Partial EdentulismPhase 4NCT00782171
Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface
A Phase 4 study testing SLActive dental implant in people with Partial Edentulism, run by Institut Straumann AG at 19 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- SLActive dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 19 sitesin 9 countries
- Study dates
- Jul 2004to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
- Local inflammation, including untreated periodontitis
- Mucosal diseases such as erosive lichen planus
- History of local irradiation therapy
- Presence of osseous lesions
- Unhealed extraction sites (less than 4 months post extraction of teeth in intended sites)
- Bone surgery (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement and the site fully healed. Note: Minor bone enhancement using harvested bone from the implant site and a resorbable membrane is allowed at the time of implant placement
- Patients requiring bone grafting at the surgical sites at the time of surgery.
- Severe bruxing or clenching habits
- Persistent intraoral infection
- Lack of primary stability of one (or more) implant(s) at surgery. In this instance the patient must be withdrawn and the patient treated accordingly
- Patients with inadequate oral hygiene or unmotivated for adequate home care
Trial locations and contacts
19 sites in 9 countries.
19 sites in 9 countries
Germany5 sites
Praxisklinik fur Mund- Keifer- und Gesichtschirurgie
Bochum
Private Practice
Fürth
Klinikum Nord-Heidberg
Hamburg
Private Practice
Weiden
Private Universitat Witten
Witten
United States3 sites
Private Practice
Boca Raton, Florida, 33431
Private Practice
Indianapolis, Indiana, 46280
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Spain3 sites
Private Practice
Barcelona
Private Practice
Málaga
Clinica Periobalear
Palma de Mallorca
Portugal2 sites
Faculdade de medicina de coimbra
Coimbra
Private Practice
Porto
About this study
Official title: Immediate and Delayed Loading of 4.1 mm and 4.8 mm Implants in the Posterior Mandible & Maxilla: A Controlled Randomized Study of Single or 2-4 Unit Restorations Loaded Immediately After Surgery or Four Weeks After Surgery
The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.
Read the detailed description
This study is a post-market randomized study whereby each patient will receive 1 to 4 implants placed in the posterior maxilla or mandible. The primary objective of this randomized open study is to evaluate the performance in immediate and delayed loading (4 weeks) of Straumann standard solid screw 4.1mm and the 4.8 mm diameter wide neck implants with a new surface. These implants will support single crowns or 2 to 4 unit bridge restorations in the posterior maxilla or mandible and the treatment will be evaluated for the immediate and delayed loading procedures at one year post surgery. Patients will be allocated into two groups and then randomized into immediate or delayed loading arms.
- Conditions
- Partial Edentulism
- Being tested
- SLActive dental implant
- Keywords
- Dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLActive dental implantDevice
Also called SLActive
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Loading | Active comparator | SLActive dental implant(s) will be restored with a temporary restoration on the day of surgery. Receives: 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 Receives: Device: SLActive dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in crestal bone level from surgery (baseline) to 3 years post-surgery
Secondary outcomes (10)
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation
Measured: 20-23 Weeks post-surgery
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Measured: 1 year post-surgery
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Measured: 2 years post-surgery
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Measured: 3 years post-surgery
Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected
Patients affected by AE Patients affected by related/ unknown AE
Measured: until the 3 year post-surgery
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Measured: 20-23 weeks post-surgery
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Measured: 1 years post-surgery
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Measured: 2 years post-surgery
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Measured: 3 years post-surgery
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events
Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)
Measured: until the 3 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJul 2004
- Primary completionOct 2006
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Zöllner, DDS, Principal investigator, Private Universität Witten/ Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782171
- Sponsor's protocol ID
- CR 06/03
- Status last verified
- Apr 2017
- First submitted
- 28 Oct 2008
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18416725Ganeles 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.
PubMed 18983314Nicolau 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.
PubMed 22171722
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Delayed Loading of 4.1 mm and 4.8 mm Implants in the Posterior Mandible & Maxilla: A Controlled Randomized Study of Single or 2-4 Unit Restorations Loaded Immediately After Surgery or Four Weeks After Surgery
- ClinicalTrials.gov ID
- NCT00782171
- Acronym / sponsor ID
- CR 06/03
- Conditions
- Partial Edentulism
- Keywords
- Dental implants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.
Detailed description
This study is a post-market randomized study whereby each patient will receive 1 to 4 implants placed in the posterior maxilla or mandible. The primary objective of this randomized open study is to evaluate the performance in immediate and delayed loading (4 weeks) of Straumann standard solid screw 4.1mm and the 4.8 mm diameter wide neck implants with a new surface. These implants will support single crowns or 2 to 4 unit bridge restorations in the posterior maxilla or mandible and the treatment will be evaluated for the immediate and delayed loading procedures at one year post surgery. Patients will be allocated into two groups and then randomized into immediate or delayed loading arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Loading | Active comparator | Device: SLActive dental implantSLActive dental implant(s) will be restored with a temporary restoration on the day of surgery. |
| Early Loading | Active comparator | Device: SLActive dental implantHealing 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLActive dental implantAlso: SLActiveStraumann® 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. | Device | Early Loading, Immediate Loading |
Primary outcome
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change in crestal bone level from surgery (baseline) to 3 years post-surgery
10 secondary outcomes
Implant Survival
Time frame: 20-23 Weeks post-surgery
Implant Survival
Time frame: 1 year post-surgery
Implant Survival
Time frame: 2 years post-surgery
Implant Survival
Time frame: 3 years post-surgery
Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected
Time frame: until the 3 year post-surgery
Implant Success
Time frame: 20-23 weeks post-surgery
Implant Success
Time frame: 1 years post-surgery
Implant Success
Time frame: 2 years post-surgery
Implant Success
Time frame: 3 years post-surgery
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events
Time frame: until the 3 year post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18416725Zollner 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.
- Results publication: PubMed 18983314Ganeles 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.
- Results publication: PubMed 22171722Nicolau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Zöllner, DDS principal investigator
Private Universität Witten/ Herdecke
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SLActive dental implant in people with Partial Edentulism, run by Institut Straumann AG at 19 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, United States, Spain, Ireland, Portugal and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. (time frame: Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00782171, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.