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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05526547
Other study ID # cantilever
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date June 30, 2022

Study information

Verified date April 2023
Source D'Albis Dental
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Fifteen partially edentulous patients received 34 implants and were provided 16 zirconia fixed partial prostheses (FPPs) with one cantilever extension replacing mandibular or maxillary missing posterior and lateral teeth. Patients were re-examined up to 4 years.


Description:

The investigators consecutively enrolled 15 patients who required dental implant rehabilitation with fixed dental prosthesis. All patients were attended at a private out-patient clinic from 2018 to 2021.The study was conducted in Italy and all procedures respect European laws and regulations.A diagnostic wax-up of the missing teeth was performed on digital casts for each case. Each case was designed using software planning the implant position in the distal part of the edentulous ridge where the bone conditions were more favorable.The surgical procedures were performed according to the protocols given by manufacturers.The implant site was prepared after raising a full-thickness flap. The implant was placed as designed in the digital planning with the support of a surgical guide.The patients were recalled 3-6 months after surgery for a pre-prosthetic evaluation. A healing abutment was placed, and implant stability was proven.Three weeks after second-stage surgery, the definitive digital impression was taken using an intraoral scanner. The prosthetic procedures were performed according to manufacturers' implant system recommendations. All prostheses were designed using CAD software with a connector cross-sectional area of at least 12 mm2. Monolithic zirconia fixed partial dentures were fabricated using a CAD-CAM unit from pre-sintered, pre-shade zirconia blanks . The fixed dentures were characterized with ceramic-based colors. The screw-retained zirconia prosthesis were subsequently inserted, and a check of the occlusion was performed.The patients get a baseline examination after 1-3 weeks of final prosthesis insertion. Aesthetics, proximal contacts, and occlusion were modified when needed following a careful examination. Patients were recalled at least once a year to assess the restorations functionally and aesthetically, peri-implant tissues, and implant health status. An individual maintenance program with regular dental hygiene sessions was performed during the entire study period for every patient, and an x-ray was taken at the 2-year follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date June 30, 2022
Est. primary completion date January 30, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Good health according to the System of the American Society of Anesthesiology - Aged older than 18 years - No general medical contraindication for implant therapy - Two or more missing teeth from the canine to the second molar - Good periodontal health or treated periodontitis Exclusion Criteria: - Smoking more than 15 cigarettes a day - Untreated periodontitis - Pregnancy - Acute infections - Keratinized mucosal tissue less than 2 mm.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Giuseppe D'Albis Mola di Bari Bari

Sponsors (1)

Lead Sponsor Collaborator
D'Albis Dental

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prosthesis Evaluation of prosthetic clinical complication of the Fixed Partial Dentures: zirconia chipping (yes or not), zirconia Fracture (yes or not) , loosening of abutment screw (yes or not). 4 years
Secondary Implant Evaluation of biological complication implants related. Clinical outcome: mucositis(yes or not: blending on probing) , periimplantitis (yes or not: supuration and 3mm at least of marginal bone loosening), implants fractures (yes or not). 4 years
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