Health Trials

About this trial

The goal of this prospective study is to assess short term (12-months) clinical outcomes of NobelZygoma TiUltra implants and Multi-unit Abutment Xeal in the rehabilitation of participants with severely atrophic maxilla treated with zygomatic dental implant procedure. The main goal is to assess the sinusitis occurrence at 12-months after implant insertion. Other objectives are to assess: soft tissue health; biological and technical complication; patient's experience, outcomes (sinonasal symptoms and oral health-related quality of life) and satisfaction; clinician's experience with handling of device and satisfaction; implant, abutment and prosthetic survival and adverse events.

Participants will be asked to complete questionnaires at pretreatment visit, postoperative visit, and after 6-months and 12-months of implant insertion. At 12-months a radiological exam (CBCT) will be asked for the participant for the evaluation of the radiological condition of the maxillary sinus.

Eligibility criteria

Qualifiers

Participant has signed the informed consent form (ICF).

Participant aged ≥ 18 years at the time of treatment.

Medical and anatomical conditions are in accordance with the applicable IFU.

Participant with a severely atrophic maxilla classified as Cawood and Howell class V or VI

Disqualifiers

Presence of acute or chronic maxillary sinusitis.

Zygomatic bone pathologies including tumors, infections, or congenital abnormalities

History of recurrent sinusitis (≥ 4 occurrences/year)

Pre-operative LM score of ≥ 1

Trial design

Treatments tested in this trial

  • NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant
  • Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 17° Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 45° Multi.Unit Abutment Xeal Zygoma CC RP; 60° Multi-Unit Abutment Xeal Zygoma CC RP

Treatment groups

85 Participants
are divided into 1 treatment group

Locations

2
Italy
Universitiy of Verona, Unit of Stomatology and Maxillo-Facial Surgery37134, Verona Italy
Switzerland
Hirslanden Medical Center5000, Aarau Switzerland

Sponsors and collaborators

Nobel Biocare

Lead sponsor

Source ClinicalTrials.gov