Edentulous MaxillaNCT02656823
Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study
A study testing ANKYLOS C/X implant A 6.6 in people with Edentulous Maxilla, run by Dentsply Sirona Implants and Consumables at 1 site in United States.
Trial summary
Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Edentulous Maxilla
- What is being tested?
- ANKYLOS C/X implant A 6.6
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2015to 1 Dec 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the study subjects had to meet all of the following criteria:
- Aged 18-80 years at inclusion.
- Signed informed consent.
- In need of full-arch restoration of the maxilla.
- The following should be considered at inclusion but should be fulfilled at Implant Placement (Visit 3):
- Maxilla: totally edentulous, fulfilling all of the following criteria:
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- History of edentulism: ≥ 6 months and,
- Minimum bone height: ≥ 7 mm and,
- Minimum bone width: ≥ 5.5 mm.
- Mandible: antagonistic natural dentition or tooth/implant borne rehabilitation which can be used to create a stable occlusal fit with the new full-arch restoration of the upper jaw.
Who cannot join
- Any of the following was regarded as a criterion for exclusion from the study:
- Unlikely to be able to comply with study procedures according to Investigator's judgement.
- History of bone augmentation in the maxilla within 6 months prior to surgery.
- Uncontrolled pathologic processes in the oral cavity.
- Bruxism.
- Smoking >10 cigarettes per day.
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- Present alcohol or drug abuse.
- History of radiation therapy in head and neck region.
- History of chemotherapy within 5 years prior to surgery.
- Condition that would compromise post-operative tissue healing or osseointegration.
- Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration.
- Known pregnancy at time of inclusion.
- Current or former participation in a clinical study that may interfere with the present study.
- Involvement in the planning and conduct of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University
Fort Lauderdale, Florida, 33328
About this study
Official title: Implant-fixed Restorations With Short Implants in the Edentulous Maxilla - A Clinical Investigation Over a 5-year Follow-up Period
Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.
Read the detailed description
Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function. The primary objective was to evaluate implant survival.
- Conditions
- Edentulous Maxilla
- Being tested
- ANKYLOS C/X implant A 6.6
- Keywords
- ANKYLOS, Simplant, maxilla, edentulous, short implants
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANKYLOS C/X implant A 6.6Device
Treatment with six (6) 6.6 mm implants and a bridge to restore chewing function of an edentulous maxilla.
| Study group | Role | What they receive |
|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Experimental | ANKYLOS C/X Implant A 6.6 mm Receives: Device: ANKYLOS C/X implant A 6.6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival Rate
Any implant that is removed after implant placement will be considered failure, whatever reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants.
Measured: At Visit 14, 5 years after permanent restoration (PR).
Secondary outcomes (8)
Implant Stability
Implant stability was evaluated clinically/manually by the investigator at implant placement visit (this initial manual check is called primary stability), and again at the abutment surgery visit. The stability evaluation was recorded as yes/no, yes = judged by the investigator to be stable, or no = judged by the investigator to be unstable. Stability was assessed at implant placement (IP) (Visit 3), and at Abutment Surgery and Impression (Visit 5, at 13 weeks after IP).
Measured: At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP).
Mean Marginal Bone Level (MBL) at Subject's Tissue Level
The mean Marginal Bone Level (MBL) on subject level. Bone level response will be evaluated from intra-oral radiographs. The radiographs will be sent for central evaluation to a radiologist who is independent from the investigational group and the Sponsor. The radiologist will measure and record 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. The reference point is defined as the implant shoulder.
Measured: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Mean Marginal Bone Level (MBL) on Implant Level.
The mean Marginal Bone Level (MBL) on implant level. Bone level response will be evaluated from intra-oral radiographs. The radiographs will be sent for central evaluation to a radiologist who is independent from the investigational group and the Sponsor. The radiologist will measure and record 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. The reference point is defined as the implant shoulder.
Measured: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Mean Probing Pocket Depth (PPD) at Subject Level.
PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm.
Measured: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
At Least One Surface With Plaque.
Plaque was recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site (mesially, distally, buccally and lingually).
Measured: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Any Bleeding on Implant (BoP)
BoP was evaluated at each of the four surfaces around the implant site (mesially, distally, buccally and lingually), by using a periodontal probe. BoP was recorded as presence or absence of bleeding when probing to the bottom of the pocket.
Measured: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Oral Health Impact Profile 14 (OHIP-14)
Patient satisfaction was evaluated using the Oral Health Impact Profile 14 (OHIP-14). The questionnaire was filled in by the subjects before and after treatment with implants. OHIP-14 includes seven domains: functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. An example of an OHIP statement is "Have you had to interrupt meals because of problems with your teeth, mouth or dentures". Responses are based on a Likert scale (i.e., 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The lowest possible total score (all question responses summed) of the OHIP-4 questionnaire is 0, and the highest possible score is 56. A high score is linked to a poor outcome.
Measured: At pre-surgical planning (Visit 2) on average 6 months before PR, and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Prosthetic Survival Rate on Subject Level
A prosthetic restoration was considered a survived if the original restoration was still in place, regardless of its condition, at the follow-up visit.
Measured: At 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start24 Nov 2015
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
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.
- Other trials for Edentulous MaxillaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Weigl, Principal investigator, J. W. Goethe-Universität, Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656823
- Sponsor's protocol ID
- C-AN-14-001
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2015
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant-fixed Restorations With Short Implants in the Edentulous Maxilla - A Clinical Investigation Over a 5-year Follow-up Period
- ClinicalTrials.gov ID
- NCT02656823
- Acronym / sponsor ID
- C-AN-14-001
- Conditions
- Edentulous Maxilla
- Keywords
- ANKYLOS, Simplant, maxilla, edentulous, short implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.
Detailed description
Study to assess the performance of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function. The primary objective was to evaluate implant survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANKYLOS C/X Implant A 6.6 | Experimental | Device: ANKYLOS C/X implant A 6.6ANKYLOS C/X Implant A 6.6 mm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-80 years at inclusion.
- Signed informed consent.
- In need of full-arch restoration of the maxilla.
- The following should be considered at inclusion but should be fulfilled at Implant Placement (Visit 3):
- Maxilla: totally edentulous, fulfilling all of the following criteria:
Key exclusion criteria (14 listed)
- Unlikely to be able to comply with study procedures according to Investigator's judgement.
- History of bone augmentation in the maxilla within 6 months prior to surgery.
- Uncontrolled pathologic processes in the oral cavity.
- Bruxism.
- Smoking >10 cigarettes per day.
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 |
|---|---|---|
| ANKYLOS C/X implant A 6.6Treatment with six (6) 6.6 mm implants and a bridge to restore chewing function of an edentulous maxilla. | Device | ANKYLOS C/X Implant A 6.6 |
Primary outcome
Implant Survival Rate
Time frame: At Visit 14, 5 years after permanent restoration (PR).
Any implant that is removed after implant placement will be considered failure, whatever reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants.
8 secondary outcomes
Implant Stability
Time frame: At implant placement (IP) (Visit 3), and at Abutment surgery and Impression (Visit 5, at 13 weeks after IP).
Mean Marginal Bone Level (MBL) at Subject's Tissue Level
Time frame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Mean Marginal Bone Level (MBL) on Implant Level.
Time frame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 1-year after PR (Visit 10), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Mean Probing Pocket Depth (PPD) at Subject Level.
Time frame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
At Least One Surface With Plaque.
Time frame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Any Bleeding on Implant (BoP)
Time frame: At permanent restoration (PR) (Visit 8, at 17 weeks after IP), and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Oral Health Impact Profile 14 (OHIP-14)
Time frame: At pre-surgical planning (Visit 2) on average 6 months before PR, and at 6-months after PR (Visit 9), at 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Prosthetic Survival Rate on Subject Level
Time frame: At 1-year after PR (Visit 10), at 2-years after PR (Visit 11), at 3-years after PR (Visit 12), and at 5-years after PR (Visit 14).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Weigl principal investigator
J. W. Goethe-Universität, Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANKYLOS C/X implant A 6.6 in people with Edentulous Maxilla, run by Dentsply Sirona Implants and Consumables at 1 site in United States.
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 10 inclusion and 14 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 28 Feb 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2024). 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?
Implant Survival Rate (time frame: At Visit 14, 5 years after permanent restoration (PR).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.