Jaw, EdentulousNCT01878331
Long-term Study to Evaluate Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants
An observational study of Jaw, Edentulous, run by Institut Straumann AG at 1 site in Switzerland.
Trial summary
Patients with an edentulous mandible restored with implants who have participated in the core study CR 04/07 will be recruited for this extension study. No further interventions will be made for this extension study other than a clinical follow-up examination and questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaw, Edentulous
- How many people
- 49 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2013to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Male or female patient ≥ 18 years of age who were provided with an implant supported over-denture in the mandible in the course of the core study (CR 04/07).
Who may be able to join
- Subjects must have voluntarily signed the informed consent form
- Patients must be committed to participate in the study until the ten year follow-up examinations
- Subjects must have received treatment in the CR 04/07 core study
- Subjects must have completed 3 year visit of core study
Who cannot join
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene or attend follow up visits
- Use of any investigational drug or device during the study
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term, Prospective, Cohort Study to Evaluate Safety and Efficacy of Two Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants for Removable Prosthesis in Patients With Edentulous Mandibles
Patients with an edentulous mandible restored with implants who have participated in the core study CR 04/07 will be recruited for this extension study. No further interventions will be made for this extension study other than a clinical follow-up examination and questionnaires. Patients will not receive an investigational treatment in this study. Patients will be followed at 5 to 10 years from the date of the original implant loading
Read the detailed description
The primary study objective is to compare implant survival with the Titanium Zirconium (Roxolid™) implant compared the Titanium grade IV (SLActive®) implant between baseline (surgery) and 10 years.
The following outcome parameters will be evaluated at 5 and 10 years post surgery for the two different implant types Straumann® Bone Level SLActive, diameter 3.3 mm, Titanium-Zirconium (Roxolid®) vs. Straumann® Bone Level SLActive implant, diameter 3.3 mm, Titanium Grade IV:
- Implant survival
- Implant success according to Buser et al. (1990)
- Crestal bone level change measured by Orthopantomogram (OPT)
- Soft tissue health
- Clinical measurements
- Prosthetic parts assessments: Success and maintenance
- Oral Health Related Quality of Life (OHRQoL)
- Product Safety (Adverse events and device deficiencies)
- Conditions
- Jaw, Edentulous
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Roxolid | Patient do not receive an intervention in the extension study. Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant. | |
| SLActive | Patient do not receive an intervention in the extension study. Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival
This is a long term follow up extension study including evaluations at 5 and 10 years after the implant procedure from the core study. Implant survival will be assessed based on surviving implants for all patients at 10 years.
Measured: 10 years following implant procedure date
Secondary outcomes (1)
Crestal bone level change
The change in crestal bone level will be measured on standard x-rays taken at 5 and 10 years as per standard of care. An independent reviewer will evaluate all x-rays for the analysis.
Measured: 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frauke Müller, Prof., Study chair, University of Geneva, SwitzerlandBilal Al-Nawas, Prof., Principal investigator, Klinikum der Johannes - Gutenberg - Universität MainzEugenio Romeo, Prof., Principal investigator, Università degli Studi di Milano, Dipartimento di Medicina, Chirurgia e OdontoiatriaJoke Duyck, Prof., Principal investigator, Department of Oral Health Sciences, Catholic University (KU) LeuvenTorsten E Reichert, Prof., Principal investigator, Klinikum der Universität RegensburgAlessandro Perucchi, Prof., Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878331
- Sponsor's protocol ID
- CR 01/13
- Status last verified
- Jan 2020
- First submitted
- 29 Apr 2013
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Muller F, Al-Nawas B, Storelli S, Quirynen M, Hicklin S, Castro-Laza J, Bassetti M, Srinivasan M; Roxolid Study Group. Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: Ten-year results from a double-blind, randomised controlled split-mouth core-trial. Clin Oral Implants Res. 2024 Jan;35(1):77-88. doi: 10.1111/clr.14199. Epub 2023 Nov 9.
PubMed 37942666Muller F, Al-Nawas B, Storelli S, Quirynen M, Hicklin S, Castro-Laza J, Bassetti R, Schimmel M; Roxolid Study Group. Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial. BMC Oral Health. 2015 Oct 12;15(1):123. doi: 10.1186/s12903-015-0107-6.
PubMed 26458813
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term, Prospective, Cohort Study to Evaluate Safety and Efficacy of Two Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants for Removable Prosthesis in Patients With Edentulous Mandibles
- ClinicalTrials.gov ID
- NCT01878331
- Acronym / sponsor ID
- CR 01/13
- Conditions
- Jaw, Edentulous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with an edentulous mandible restored with implants who have participated in the core study CR 04/07 will be recruited for this extension study. No further interventions will be made for this extension study other than a clinical follow-up examination and questionnaires. Patients will not receive an investigational treatment in this study. Patients will be followed at 5 to 10 years from the date of the original implant loading
Detailed description
The primary study objective is to compare implant survival with the Titanium Zirconium (Roxolid™) implant compared the Titanium grade IV (SLActive®) implant between baseline (surgery) and 10 years.
The following outcome parameters will be evaluated at 5 and 10 years post surgery for the two different implant types Straumann® Bone Level SLActive, diameter 3.3 mm, Titanium-Zirconium (Roxolid®) vs. Straumann® Bone Level SLActive implant, diameter 3.3 mm, Titanium Grade IV:
- Implant survival
- Implant success according to Buser et al. (1990)
- Crestal bone level change measured by Orthopantomogram (OPT)
- Soft tissue health
- Clinical measurements
- Prosthetic parts assessments: Success and maintenance
- Oral Health Related Quality of Life (OHRQoL)
- Product Safety (Adverse events and device deficiencies)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxolid | – | –Patient do not receive an intervention in the extension study. Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant. |
| SLActive | – | –Patient do not receive an intervention in the extension study. Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patient ≥ 18 years of age who were provided with an implant supported over-denture in the mandible in the course of the core study (CR 04/07).
Key inclusion criteria (4 listed)
- Subjects must have voluntarily signed the informed consent form
- Patients must be committed to participate in the study until the ten year follow-up examinations
- Subjects must have received treatment in the CR 04/07 core study
- Subjects must have completed 3 year visit of core study
Key exclusion criteria (3 listed)
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene or attend follow up visits
- Use of any investigational drug or device during the study
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implant Survival
Time frame: 10 years following implant procedure date
This is a long term follow up extension study including evaluations at 5 and 10 years after the implant procedure from the core study. Implant survival will be assessed based on surviving implants for all patients at 10 years.
1 secondary outcome
Crestal bone level change
Time frame: 5 and 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 37942666Muller F, Al-Nawas B, Storelli S, Quirynen M, Hicklin S, Castro-Laza J, Bassetti M, Srinivasan M; Roxolid Study Group. Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: Ten-year results from a double-blind, randomised controlled split-mouth core-trial. Clin Oral Implants Res. 2024 Jan;35(1):77-88. doi: 10.1111/clr.14199. Epub 2023 Nov 9.
- Derived from this study: PubMed 26458813Muller F, Al-Nawas B, Storelli S, Quirynen M, Hicklin S, Castro-Laza J, Bassetti R, Schimmel M; Roxolid Study Group. Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial. BMC Oral Health. 2015 Oct 12;15(1):123. doi: 10.1186/s12903-015-0107-6.
- 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.
Frauke Müller, Prof. study chair
University of Geneva, Switzerland
Bilal Al-Nawas, Prof. principal investigator
Klinikum der Johannes - Gutenberg - Universität Mainz
Eugenio Romeo, Prof. principal investigator
Università degli Studi di Milano, Dipartimento di Medicina, Chirurgia e Odontoiatria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaw, Edentulous, run by Institut Straumann AG at 1 site in Switzerland.
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 4 inclusion and 3 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implant Survival (time frame: 10 years following implant procedure date). 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 NCT01878331, which also lists 2 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 7 Jan 2020.