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Failure of Dental ProsthesisNCT02905838

Comparison of Two Implant Prosthetic Pathways

A study testing Anatomic e.max Abutment and CAD/CAM CARES Abutment in people with Failure of Dental Prosthesis, run by University of Bern.

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

To assess and compare the esthetic outcome and clinical performance of anterior maxillary all ceramic implant single crowns based either on prefabricated zirconia abutment veneered with pressed ceramics or on a CAD/CAM (computer-aided design and computer-aided manufacturing) CARES® abutment veneered with hand build-up… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Failure of Dental Prosthesis
What is being tested?
Anatomic e.max Abutment and CAD/CAM CARES Abutment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Dec 2010to Jun 2021
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must have voluntarily signed the informed consent form before any study-related action
  • Males and females with at least 18 years of age
  • Single tooth gaps in the anterior maxilla position 14-24 (FDI)
  • Successfully osseointegrated single tooth implant inserted at least 16 weeks after tooth extraction
  • Full mouth plaque index according to O'Leary ≤ 25%
  • Implant axis compatible with transocclusal screw retention (screw access palatal of incisal edges)

Who cannot join

  • Systemic disease that would interfere with dental implant therapy
  • Any contraindications for oral surgical procedures
  • History of local irradiation therapy
  • Patients who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco
  • Subjects who had 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
Show all 20Show fewer
  • Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
  • Pregnant or breastfeeding women
  • Existing implants in the adjacent position
  • Removable dentures or un-restored tooth gaps in the opposing dentition
  • Patients with inadequate oral hygiene or unmotivated for adequate home care
  • Probing pocket depth of ≥ 4 mm on one of the teeth immediately adjacent to the dental implant site
  • Lack of primary stability of the implant
  • Inappropriate implant position for the prosthetic requirements
  • Major simultaneous augmentation procedures
  • Insufficient stability of the implant
  • Screw access position located too close to the planned incisal edge
  • Need of angled abutment due to prosthetic malposition of the implant
  • Height of the abutment is less than 65% of the height of the complete restoration
  • Severe bruxing or clenching habits

About this study

Official title: Comparison of the Esthetic and Clinical Performance of Implant Supported All Ceramic Crowns Using Two Different Ceramic Abutment Types

To assess and compare the esthetic outcome and clinical performance of anterior maxillary all ceramic implant single crowns based either on prefabricated zirconia abutment veneered with pressed ceramics or on a CAD/CAM (computer-aided design and computer-aided manufacturing) CARES® abutment veneered with hand build-up technique.

Participants will be recruited from the patient population who has previously received dental implant treatment, received a provisional restoration and met the inclusion and exclusion criteria according to the study protocol. After final impression, patients will be randomised into Group A (prefabricated anatomic abutments ): one-piece screw retained single crown using a press technique (fluorapatite glass-ceramic, e.max ZirPress) with cut-back technique or Group B (CAD/CAM CARES® abutments): one- piece screw retained single crown with a hand build-up technique (fluorapatite veneering ceramic, e.max Ceram). One week after final restoration (base line visit) the primary and secondary outcome parameters will be assessed. The patients will be followed up to 5 years after final restoration.

Being tested
Anatomic e.max Abutment, CAD/CAM CARES Abutment

What participants receive

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

  • Anatomic e.max AbutmentDevice

    Implant-supported single crown was fabricated using a prefabricated stock abutment made of yttrium oxide partially stabilized tetragonal zirconia polycrystalline (Y-TZP) (Anatomic IPS e.max Abutment, straight, color M1, Ivoclar, Liechtenstein) and pressed ceramic (fluorapatite glass-ceramic, IPS e.max ZirPress, Ivoclar, Liechtenstein) using the cut-back technique and hand veneered with a thin layer of fluorapatite veneering ceramic (fluorapatite veneering ceramic, IPS e.max Ceram, Ivoclar, Liechtenstein).

  • CAD/CAM CARES AbutmentDevice

    Implant-supported single crown was fabricated using an individualized CAD/CAM abutment made of Y-TZP (CARES® Abutment, Institut Straumann AG, Basel, Switzerland) and hand build-up veneering ceramic technique (fluorapatite veneering ceramic, IPS e.max Ceram, Ivoclar, Liechtenstein).

    All implant-supported crowns were fabricated in the same dental laboratory by the same dental technician (Dominique Vinci, Geneva, Switzerland). The implants were placed by experienced oral surgeons in a prosthetic ideal position.

Study groups in NCT02905838
Study groupRoleWhat they receive
Anatomic e.max AbutmentActive comparatorImplant-supported single crown was fabricated using a prefabricated stock abutment made of yttrium oxide partially stabilized tetragonal zirconia polycrystalline (Y-TZP) (Anatomic IPS e.max Abutment, straight, color M1, Ivoclar, Liechtenstein) and pressed ceramic (fluorapatite glass-ceramic, IPS e.max ZirPress, Ivoclar, Liechtenstein) using the cut-back technique and hand veneered with a thin layer of fluorapatite veneering ceramic (fluorapatite veneering ceramic, IPS e.max Ceram, Ivoclar, Liechtenstein).
Receives: Device: Anatomic e.max Abutment
CAD/CAM CARES AbutmentActive comparatorImplant-supported single crown was fabricated using an individualized CAD/CAM abutment made of Y-TZP (CARES® Abutment, Institut Straumann AG, Basel, Switzerland) and hand build-up veneering ceramic technique (fluorapatite veneering ceramic, IPS e.max Ceram, Ivoclar, Liechtenstein).
Receives: Device: CAD/CAM CARES Abutment

What is being measured

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

  1. Change in Aesthetic scores: Pink Esthetic Score / White Esthetic Score (PES WES) baseline, 6 months, 1, 3, 5 years performed by 2 independent observers in each center

    Measured: baseline, 6 months, 1 year, 3 years, 5 years

Secondary outcomes (5)

  1. Change in Clinical Peri-implant Measurements

    Measured: baseline, 6 months, 1 year, 3 years, 5 years

  2. Implant Success

    Measured: baseline, 6 months, 1 year, 3 years, 5 years

  3. Survival Rate

    Measured: baseline, 6 months, 1 year, 3 years, 5 years

  4. Cast Analysis

    Change in reference tooth-crown length and implant-crown length in mm

    Measured: baseline, 6 months, 1 year, 3 years, 5 years

  5. Number of Technical Complications of the Implant Crown

    Measured: baseline, 6 months, 1 year, 3 years, 5 years

Timeline

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

  1. First posted19 Sep 2016 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2020
  4. Study completionJun 2021

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02905838
Sponsor's protocol ID
Abutment Study
Status last verified
May 2023
First submitted
6 Sep 2016
Last updated
15 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wittneben JG, Gavric J, Belser UC, Bornstein MM, Joda T, Chappuis V, Sailer I, Bragger U. Esthetic and Clinical Performance of Implant-Supported All-Ceramic Crowns Made with Prefabricated or CAD/CAM Zirconia Abutments: A Randomized, Multicenter Clinical Trial. J Dent Res. 2017 Feb;96(2):163-170. doi: 10.1177/0022034516681767. Epub 2016 Dec 7.

    PubMed 27927884

Questions about this trial

What is this clinical trial studying?

A study testing Anatomic e.max Abutment and CAD/CAM CARES Abutment in people with Failure of Dental Prosthesis, run by University of Bern.

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 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Change in Aesthetic scores: Pink Esthetic Score / White Esthetic Score (PES WES) baseline, 6 months, 1, 3, 5 years performed by 2 independent observers in each center (time frame: baseline, 6 months, 1 year, 3 years, 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 NCT02905838, 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 15 May 2023.

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