Comparison of Two Implant Prosthetic Pathways

NCT ID: NCT02905838

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2021-06-30

Brief 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 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.

Conditions

Failure of Dental Prosthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anatomic e.max Abutment

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).

Group Type: ACTIVE_COMPARATOR

Anatomic e.max Abutment

Intervention Type: DEVICE

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 Abutment

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).

Group Type: ACTIVE_COMPARATOR

CAD/CAM CARES Abutment

Intervention Type: DEVICE

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.

Interventions

Anatomic e.max Abutment

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).

Intervention Type: DEVICE

CAD/CAM CARES Abutment

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects must have voluntarily signed the informed consent form before any study-related action

2. Males and females with at least 18 years of age

3. Single tooth gaps in the anterior maxilla position 14-24 (FDI)

4. Successfully osseointegrated single tooth implant inserted at least 16 weeks after tooth extraction

5. Full mouth plaque index according to O'Leary ≤ 25%

6. Implant axis compatible with transocclusal screw retention (screw access palatal of incisal edges)

Exclusion Criteria

1. Systemic disease that would interfere with dental implant therapy

2. Any contraindications for oral surgical procedures

3. History of local irradiation therapy

4. Patients who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco

5. Subjects who had undergone administration of any investigational device within 30 days of enrolment in the study

6. 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

7. Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene

8. Pregnant or breastfeeding women

9. Existing implants in the adjacent position

10. Removable dentures or un-restored tooth gaps in the opposing dentition

11. Patients with inadequate oral hygiene or unmotivated for adequate home care

12. Probing pocket depth of ≥ 4 mm on one of the teeth immediately adjacent to the dental implant site

13. Lack of primary stability of the implant

14. Inappropriate implant position for the prosthetic requirements

15. Major simultaneous augmentation procedures

16. Insufficient stability of the implant

17. Screw access position located too close to the planned incisal edge

18. Need of angled abutment due to prosthetic malposition of the implant

19. Height of the abutment is less than 65% of the height of the complete restoration

20. Severe bruxing or clenching habits

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia-Gabriela Wittneben, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bern

References

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.

Reference Type: DERIVED

PMID: 27927884 (View on PubMed)

Other Identifiers

Abutment Study

Identifier Type: -

Identifier Source: org_study_id