rasse M, Guerra F, Fischer K. Immediate and early loading of chemically modified implants in posterior jaws: 3-year results from a prospective randomized multicenter study. Clin Implant Dent Relat Res. 2013 Aug;15(4):600-12. doi: 10.1111/j.1708-8208.2011.00418.x. Epub 2011 Dec 15.

    PMID: 22171722RESULT

Results Point of Contact

Title
Institut Straumann AG
Organization
Institut Straumann AG - Clinical Research
research@straumann.com
+41 61 965 11 11

Study Officials

  • Axel Zöllner, DDS

    Private Universität Witten/ Herdecke

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 31, 2008

Study Start

July 1, 2004

Primary Completion

October 1, 2006

Study Completion

February 1, 2010

Last Updated

June 20, 2017

Results First Posted

June 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)DE(5)SE(1)PT(2)NL(1)US(3)IE(2)ES(3)CH(1)