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Not Yet RecruitingNCT07448701

Intraoral vs Extraoral Cementation of Zirconia Bridges on Ti-Bases: Microstrain Evaluation

Influence of Cementation Technique on Microstrain in Three-Unit Bridges on Ti-Bases Evaluated by Strain Gauges

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Universitat Internacional de Catalunya · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This prospective clinical study compares two cementation techniques for implant-supported zirconia fixed partial dentures on titanium bases (Ti-bases): extraoral cementation performed on the working model and intraoral cementation performed chairside. Thirty clinical cases with two osseointegrated implants requiring a multi-unit zirconia restoration will be recruited at the UIC Dental Clinic. For each case, two restorations with identical design will be produced: one will be cemented extraorally (control) and an identical replica will be cemented intraorally (test). Micro-deformation will be assessed as peri-implant microstrain (µε) using a standardized strain-gauge setup and the same recording protocol for both techniques. The primary analysis compares microstrain between intraoral and extraoral cementation within each case; implant/prosthetic events will be recorded descriptively.

Detailed description

This study will evaluate whether the cementation approach of zirconia restorations onto Ti-bases influences peri-implant strain. Two clinical workflows are compared: (1) extraoral cementation of the zirconia restoration to Ti-bases on the working model prior to delivery, and (2) intraoral chairside cementation of an equivalent restoration to Ti-bases using the same intended clinical seating conditions. For each enrolled case, two restorations with the same design will be fabricated so that both cementation approaches can be assessed within the same case. After cementation, restorations will be evaluated using a standardized strain-gauge measurement setup on a model reproducing the clinical implant relationship, applying the same torque and recording procedure for both techniques. All clinical procedures will be performed at the UIC Dental Clinic, and strain-gauge recordings will be performed at the collaborating center (Universidad Europea Miguel de Cervantes, UEMC) following a consistent protocol. Data will be handled using study codes, and only study-coded technical files will be shared with the collaborating center.

Conditions

Interventions

TypeNameDescription
PROCEDUREExtraoral cementation on Ti-basesExtraoral (laboratory) cementation of a three-unit zirconia bridge to Ti-bases on the working model using a standardized protocol, with strain-gauge evaluation performed prior to prosthesis delivery.
PROCEDUREIntraoral cementation on Ti-basesIntraoral (chairside) cementation of an identical three-unit zirconia bridge to Ti-bases following a standardized protocol. The assembly is removed and sent to the laboratory, where strain-gauge evaluation is performed approximately 1 week later (7 ± 3 days).

Timeline

Start date
2026-03-01
Primary completion
2027-03-01
Completion
2027-06-01
First posted
2026-03-04
Last updated
2026-03-04

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07448701. Inclusion in this directory is not an endorsement.