Completed

NCT Number: NCT02905838

Comparison of Two Implant Prosthetic Pathways

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.

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Key information

Conditions

Failure of Dental Prosthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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
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

Treatment and study plan

Anatomic e.max Abutment

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

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.

Primary outcomes

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

Secondary outcomes

Change in Clinical Peri-implant Measurements

Time frame: baseline, 6 months, 1 year, 3 years, 5 years
Implant Success

Time frame: baseline, 6 months, 1 year, 3 years, 5 years
Survival Rate

Time frame: baseline, 6 months, 1 year, 3 years, 5 years
Cast Analysis

Time frame: baseline, 6 months, 1 year, 3 years, 5 years

Change in reference tooth-crown length and implant-crown length in mm
Number of Technical Complications of the Implant Crown

Time frame: baseline, 6 months, 1 year, 3 years, 5 years

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2020
Study completion: 2021
First posted: Sep 19, 2016
Registry last updated: May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.