Dental ImplantsNCT01649531
Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial
A study testing 1 Implant and 2 Implants in people with Dental Implants, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dental Implants
- What is being tested?
- 1 Implant and 2 Implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Aug 2012to 28 Feb 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients 18 years to 80 years of age
- no general medical condition which represents a contraindication to implant treatment
- two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
- at least one tooth present adjacent to the edentulous space
- indication for implant treatment is given
- at least 8 mm of vertical bone height in the mandible allowing for the placement of a 6 mm implant (2 mm safety distance to inferior alveolar nerve)
- at least 4 mm of vertical bone height in the maxilla
- signed informed consent after being informed
Who cannot join
- smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
- poor oral hygiene after hygienic phase (Plaque Index over 30 %)
- active periodontal disease
- pregnancy or breastfeeding at date of inclusion
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center of Dental Medicine Clinic of Reconstructive Dentistry
Zurich, 8032
About this study
The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.
- Conditions
- Dental Implants
- Being tested
- 1 Implant, 2 Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 ImplantProcedure or surgery
2 ImplantsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | 1 Implant, to be placed in the position with greater vertical bone height with a mesial or distal cantilever. Receives: Procedure: 1 Implant |
| Control group | Active comparator | 2 Implants Receives: Procedure: 2 Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic bone level
The primary endpoint of the study is the radiographic bone level 5 years after insertion.The bone level represents an indicator of the osseointegration and biological success of the implant.
Measured: 5 years
Secondary outcomes (6)
Radiographic bone level
Measured: 1, 3, 7, 10 years
Implant survival and success
Measured: 1, 3, 5, 7, 10 years
rate of technical complication
technical complications: screw loosenings, screw fractures, framework fractures, veneering ceramic fractures
Measured: 1, 3, 5, 7, 10 years
rate of biological complications
biological complications: mucositis, assessed by bleeding on probing
Measured: 1, 3, 5, 7, 10 years
Soft tissue changes
Soft tissue changes: change in clinical crown length = recession / papilla index
Measured: 1, 3, 5, 7, 10 years
Patient morbidity
VAS scale to assess pain after implant placement
Measured: 1, 3, 5, 7, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study start9 Aug 2012
- Primary completion26 Feb 2020
- Study completion28 Feb 2025 (estimated)
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 Dental ImplantsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Thoma, Prof. Dr., Principal investigator, Clinic of Reconstructive Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649531
- Sponsor's protocol ID
- 2012-0097
- Status last verified
- May 2023
- First submitted
- 20 Jul 2012
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Strauss FJ, Schiavon L, Naenni N, Kraus RD, Saenz-Ravello G, Muller N, Jung RE, Thoma DS. Cost Effectiveness of Two Short Implants Versus One Short Implant With a Cantilever in the Posterior Region: 7.5-Year Follow-Up of a Randomised Controlled Trial. J Clin Periodontol. 2025 Dec;52(12):1712-1724. doi: 10.1111/jcpe.70039. Epub 2025 Sep 21.
PubMed 40976576Thoma DS, Wolleb K, Schellenberg R, Strauss FJ, Hammerle CHF, Jung RE. Two short implants versus one short implant with a cantilever: 5-Year results of a randomized clinical trial. J Clin Periodontol. 2021 Nov;48(11):1480-1490. doi: 10.1111/jcpe.13541. Epub 2021 Sep 22.
PubMed 34448219
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01649531
- Acronym / sponsor ID
- 2012-0097
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 9 Aug 2012 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 25 Jul 2012 (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.
The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Procedure: 1 Implant1 Implant, to be placed in the position with greater vertical bone height with a mesial or distal cantilever. |
| Control group | Active comparator | Procedure: 2 Implants2 Implants |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male and female patients 18 years to 80 years of age
- no general medical condition which represents a contraindication to implant treatment
- two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
- at least one tooth present adjacent to the edentulous space
- indication for implant treatment is given
Key exclusion criteria (4 listed)
- smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
- poor oral hygiene after hygienic phase (Plaque Index over 30 %)
- active periodontal disease
- pregnancy or breastfeeding at date of inclusion
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 |
|---|---|---|
| 1 Implant | Procedure or surgery | Test group |
| 2 Implants | Procedure or surgery | Control group |
Primary outcome
radiographic bone level
Time frame: 5 years
The primary endpoint of the study is the radiographic bone level 5 years after insertion.The bone level represents an indicator of the osseointegration and biological success of the implant.
6 secondary outcomes
Radiographic bone level
Time frame: 1, 3, 7, 10 years
Implant survival and success
Time frame: 1, 3, 5, 7, 10 years
rate of technical complication
Time frame: 1, 3, 5, 7, 10 years
rate of biological complications
Time frame: 1, 3, 5, 7, 10 years
Soft tissue changes
Time frame: 1, 3, 5, 7, 10 years
Patient morbidity
Time frame: 1, 3, 5, 7, 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Derived from this study: PubMed 40976576Strauss FJ, Schiavon L, Naenni N, Kraus RD, Saenz-Ravello G, Muller N, Jung RE, Thoma DS. Cost Effectiveness of Two Short Implants Versus One Short Implant With a Cantilever in the Posterior Region: 7.5-Year Follow-Up of a Randomised Controlled Trial. J Clin Periodontol. 2025 Dec;52(12):1712-1724. doi: 10.1111/jcpe.70039. Epub 2025 Sep 21.
- Derived from this study: PubMed 34448219Thoma DS, Wolleb K, Schellenberg R, Strauss FJ, Hammerle CHF, Jung RE. Two short implants versus one short implant with a cantilever: 5-Year results of a randomized clinical trial. J Clin Periodontol. 2021 Nov;48(11):1480-1490. doi: 10.1111/jcpe.13541. Epub 2021 Sep 22.
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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.
Daniel Thoma, Prof. Dr. principal investigator
Clinic of Reconstructive Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Implant and 2 Implants in people with Dental Implants, run by University of Zurich 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 May 2023. 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?
Results are not available in the source record.
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?
radiographic bone level (time frame: 5 years). 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 NCT01649531, 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 15 May 2023.