NobelZygoma TiUltra Implant System Study

ConditionsEdentulous Maxilla Maxillary Bone Loss Atrophic Maxilla

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNobel Biocare

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant
Device
All participants will receive NobelZygoma TiUltra implant and Multi-unit Abutment Xeal as part of the implant/prosthetic zygomatic rehabilitation procedure. Implants and abutments will be selected as per surgeon preference and participant's need. Radiological exam will be performed at pre-treatment and 12-months follow-up. Patients will be followed-up after placement of implant at 10-days, 6-months and 12-months follow-up. At 12-months a standardized clinical and radiological criteria (using the SNOT-22 and Lund-Mackay respectively) will be used to describe and quantify the occurrence of maxillary sinusitis across all study centers for the sinusitis diagnose.
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
Device
All participants will receive NobelZygoma TiUltra implant and Multi-unit Abutment Xeal as part of the implant/prosthetic zygomatic rehabilitation procedure. Implants and abutments will be selected as per surgeon preference and participant's need. Radiological exam will be performed at pre-treatment and 12-months follow-up. Patients will be followed-up after placement of implant at 10-days, 6-months and 12-months follow-up. At 12-months a standardized clinical and radiological criteria (using the SNOT-22 and Lund-Mackay respectively) will be used to describe and quantify the occurrence of maxillary sinusitis across all study centers for the sinusitis diagnose

Treatment groups

85 Participants

are divided into 1 treatment group

Group A: NobelZygoma TiUltra implant system in the rehabilitation of severely atrophic maxillaeOther 2 interventions

Trial outcomes

Primary outcomes

Maxillary sinusitis at 12-months post-implant placement

The diagnosis of maxillary sinusitis is based on the following criteria: A positive clinical diagnosis is made when all of the following criteria from SNOT-22 are met simultaneously: 1. The participant reports at least two clinical symptoms, one of which must be either: nasal blockage/obstruction/congestion, or nasal discharge (anterior or posterior nasal drip). Additional symptoms may include: facial pain or pressure, reduction or loss of smell. 2. There is a clinically significant worsening in symptoms, demonstrated by a ≥12-point increase in the total SNOT-22 score from baseline (pre-treatment). 3. If the participant exhibits partial symptoms or if the diagnosis remains uncertain, the Principal Investigator (PI) will refer the participant to an ENT specialist for further evaluation.

Time frame

At 12-months follow-up of zygomatic implant insertion

Secondary outcomes

PREMs

Evaluate patient reported experience measures (PREMs) from pre-treatment to 12-month follow-up using Likert scale

Time frame

At pre-treatment; and after 10 days, 6- and 12-months of zygomatic implant placement

Pain assessment

Assess patient reported pain at postoperative visit using VAS scale (from 0 (no pain) to 100 (worst pain possible)

Time frame

10 days after zygomatic implant placement

Patient satisfaction

Assess patient satisfaction with function and esthetics using VAS scale (from 0 - not satisfied to 100 fully satisfied

Time frame

10 days, 6-months and 12-months after zygomatic implant placement

OHIP-21

Evaluate oral health-related quality of life using OHIP-21 questionnaire from pre-treatment to 12-month follow-up.

Time frame

At pre-treatment and after 10 days, 6-months and 12-months of zygomatic implant placement

Other outcomes

Prosthetic survival

To evaluate prosthetic survival rate

Time frame

From placement until 12-months follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nobel Biocare

Lead sponsor

Source ClinicalTrials.gov

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