Clinical trial NCT01030523: Short Implants - An Alternative to Bone Grafting?
Official title: Study on ASTRA TECH Implant System, Short Implants (OsseoSpeed™) Compared to Standard Length Implants (OsseoSpeed™) in Combination With Bone Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study was designed as an open, prospective, randomized, controlled, multicenter, 5-year follow-up investigation evaluating the outcome of treatment with the OsseoSpeed™ implant 6 mm placed in the posterior maxilla compared to treatment with OsseoSpeed™ implant 11, 13 or 15 mm placed after bone grafting. The study was during the conduct of the study amended to include a 10-year extension cohort.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Implant Survival Rate
timeFrame: 5 years after permanent restoration
Secondary outcomes:
measure: Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level
timeFrame: Time of permanent restoration and 5 years after permanent restoration
measure: Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level
timeFrame: Time of permanent restoration and 10 years after permanent restoration
measure: Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)
timeFrame: 5 years after permanent restoration
measure: Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)
timeFrame: 10 years after permanent restoration
measure: Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
timeFrame: Time of permanent restoration and 5 years after permanent restoration
measure: Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
timeFrame: Time of permanent restoration and 10 years after permanent restoration
measure: Change in Overall Oral Health Impact Profile (OHIP-49)
timeFrame: At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restoration
measure: Change in Overall Oral Health Impact Profile (OHIP-49)
timeFrame: At baseline (Visit 1 - screening and pre-surgical planning visit) and 10 years after permanent restoration
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Department of Oral Rehabilitation, Skeletal Development and Biomaterials, University of Connecticut, School of Dental Medicine
state: Connecticut
city: Wien
country: Austria
facility: Ärztegesellschaft für Zahn- Mund- und Kieferheilkunde, Akademie für Orale Implantologie: Fürhauser, Haas, Mailath-Pokorny & Watzek OG
city: Szczecin
country: Poland
facility: Aesthetic Dent
city: Santiago de Compostela
country: Spain
facility: Facultad de Medicina y Odontologia, Universidade de Santiago de Compostela
city: Zürich
country: Switzerland
facility: Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich
Study officials:
affiliation: Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich
name: Christoph Hämmerle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.