NCT01030523

Brief Summary

The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) in combination with bone grafting. The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
5 countries

5 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

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

September 7, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2022

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

7.2 years

First QC Date

December 10, 2009

Results QC Date

August 20, 2020

Last Update Submit

March 9, 2023

Conditions

Jaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (1)

  • Implant Survival Rate

    Any implant that is removed after implant placement will be considered a failure, whatever the reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants. Implant survival rate will be calculated by dividing the number of non-failures by the number of installed implant.

    5 years after permanent restoration

Secondary Outcomes (8)

  • Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level

    Time of permanent restoration and 5 years after permanent restoration

  • Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level

    Time of permanent restoration and 10 years after permanent restoration

  • Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)

    5 years after permanent restoration

  • Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)

    10 years after permanent restoration

  • Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration

    Time of permanent restoration and 5 years after permanent restoration

  • +3 more secondary outcomes

Study Arms (2)

Short Implants

EXPERIMENTAL

ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)

Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)

Long Implants in combination with bone grafting

ACTIVE COMPARATOR

ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting

Device: ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting

Interventions

ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)DEVICE

ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)

Short Implants
ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone graftingDEVICE

ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting

Long Implants in combination with bone grafting

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent
  • Aged 20-75 years at enrolment
  • History of edentulism in the study area of at least four months
  • In need for 1-4 implants in either side of the posterior maxilla (premolar and molar region)
  • Neighboring tooth/teeth to the planned implant/s must have natural root(s) or implant supported restoration, with absence of pathology or excessive bone loss, as judged by the investigator
  • Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s
  • Deemed by the investigator to have a bone height between 5 and 7 mm and a bone width of a minimum of 6 mm
  • Deemed by the investigator as likely to present an initially stable implant situation

You may not qualify if:

  • Unlikely to be able to comply with study procedures, as judged by the investigator
  • Earlier bone graft procedures in the study area
  • Uncontrolled pathologic processes in the oral cavity
  • 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 could compromise post-operative healing and/or osseointegration
  • Uncontrolled diabetes mellitus
  • Corticosteroids, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration
  • Smoking more than 10 cigarettes/day
  • Bruxism
  • Present alcohol and/or drug abuse
  • Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
  • Previous enrolment in the present study
  • Simultaneous participation in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Oral Rehabilitation, Skeletal Development and Biomaterials, University of Connecticut, School of Dental Medicine

Farmington, Connecticut, 06030, United States

Location

Ärztegesellschaft für Zahn- Mund- und Kieferheilkunde, Akademie für Orale Implantologie: Fürhauser, Haas, Mailath-Pokorny & Watzek OG

Vienna, A-1090, Austria

Location

Aesthetic Dent

Szczecin, P-71-403, Poland

Location

Facultad de Medicina y Odontologia, Universidade de Santiago de Compostela

Santiago de Compostela, ES-15782, Spain

Location

Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich

Zurich, CH-8032, Switzerland

Location

Related Publications (5)

  • Thoma DS, Haas R, Tutak M, Garcia A, Schincaglia GP, Hammerle CH. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 1: demographics and patient-reported outcomes at 1 year of loading. J Clin Periodontol. 2015 Jan;42(1):72-80. doi: 10.1111/jcpe.12323. Epub 2014 Dec 26.

    PMID: 25418606RESULT

  • Schincaglia GP, Thoma DS, Haas R, Tutak M, Garcia A, Taylor TD, Hammerle CH. Randomized controlled multicenter study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 2: clinical and radiographic outcomes at 1 year of loading. J Clin Periodontol. 2015 Nov;42(11):1042-51. doi: 10.1111/jcpe.12465. Epub 2015 Nov 27.

    PMID: 26425812RESULT

  • Pohl V, Thoma DS, Sporniak-Tutak K, Garcia-Garcia A, Taylor TD, Haas R, Hammerle CH. Short dental implants (6 mm) versus long dental implants (11-15 mm) in combination with sinus floor elevation procedures: 3-year results from a multicentre, randomized, controlled clinical trial. J Clin Periodontol. 2017 Apr;44(4):438-445. doi: 10.1111/jcpe.12694. Epub 2017 Mar 6.

    PMID: 28081288RESULT

  • Thoma DS, Haas R, Sporniak-Tutak K, Garcia A, Taylor TD, Hammerle CHF. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 5-Year data. J Clin Periodontol. 2018 Dec;45(12):1465-1474. doi: 10.1111/jcpe.13025. Epub 2018 Nov 25.

    PMID: 30341961RESULT

  • Thoma DS, Haas R, Sporniak-Tutak K, Garcia A, Taylor TD, Tutak M, Pohl V, Hammerle CHF. Randomized controlled multi-centre study comparing shorter dental implants (6 mm) to longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 10-year data. J Clin Periodontol. 2024 Apr;51(4):499-509. doi: 10.1111/jcpe.13954. Epub 2024 Jan 31.

    PMID: 38296249DERIVED

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Results Point of Contact

Title
Manager of Global Clinical Research
Organization
Dentsply Sirona Implants
ClinicalResearchMolndal@dentsplysirona.com
+46313763500

Study Officials

  • Christoph Hämmerle, Prof. Dr.

    Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

December 10, 2009

First Posted

December 11, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2016

Study Completion

March 22, 2022

Last Updated

April 6, 2023

Results First Posted

September 7, 2020

Record last verified: 2023-03

Locations

ES(1)AU(1)PL(1)US(1)CH(1)