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Tooth LossNCT02163395

Performance Evaluation of FullCeram Implants in Single Tooth Gaps

A study testing FullCeram implant in people with Tooth Loss, run by Institut Straumann AG at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Straumann Monotype FullCeram implants serve as a suitable alternative for implant therapy especially in the aesthetic zone The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant losses out of 40 patients) after the first year Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tooth Loss
What is being tested?
FullCeram implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
3 sitesGermany
Study dates
Oct 2011to 21 Nov 2023
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject must have voluntary signed the informed consent and the data protection consent form before any study related action
  • Males and females with at least 18 years of age (including 18 years)
  • Implant placement planned in the maxilla or mandible
  • The missing tooth site must have a tooth with a natural root
  • Substantially healed and augmented extraction sockets (minimal 8 weeks)
  • Autogenous bone augmentation until 3 month pre-implantation were bone deficiency jeopardizing the implant position

Who cannot join

  • Pre-surgical exclusion criteria:
  • Systemic disease that would interfere with dental implant therapy
  • Any contraindications for oral surgical procedures
  • Mucosal diseases
  • History of local irradiation therapy
  • Current untreated periodontitis or gingivitis
Show all 20Show fewer
  • Any untreated endodontic lesions
  • Probing pocket depth of > or = 4 mm on one of the teeth immediately adjacent to the dental implant site
  • Severe bruxing or clenching habits
  • Patients with inadequate oral hygiene or unmotivated for adequate home care
  • Patients who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco
  • Subjects who have undergone administration of any investigational device within 30 days of enrolment in 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 or unreliability
  • Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
  • Pregnant women at screening
  • Secondary exclusion criteria at or after implant surgery:
  • Lack of primary stability of the implant (hand testing directly after surgery)
  • Inappropriate implant position for the prosthetic requirements (to be estimated before provisional restoration)
  • Major simultaneous augmentation procedures (at surgery)
  • X-ray of implant does not show the implant from first bone contact to apical tip (at surgery)

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Medizinische Hochschule Hannover Klinik und Poliklinik fuer Mund-, Kiefer- und Gesichtschirurgie

    Hanover, 30625

  • Oralchirurgie T1

    Munich, 80333

  • Katharinenhospital

    Stuttgart, 70174

Other trials in Germany

About this study

Official title: A Prospective Open Label Single Arm Study to Evaluate the Performance of Straumann Monotype FullCeram (Zirconium Dioxide) Implants in Single Tooth Gaps in the Maxilla and Mandible

  • Straumann Monotype FullCeram implants serve as a suitable alternative for implant therapy especially in the aesthetic zone
  • The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant losses out of 40 patients) after the first year
Read the detailed description

This is a prospective, open label, single arm, multicenter study. The total study duration for each patient was prolonged to 10 years follow-up. It is acceptable to have the visit performed up to 6 month after the aspired date.

The primary study parameter will be analyzed as soon as every patient passed visit 6 (annual follow-up visit, 12 month +/- 4 weeks).

Implants will be placed transmucosally and will be protected by a thermoplastic splint for healing. A provisional prosthesis will be placed (out of occlusion) 12-14 weeks post implant placement. The final crown will be done between study week 24 and 28. Implant survival, implant success, bone loss, periodontal parameters and adverse events will be assessed in the follow-up visits.

In total 10 visits are scheduled in this study. The investigational device: Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm. This is a CE marked product.

Three centres in Germany are participating. The study and any amendments will be performed as far as possible according to ISO 14155 (Second Edition, 2011-02-01) and conform to the Declaration of Helsinki (last revised Seoul 2008) and local legal and regulatory requirements.

Conditions
Tooth Loss
Being tested
FullCeram implant
Keywords
Ceramic implant
Medical subject headings
Tooth Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FullCeram implantDevice

    Also called Straumann Monotype FullCeram (Zirconium dioxide)

    FullCeram implantation

Study groups in NCT02163395
Study groupRoleWhat they receive
FullCeram implantOtherStraumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm
Receives: Device: FullCeram implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Implant Survival

    A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.

    Measured: Measured at 12 months +/- 4 weeks after implant placement

Secondary outcomes (3)

  1. The Implant Success

    According to Buser et al 1992 an implant will be deemed a success if all of the following success criteria apply.

    • Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation)
    • Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics)
    • Absence of implant mobility on manual palpation
    • Absence of any continuous peri-implant radiolucency

    Measured: Measured at Week 26, Month 12, Month 24 and Month 36

  2. Mean Bone Level Changes (Distal and Mesial)

    A radiographic stent was produced to have a standard measurement. The distal and mesial bone levels were combined into a single value by averaging the two values. Negative bone level changes representing bone loss between baseline and follow-up visits, vice versa positive changes representing bone gain.

    Measured: Measured at Week 26, Month 12, Month 24 and Month 36

  3. The Implant Survival

    A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.

    Measured: Measured at Week 26, Month 24 and Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2014 (estimated)
  2. Study startOct 2011
  3. Primary completionSep 2013
  4. Study completion21 Nov 2023

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02163395
Sponsor's protocol ID
CR 01/07
Status last verified
May 2022
First submitted
10 Jun 2014
Last updated
22 Nov 2023
Data monitoring committee
No
Individual data sharing
No

Publications

  • Lambrecht TJ, Filipi A, Raetzer Luenzel A, Schiel HJ. Long-Term evaluation of submerged and nonsubmerged ITI solid-screw titanium implants. A 10-year life table analysis of 468 implants. Int J Oral Maxifollofac Implants; 18:826-834, 2003. Kohal R J, et al. Loaded custom-made zirconia and titanium implants show similar osseointegration: an animal experiment. J Periodontol. 75.9, 1262-68, 2004. Scarano A, et al. Bone response to zirconia ceramic implants: an experimental study in rabbits. J Oral Implantol. 8-12, 29.1, 2003. Sennerby L, at al. Bone tissue resonses to surface-modified zirconia implants: A histomorphometric and removal torque study in the rabbit. Clin. Implant. Dent.Relat Res. 7 Suppl: S13-S20, 2005. Blaschke C, and Volz U. Soft and hard tissue response to zirconium dioxide dental implants - a clinical study in man. Neuro.Endocrinol.Lett. 27.Suppl1, 2006. Olivia J, Olivia X, Olivia JD. One year follow-up of first consecutive 100 Zirconia Dental Implants in humans: A comparison of 2 different rough surfaces. Int J Oral Maxillofac Implants; 22:430-435, 2007. Herrmann JS, Buser D, Schenk RK, Schoolfield JD, Cochran DL. Biologic width around one-and two-piece titanium implants. A histometric evaluation of unloaded nonsubmerged and submerged implants in the canine mandible. Clin Oral Impl Res 12, 559-571, 2001. Todescan FF, Pustiglioni FE, Imbronito AV, Albrektson T, Gioso M. Influenze of the microgap in the peri-implant hard and soft tissues. A histomorphometric study in dogs. Int J Pral Maxillofac Implants 17:467-472, 2002. Buser D, Weber HP, Braegger U, Balsinger C. Gewebeintegration einphasiger ITI-Implantate: Drei-Jahres-Ergebnisse einer prospektiven Langzeitstudie mit Hohlzylinder- und Hohlschraubenimplantaten. Buser D, Martin W, Belser UC. Optimizing Esthetics for Implant restorations in the Anterior Maxilla: Anatomic and Surgical Considerations. Int. J Oral and Maxillofacial Implants. Supplement; 19:43-61, 2004.

  • Roehling S, Bormann KH, Bornstein MM, Laval S, Thieringer F, Gahlert M. Long-Term Clinical, Radiographic and Esthetic Outcomes of Zirconia Dental Implants: A 10-Year Prospective Multicenter Study. Clin Oral Implants Res. 2026 Apr;37(4):439-452. doi: 10.1111/clr.70089. Epub 2026 Jan 22.

    PubMed 41568986

  • Bormann KH, Gellrich NC, Kniha H, Schild S, Weingart D, Gahlert M. A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth edentulous area: 3-year follow-up. BMC Oral Health. 2018 Nov 1;18(1):181. doi: 10.1186/s12903-018-0636-x.

    PubMed 30382850

Questions about this trial

What is this clinical trial studying?

A study testing FullCeram implant in people with Tooth Loss, run by Institut Straumann AG at 3 sites in Germany.

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 20 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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 16 Jul 2015). 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?

The Implant Survival (time frame: Measured at 12 months +/- 4 weeks after implant placement). 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 NCT02163395, 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 22 Nov 2023.

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