Impact of Cantilever Design on Clinical, Radiographic, and Volumetric Parameters: a Retrospective Study

NCT06104163 | Completed

• 1 other identifier: 121-28
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The present retrospective study aims to evaluate the impact of cantilever design in the posterior areas of the mandible on clinical, radiographic, and volumetric parameters with an 8-year follow-up.

Conditions

Partial Edentulism

Outcome Measures

Primary Outcomes (5)

• Probing Depth of the Peri-implant Pocket (PPD)

  It is measured from the mucosal margin to the bottom of the probable peri-implant sulcus and expressed in mm.

  8 years

• Plaque Index (PI)

  Evaluation of Plaque index (PI), expressed as the percentage of positive sites and measured at 4 implant sites (mesio-buccal, mesio-oral, disto-buccal and disto-oral) throught Michigan-grade periodontal probe.

  8 years

• Keratinized mucosa (KM)

  Evaluation of Keratinized mucosa width (KM), measured from the restoration margin to the mucogingival junction and expressed in mm.

  8 years

• Mucosal recession (MR)

  Mucosal recession (MR), of the peri-implant soft tissue, measured from the restoration margin to the mucosal margin and expressed in mm. Coronal from restoration margin is defined as (+) and apical from restoration margin defined as (-);

  8 years

• Bleeding and/or suppuration on probing (BOP/SUP)

  Evaluation of Bleeding and/or suppuration on probing (BOP/SUP), within 30 seconds after probing and expressed as the percentage of positive sites and measured at 4 implantation sites (mesio-buccal, mesio-oral, disto-buccal and disto-oral).

  8 years

Secondary Outcomes (2)

• Volumetric analysis at baseline and after 8 years of follow-up

  8 years

• Radiographic examination at baseline and after 8 years of follow-up

  8 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with partial edentulism, treated comprehensively and continuously between 2015 and 2023, were enrolled at the School of Dentistry of the Department of General Surgery and Medical-Surgical Specialties, University of Catania, Catania, Italy, and a private outpatient regimen.

You may qualify if:

• Patients aged ≥18 years;
• Patients with partial edentulism;
• Patients with systemic health or controlled medical conditions;
• Patients with healthy or treated periodontal conditions;
• Patients enrolled in regular supportive periodontal therapy (SPT);
• Patients without clinical signs of oral parafunctions (bruxism or clenching);
• Presence of 1 osteointegrated dental implant in posterior region (premolar or molar) of mandible, after transmucosal placement and healing at 3-6 months;
• Tissue level solid-screw implants with a sand-blasted and acid etched (SLA) surface with an endosseous diameter of 4.1 mm, a length of 8, 10 or 12 mm, a shoulder diameter of 4.8 mm and a supracrestal machined neck with a height of 1.8 mm (Straumann Dental Implant System, Institute Straumann AG); Use of prefabricated titanium abutments;
• Monolithic zirconia SCs manufactured by digital flow; Screwed SCs with a mesial or distal cantilever extension;
• Alternative crown design (ACD) with eccentric implant insertion, with crown-like-premolar and with distal or mesial cantilever with ovoid conformation. In the latter case, the lower abutment cross-section in the region between the crown-bridge connector mimics the shape of a root, creating an "interradicular" access route to facilitate oral hygiene maneuvers;
• Absence of occlusal contacts or guidance on the cantilever extension at baseline;
• Opposing dentition consisting of natural teeth or fixed or removable restorations;
• Availability of periapical radiography at baseline (i.e., loading of SCs) and at the analyzed timings (after 1, 3, 5, and 8 years);
• Availability of clinical measurements, such as pocket probing depth (PPD), plaque index (PI), bleeding index at probing (BOP), suppuration at probing (SUP), keratinized mucosa (KM), and mucosal recession (MR) taken at baseline (i.e., at loading of the SCs) and at 8 years after SCs loading, at four sites/implant with a Michigan graded periodontal probe (Deppeler SA); Availability of intraoral scans at baseline (i.e., at loading of the SCs) and at the analyzed time points (after 1, 3, 5, and 8 years after SCs loading) and executed using 3 Shape TRIOS 3, Germany GmbH.

You may not qualify if:

• Untreated or active periodontal diseases;
• Type I implant placement;
• SCs with cantilever extension replacing mandibular and maxillary incisors and canines; - - SCs with cantilever extension replacing posterior maxillary;
• SCs with cantilever extension supported by implants with a diameter ≤3.5 mm;
• SCs supported by hollow-screw and hollow-cylinder implants;
• Technical complications, such as fractures of implants, abutments, and the prosthetic artifact;
• Smoking habit (more than 15 cigarettes/day);
• Drug or alcohol abuse;
• Uncontrolled systemic diseases that could affect bone remodeling during implant osseointegration; or soft tissue healing (e.g., uncontrolled diabetes mellitus with HbA1c\>7, osteoporosis);
• Use of medications that could affect bone remodeling during implant osseointegration or soft tissue healing (e.g., steroids, antiresorptive medication, radiotherapy);
• Autoimmune and/or inflammatory diseases affecting the oral cavity;
• Neurological or psychiatric handicap that could interfere with oral hygiene;
• Pregnancy or lactation periods.

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

Location

Study Officials

• Gaetano Isola

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: October 27, 2023
• Study Start: January 1, 2015
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)