Short Implants - An Alternative to Bone Grafting?

Study on ASTRA TECH Implant System, Short Implants (OsseoSpeed™) Compared to Standard Length Implants (OsseoSpeed™) in Combination With Bone Grafting

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.

Study Overview

• Status: Completed
• Conditions: Jaw, Edentulous, Partially
• Intervention / Treatment: Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm); Device: ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, A-1090
    • Ärztegesellschaft für Zahn- Mund- und Kieferheilkunde, Akademie für Orale Implantologie: Fürhauser, Haas, Mailath-Pokorny & Watzek OG
• Poland
  • Szczecin, Poland, P-71-403
    • Aesthetic Dent
• Spain
  • Santiago de Compostela, Spain, ES-15782
    • Facultad de Medicina y Odontologia, Universidade de Santiago de Compostela
• Switzerland
  • Zürich, Switzerland, CH-8032
    • Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich
• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Department of Oral Rehabilitation, Skeletal Development and Biomaterials, University of Connecticut, School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short Implants; ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)	Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm); ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
Active Comparator: Long Implants in combination with bone grafting; 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; ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level	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 millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone.	Time of permanent restoration and 5 years after permanent restoration
Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)	Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level.	5 years after permanent restoration
Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration	PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth.	Time of permanent restoration and 5 years after permanent restoration
Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level	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 millimetres at the 10 year follow-up visit will be compared to values obtained for the 10-years cohort at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone.	Time of permanent restoration and 10 years after permanent restoration
Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)	Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level for the 10-years extension cohort.	10 years after permanent restoration
Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration	PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 10 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth.	Time of permanent restoration and 10 years after permanent restoration
Change in Overall Oral Health Impact Profile (OHIP-49)	OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome.	At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restoration
Change in Overall Oral Health Impact Profile (OHIP-49)	OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome.	At baseline (Visit 1 - screening and pre-surgical planning visit) and 10 years after permanent restoration

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Christoph Hämmerle, Prof. Dr., Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: December 10, 2009
• First Submitted That Met QC Criteria: December 10, 2009
• First Posted (Estimate): December 11, 2009

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: YA-SHO-0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No