NCT02681250

Brief Summary

A Randomized controlled Clinical trial which aim is to investigate the clinical outcome of dental implants in titanium-zirconium alloy compared to traditional titan-4 implants. The hypothesis is set to no difference in the clinical outcome for the two types of implants. Preliminary estimation of 96 patients needed. A pilot study will provide us with further data in order to more accurately specify the sample number."

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

5.8 years

First QC Date

February 1, 2016

Last Update Submit

November 11, 2019

Conditions

Endosseous Dental Implant Failure

Keywords

ZirconiumRandomized Controlled TrialDental ImplantsDental MaterialTitanium

Outcome Measures

Primary Outcomes (1)

  • Change in bone loss measured on X-ray (mm)

    Baseline and 1 year

Secondary Outcomes (4)

  • Change in bleeding on probing (Yes/No)

    Baseline and 1 year

  • Change in amount of Clinical Mucosa (mm)

    Baseline and 1 year

  • Change in Pocket depth (mm)

    Baseline and 1 year

  • Change in Prosthetic Complications (Yes/No)

    Baseline and 1 year

Study Arms (2)

Titanium-zirconium

EXPERIMENTAL

Patients receiving titanium-zirconium implants

Procedure: Titanium-zirconium

Titanium

ACTIVE COMPARATOR

Patients receiving titanium implants

Procedure: Titanium

Interventions

Titanium-zirconiumPROCEDURE

Titanium-zirconium implants will be installed according to the protocol earlier described in the detailed description.

Also known as: Straumann Roxolid SLA
Titanium-zirconium
TitaniumPROCEDURE

Titanium implants will be installed according to the protocol earlier described in the detailed description.

Also known as: Straumann SLA (Sand blasted, Large grit, Acid Etched)
Titanium

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients in need for implant treatment

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Specialisttandvården Borås

Borås, 50282, Sweden

RECRUITING

Related Publications (18)

  • Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available.

    PMID: 4924041BACKGROUND

  • Ekelund JA, Lindquist LW, Carlsson GE, Jemt T. Implant treatment in the edentulous mandible: a prospective study on Branemark system implants over more than 20 years. Int J Prosthodont. 2003 Nov-Dec;16(6):602-8.

    PMID: 14714838BACKGROUND

  • Jemt T. Single implants in the anterior maxilla after 15 years of follow-up: comparison with central implants in the edentulous maxilla. Int J Prosthodont. 2008 Sep-Oct;21(5):400-8.

    PMID: 18950060BACKGROUND

  • Jemt T, Ahlberg G, Henriksson K, Bondevik O. Changes of anterior clinical crown height in patients provided with single-implant restorations after more than 15 years of follow-up. Int J Prosthodont. 2006 Sep-Oct;19(5):455-61.

    PMID: 17323723BACKGROUND

  • Wennerberg A, Albrektsson T, Andersson B. Bone tissue response to commercially pure titanium implants blasted with fine and coarse particles of aluminum oxide. Int J Oral Maxillofac Implants. 1996 Jan-Feb;11(1):38-45.

    PMID: 8820121BACKGROUND

  • Wennerberg A, Albrektsson T, Johansson C, Andersson B. Experimental study of turned and grit-blasted screw-shaped implants with special emphasis on effects of blasting material and surface topography. Biomaterials. 1996 Jan;17(1):15-22. doi: 10.1016/0142-9612(96)80750-2.

    PMID: 8962942BACKGROUND

  • Wennerberg A, Albrektsson T, Lausmaa J. Torque and histomorphometric evaluation of c.p. titanium screws blasted with 25- and 75-microns-sized particles of Al2O3. J Biomed Mater Res. 1996 Feb;30(2):251-60. doi: 10.1002/(SICI)1097-4636(199602)30:23.0.CO;2-P.

    PMID: 9019491BACKGROUND

  • Berglundh T, Abrahamsson I, Lang NP, Lindhe J. De novo alveolar bone formation adjacent to endosseous implants. Clin Oral Implants Res. 2003 Jun;14(3):251-62. doi: 10.1034/j.1600-0501.2003.00972.x.

    PMID: 12755774BACKGROUND

  • Bougas K, Jimbo R, Vandeweghe S, Hayashi M, Bryington M, Kozai Y, Schwartz-Filho HO, Tovar N, Adolfsson E, Ono D, Coelho PG, Wennerberg A. Bone apposition to laminin-1 coated implants: histologic and 3D evaluation. Int J Oral Maxillofac Surg. 2013 May;42(5):677-82. doi: 10.1016/j.ijom.2012.11.008. Epub 2012 Dec 8.

    PMID: 23228694BACKGROUND

  • Kobayashi E, Matsumoto S, Doi H, Yoneyama T, Hamanaka H. Mechanical properties of the binary titanium-zirconium alloys and their potential for biomedical materials. J Biomed Mater Res. 1995 Aug;29(8):943-50. doi: 10.1002/jbm.820290805.

    PMID: 7593037BACKGROUND

  • Gottlow J, Dard M, Kjellson F, Obrecht M, Sennerby L. Evaluation of a new titanium-zirconium dental implant: a biomechanical and histological comparative study in the mini pig. Clin Implant Dent Relat Res. 2012 Aug;14(4):538-45. doi: 10.1111/j.1708-8208.2010.00289.x. Epub 2010 Jun 25.

    PMID: 20586785BACKGROUND

  • Wen B, Zhu F, Li Z, Zhang P, Lin X, Dard M. The osseointegration behavior of titanium-zirconium implants in ovariectomized rabbits. Clin Oral Implants Res. 2014 Jul;25(7):819-25. doi: 10.1111/clr.12141. Epub 2013 Feb 21.

    PMID: 23432001BACKGROUND

  • Barter S, Stone P, Bragger U. A pilot study to evaluate the success and survival rate of titanium-zirconium implants in partially edentulous patients: results after 24 months of follow-up. Clin Oral Implants Res. 2012 Jul;23(7):873-81. doi: 10.1111/j.1600-0501.2011.02231.x. Epub 2011 Jun 24.

    PMID: 21707752BACKGROUND

  • Benic GI, Gallucci GO, Mokti M, Hammerle CH, Weber HP, Jung RE. Titanium-zirconium narrow-diameter versus titanium regular-diameter implants for anterior and premolar single crowns: 1-year results of a randomized controlled clinical study. J Clin Periodontol. 2013 Nov;40(11):1052-61. doi: 10.1111/jcpe.12156. Epub 2013 Sep 8.

    PMID: 24015975BACKGROUND

  • 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: 22171722BACKGROUND

  • Chrcanovic BR, Albrektsson T, Wennerberg A. Smoking and dental implants: A systematic review and meta-analysis. J Dent. 2015 May;43(5):487-98. doi: 10.1016/j.jdent.2015.03.003. Epub 2015 Mar 14.

    PMID: 25778741BACKGROUND

  • Weber HP, Buser D, Fiorellini JP, Williams RC. Radiographic evaluation of crestal bone levels adjacent to nonsubmerged titanium implants. Clin Oral Implants Res. 1992 Dec;3(4):181-8. doi: 10.1034/j.1600-0501.1992.030405.x.

    PMID: 1298433BACKGROUND

  • Hermann JS, Cochran DL, Nummikoski PV, Buser D. Crestal bone changes around titanium implants. A radiographic evaluation of unloaded nonsubmerged and submerged implants in the canine mandible. J Periodontol. 1997 Nov;68(11):1117-30. doi: 10.1902/jop.1997.68.11.1117.

    PMID: 9407406BACKGROUND

MeSH Terms

Interventions

titanium alloy (TiNb13Zr13)Titanium

Intervention Hierarchy (Ancestors)

Metals, LightElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Kostas Bougas, PhD

    Borås Regional Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Hultin, Dentist

CONTACT

010-4419590kristina.e.hultin@vgregion.se

Kostas Bougas, PhD

CONTACT

010-4419590kostas.bougas@vgregion.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 12, 2016

Study Start

February 1, 2015

Primary Completion

December 1, 2020

Study Completion

July 1, 2021

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)