Implant-supported Fixed Dental Prostheses (FDPs) With Cantilever Extension

Peri-Implantitis Clinical Trial

Official title:

Clinical and Radiographic Outcomes of Implant-supported Full-ceramic Partial Fixed Dental Prostheses With Cantilever Extension: A Proof of Principle Study With a Follow-up of at Least 1 Year

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676268
• Other study ID #: FDPs with cantilever
• Status: Recruiting
• Start date: January 2, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: University of Bern
• Contact: Jean-Claude Imber, DDS
• Phone: +41 31 632 25 89
• Email: jean-claude.imber[@]zmk.unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To report the clinical and radiographic outcomes of implant-supported fixed dental prostheses with full-ceramic cantilever extensions (FDPCs) after a function time ≥ 12 months.

Description:

Patients with full ceramic FDPCs in anterior and posterior areas will be clinically and radiographically re-evaluated. Mesial and distal radiographic marginal bone levels (mBLs) from baseline (i.e. delivery of FDPC) to the follow-up examination were calculated and compared between implant surfaces adjacent to and distant from the cantilever extension. Implant survival rate (%), pocket probing depth (PPD), presence/ absence of bleeding on probing (BoP) and presence/absence of mechanical/technical and biological complications were recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients aged =18 years

• Written informed consent

• 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 bruxism and/or oral parafunctions

• 2 osseointegrated dental implants in the canine or posterior areas of maxilla and mandible following transmucosal placement and healing of 3-6 months

• Tissue level solid-screw implants with a sand-blasted and acid- etched (SLA) surface with an endosseous diameter of 3.3, 4.1 or 4.8 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 or 2.8 mm (Straumann® Dental Implant System, Institut Straumann AG, Basel, Switzerland)

• Full-ceramic

• Utilization of prefabricated titanium abutments

• Cemented (3M™ ESPE Ketac™ Cem, Seefeld, Germany) or screw-retained fixed dental prostheses with a mesial or distal cantilever extension (FDPCs)

• Cantilever extension corresponding to 1 premolar unit (i.e., 6-7 mm)

• Absence of occlusal contacts or guidance on the cantilever extension at baseline

• Opposing dentition consisting of natural teeth or fixed or removable prosthetic restorations

• Availability of a periapical radiograph at baseline (i.e. FDPC delivery)

• Availability of PPD measurements (mm) taken at baseline at 4 sites/implant with a graduated Michigan periodontal probe (Deppeler SA, Rolle, Switzerland)

• Availability of BoP measurements (%) (Lang et al., 1986) taken at baseline at 4 sites/implant with a graduated Michigan periodontal probe (Deppeler SA, Rolle, Switzerland).

Exclusion Criteria:

• Untreated or active periodontal diseases

• Immediate implant placement (i.e., Type I implant placement according to Hämmerle et al., 2004)

• FDPCs in the aesthetic zone (i.e., replacement of maxillary or mandibular incisors)

• FDPCs supported by hollow-screw and hollow-cylinder implants

Related Conditions & MeSH terms

• Dental Implant Failed
• Peri-Implantitis
• Prosthesis Failure

Intervention

Procedure:
• Implant-supported fixed dental prostheses with cantilever extension
Healthy patients in need of replacement of missing teeth with dental implants supporting partial fixed dental prostheses with cantilever extensions

Locations

Country	Name	City	State
Switzerland	Department of Periodontology, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival rate	Percentage of dental implants present at follow-up visit	12 months
Secondary	Peri-implant marginal bone level changes		12 months
Secondary	Number of technical complications		12 months
Secondary	Number of mechanical complications		12 months
Secondary	Number of Biological complications		12 months