Partial EdentulismNCT06104163
Impact of Cantilever Design on Clinical, Radiographic, and Volumetric Parameters: a Retrospective Study
An observational study of Partial Edentulism, run by University of Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2015to 27 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Cantilever Design in the Posterior Areas of the Mandible on Clinical, Radiographic, and Volumetric Parameters: a Retrospective Study With 8-year Follow-up
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.
Read the detailed description
Implant rehabilitation of posterior edentulous areas of the mandible is very complex because the presence of noble structures, such as the inferior alveolar nerve (NAI), often requires major reconstructive procedures to achieve adequate bone volume before implant placement.
To overcome these potential problems and provide patients with sufficient function and esthetics, the use of single-unit crowns (SCs) supported by implants with cantilever extensions was introduced. The length and design of cantilever extensions are associated with possible detrimental effects on implant and prosthetic survival. In light of the above, the objective of the present study is 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 years
Keratinized mucosa (KM)
Evaluation of Keratinized mucosa width (KM), measured from the restoration margin to the mucogingival junction and expressed in mm.
Measured: 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 (-);
Measured: 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).
Measured: 8 years
Secondary outcomes (2)
Volumetric analysis at baseline and after 8 years of follow-up
It was obtained by superimposing the intraoral scans of each patient, performed at baseline and eight years later through an optical scanner (3 Shape TRIOS 3 Germany GmbH), using 3D imaging software. The volumetric differences affecting the peri-implant soft tissues following prosthetic loading were expressed as a percentage and in mm3.
Measured: 8 years
Radiographic examination at baseline and after 8 years of follow-up
All patients enrolled in the study underwent periapical radiography performed with the long parallel cone technique at baseline and 8 years after. The measure linear peri-implant marginal bone levels (BML) of single unit crowns (SCs) is the perpendicular distance, expressed in mm, from the mesial and distal edge of the implant shoulder to the first bone-to-implant contact (BIC).
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Jan 2015
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104163
- Sponsor's protocol ID
- 121-28
- Status last verified
- May 2024
- First submitted
- 25 Jul 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cantilever Design in the Posterior Areas of the Mandible on Clinical, Radiographic, and Volumetric Parameters: a Retrospective Study With 8-year Follow-up
- ClinicalTrials.gov ID
- NCT06104163
- Acronym / sponsor ID
- 121-28
- Conditions
- Partial Edentulism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Implant rehabilitation of posterior edentulous areas of the mandible is very complex because the presence of noble structures, such as the inferior alveolar nerve (NAI), often requires major reconstructive procedures to achieve adequate bone volume before implant placement.
To overcome these potential problems and provide patients with sufficient function and esthetics, the use of single-unit crowns (SCs) supported by implants with cantilever extensions was introduced. The length and design of cantilever extensions are associated with possible detrimental effects on implant and prosthetic survival. In light of the above, the objective of the present study is 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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);
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Probing Depth of the Peri-implant Pocket (PPD)
Time frame: 8 years
It is measured from the mucosal margin to the bottom of the probable peri-implant sulcus and expressed in mm.
Plaque Index (PI)
Time frame: 8 years
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.
Keratinized mucosa (KM)
Time frame: 8 years
Evaluation of Keratinized mucosa width (KM), measured from the restoration margin to the mucogingival junction and expressed in mm.
Mucosal recession (MR)
Time frame: 8 years
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 (-);
Bleeding and/or suppuration on probing (BOP/SUP)
Time frame: 8 years
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).
2 secondary outcomes
Volumetric analysis at baseline and after 8 years of follow-up
Time frame: 8 years
Radiographic examination at baseline and after 8 years of follow-up
Time frame: 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano Isola principal investigator
University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial Edentulism, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Depth of the Peri-implant Pocket (PPD) (time frame: 8 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.