Jaw, EdentulousPhase 4NCT00922935
Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants
A Phase 4 study testing Cresco and Straumann components in people with Jaw, Edentulous, run by Institut Straumann AG at 2 sites in Sweden.
Trial summary
Comparison of early and late loading of implants supporting full each prosthesis in upper jaw, using the Cresco prosthetic system on Straumann implants. The study hypothesis is that there is no difference between the bone loss (or gain) between the groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- Cresco and Straumann components
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2004to Sep 2009
- 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.
- Be edentulous in the maxilla and subjectively desire an implant supported screw retained FPD
- The teeth at the implant site must have been extracted or lost at least 3 months before the date of implantation.
- In the case of Guided Bone Regeneration(GBR) or Guided Tissue Regeneration (GTR) treatments, these procedures must have been completed at least 6 months prior to intended surgery date (to fulfil point 5).
- Adequate bone quality and quantity at the six, minimum five, implant sites to permit the insertion of Straumann 4.1 and 3.3 mm diameter implants without the use of concurrent bone augmentation techniques. 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 palatal and buccal bone will remain.
- Patients must be committed to participate in the study for three years follow-up examinations
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 radiation or chemotherapy
- Patients with history of renal failure
Show all 26Show fewer
- Patients with metabolic bone disorders
- History of 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 more than 10 cigarettes per day or cigar equivalents, or who chew tobacco (not greater than 10 cigarette equivalents)
- 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, 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 3 months post extraction of teeth in intended sites)
- Bone surgery (bone grafts, guided tissue regeneration technique for bone enhancement) at implant placement.
- Severe bruxing or clenching habits
- Persistent intraoral infection
- Patients with inadequate oral hygiene or unmotivated for adequate home care
- Lack of primary stability of 1 or more implant(s) at surgery. In this instance the patient must be withdrawn and treated accordingly.
- Insufficient bone
- Other: Inability to place implants according to protocol requirements
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
STP Oral protetik
Kalmar, 39185
Oral rehabilitering
Linköping, 58185
About this study
Official title: A 3 Arm Controlled Randomised Study: Comparison of Early and Late Loading Protocols in Full Arch Reconstructions in the Edentulous Maxilla, Using The Cresco Prosthetic System on Straumann Implants
Comparison of early and late loading of implants supporting full each prosthesis in upper jaw, using the Cresco prosthetic system on Straumann implants. The study hypothesis is that there is no difference between the bone loss (or gain) between the groups.
Read the detailed description
The study is a controlled randomised study whereby each patient will receive 5-6 implants placed in the edentulous upper jaw supporting a 10-12 unit screw-retained fixed partial denture (FPD). The main objective of the study is to evaluate the performance of Straumann implants supporting a FPD using Straumann Implants and Cresco restorative components in early and delayed loading protocols at one year post-loading. The treatment groups consist of an early loading and delayed loading arm using Cresco restorative components loading time 10 days post surgery and at 6-8 weeks respectively. The control group comprise the standard delayed loading protocol (healing period 6-8 weeks) and Straumann restorative components. The primary objective is to compare changes in crestal bone levels on radiographs between implants in the control group and test groups at 1 year.The patients will be followed for 3 years.
- Conditions
- Jaw, Edentulous
- Being tested
- Cresco, Straumann components
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrescoDevice
Cresco components loading 10 days post surgery
CrescoDevice
Cresco loading at 6-8 weeks post surgery
Straumann componentsDevice
Straumann components loading 6-8 weeks post surgery
| Study group | Role | What they receive |
|---|---|---|
| Cresco early loading | Experimental | The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery Receives: Device: Cresco |
| Cresco late loading | Experimental | Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before "try ins" to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery. Receives: Device: Cresco |
| Straumann system late loading | Active comparator | Straumann components loading at 6-8 weeks post surgery Receives: Device: Straumann components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Level Change on Radiographs
Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.
Measured: 3 years after loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startOct 2004
- Primary completionFeb 2009
- Study completionSep 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for Jaw, EdentulousStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Ellner, DDS, PhD, Principal investigator, STP Oral protetik, Kalmar, SwedenAsbjorn Jokstad, Professor, Principal investigator, University of Toronto, Faculty of Denistry, 124 Edward Street, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922935
- Sponsor's protocol ID
- CR 02/04
- Status last verified
- Mar 2016
- First submitted
- 16 Jun 2009
- Last updated
- 31 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jokstad A, Ellner S, Gussgard A. Comparison of two early loading protocols in full arch reconstructions in the edentulous maxilla using the Cresco prosthetic system: a three-arm parallel group randomized-controlled trial. Clin Oral Implants Res. 2011 May;22(5):455-63. doi: 10.1111/j.1600-0501.2010.02156.x. Epub 2011 Mar 24.
PubMed 21435016
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3 Arm Controlled Randomised Study: Comparison of Early and Late Loading Protocols in Full Arch Reconstructions in the Edentulous Maxilla, Using The Cresco Prosthetic System on Straumann Implants
- ClinicalTrials.gov ID
- NCT00922935
- Acronym / sponsor ID
- CR 02/04
- Conditions
- Jaw, Edentulous
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Posted 12 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of early and late loading of implants supporting full each prosthesis in upper jaw, using the Cresco prosthetic system on Straumann implants. The study hypothesis is that there is no difference between the bone loss (or gain) between the groups.
Detailed description
The study is a controlled randomised study whereby each patient will receive 5-6 implants placed in the edentulous upper jaw supporting a 10-12 unit screw-retained fixed partial denture (FPD). The main objective of the study is to evaluate the performance of Straumann implants supporting a FPD using Straumann Implants and Cresco restorative components in early and delayed loading protocols at one year post-loading. The treatment groups consist of an early loading and delayed loading arm using Cresco restorative components loading time 10 days post surgery and at 6-8 weeks respectively. The control group comprise the standard delayed loading protocol (healing period 6-8 weeks) and Straumann restorative components. The primary objective is to compare changes in crestal bone levels on radiographs between implants in the control group and test groups at 1 year.The patients will be followed for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cresco early loading | Experimental | Device: CrescoThe implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery |
| Cresco late loading | Experimental | Device: CrescoHealing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before "try ins" to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery. |
| Straumann system late loading | Active comparator | Device: Straumann componentsStraumann components loading at 6-8 weeks post surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females must be at least 18 years of age.
- Be edentulous in the maxilla and subjectively desire an implant supported screw retained FPD
- The teeth at the implant site must have been extracted or lost at least 3 months before the date of implantation.
- In the case of Guided Bone Regeneration(GBR) or Guided Tissue Regeneration (GTR) treatments, these procedures must have been completed at least 6 months prior to intended surgery date (to fulfil point 5).
- Adequate bone quality and quantity at the six, minimum five, implant sites to permit the insertion of Straumann 4.1 and 3.3 mm diameter implants without the use of concurrent bone augmentation techniques. 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 palatal 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 radiation or 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 |
|---|---|---|
| CrescoCresco components loading 10 days post surgery | Device | Cresco early loading |
| CrescoCresco loading at 6-8 weeks post surgery | Device | Cresco late loading |
| Straumann componentsStraumann components loading 6-8 weeks post surgery | Device | Straumann system late loading |
Primary outcome
Bone Level Change on Radiographs
Time frame: 3 years after loading
Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21435016Jokstad A, Ellner S, Gussgard A. Comparison of two early loading protocols in full arch reconstructions in the edentulous maxilla using the Cresco prosthetic system: a three-arm parallel group randomized-controlled trial. Clin Oral Implants Res. 2011 May;22(5):455-63. doi: 10.1111/j.1600-0501.2010.02156.x. Epub 2011 Mar 24.
- 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.
Stefan Ellner, DDS, PhD principal investigator
STP Oral protetik, Kalmar, Sweden
Asbjorn Jokstad, Professor principal investigator
University of Toronto, Faculty of Denistry, 124 Edward Street, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cresco and Straumann components in people with Jaw, Edentulous, run by Institut Straumann AG at 2 sites in Sweden.
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 6 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 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 12 Jul 2011). 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?
Bone Level Change on Radiographs (time frame: 3 years after loading). 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 NCT00922935, which also lists 1 linked publication.
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 31 Mar 2016.