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NCT Number: NCT05326880

5-year Follow up Study on the Comparative Performance of Two-piece Zirconia and Titanium Implants

A post-market, randomized-controlled, superiority clinical study to compare medium-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.

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Key information

Conditions

Dental Implants Dental Implant Failed Single Tooth Lost

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik, Düsseldorf, Germany

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About this study

Dental implants are a key modality for tooth replacement. Titanium dental implants have been the mainstay of dental implants as it osseointegrate well. Titanium has a silver gray metallic color and therefore, to hide its presence and enhance the aesthetic appearance, the implant is usually placed deeper into the bone tissue and the gums. This has negative consequences since it becomes more difficult to keep the interface between the dental implant and the crown free from bacterial plaque and inflammation. The use of zirconia（a base form of metal with similar properties of titanium in terms of osseointegration) has attracted a lot of interest because of its color that is similar to the one of natural teeth.This study will hence compare the long term performance of standard 4th generation dental implants made of titanium with a second generation zirconia dental implant. The study will evaluate the occurence of biological and technical complications; patient satisfaction and with the aesthetics of the tooth replacement over time.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

following criteria must be met for inclusion in the study:

  • Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analyzed, and published.
  • Patients must be males or females who are a minimum of 18 years of age.
  • Patients, who have received a single tooth replacement with a study implant as per-protocol in the premolar-to-premolar area (excluding lower incisors) in the mandible and maxilla and restored with a screw retained ceramic crown.

Exclusion criteria

  • Patients with 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.
  • Pregnancy or intention to become pregnant at any point during the study duration.

Treatment and study plan

Ceramic Dental Implant

Device

The ceramic implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading with definitive prosthesis after 6 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.

Titanium Dental Implant

Device

The titanium implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading with definitive prosthesis after 6 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.

Primary outcomes

  1. Bone level change

    Time frame: 5 years after implant loading (final crown restoration)

    Change in crestal bone level measured by analysis of standardized peri-apical xrays 5 years after loading [mm].

Secondary outcomes

  1. Implant survival

    Time frame: 5 years after loading

    Implant survival rates 2, 3, 4, 5 years after loading: yes/no

  2. Complication/event free survival

    Time frame: 5 years after loading

    To compare the complication/event free survival between two-piece ceramic implant and bone level titanium implant at 2, 3, 4, 5 years after loading.

  3. 14 item Oral Health Impact Profile (OHIP-14)

    Time frame: 5 years after loading

    The local language version of the OHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4).

Other outcomes

  1. Adverse Events

    Time frame: 5 years

    Adverse Events will be recorded at every visit throughout the observation period

  2. Device Deficiencies

    Time frame: 5 years

    Any device complications and deficiencies will be recorded as Device Deficiencies.

Study contacts

Contact information is provided by the study sponsor or research team.

George Pelekos, Dr.

CONTACT

[email protected]

+852 2859 0343

Melissa R. Fok, Dr.

CONTACT

[email protected]

+852 2859 0301

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Comparative Performance of Two-piece Zirconia Tissue Level Implants vs. Titanium Bone Level Implants Placed With a Fully Digital Workflow - 5-year Follow up of a Randomized Clinical Trial

Acronym: PostNCT0390817

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Apr 14, 2022
Registry last updated
Nov 21, 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.

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