Intraoral vs Extraoral Cementation of Zirconia Bridges on Ti-Bases: Microstrain Evaluation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years old) in good general health.
Presence of an edentulous space requiring rehabilitation with a three-unit implant-supported fixed bridge.
Presence of two already osseointegrated Essential Cone implants (Klockner) indicated for a three-unit implant-supported restoration in the edentulous area.
Ability and willingness to participate and attend study visits and follow-up.
Disqualifiers
ASA III or ASA IV.
Current or previous treatment with bisphosphonates.
Smoking >10 cigarettes/day.
Extraction in the study area <3 months before implant placement with incomplete healing.
Trial design
Design model
Crossover
Treatments tested in this trial
Extraoral cementation on Ti-bases
Procedure/SurgeryExtraoral (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.
Intraoral cementation on Ti-bases
Procedure/SurgeryIntraoral (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).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Extraoral cementation (laboratory)Active comparator 1 intervention
Group B: Intraoral cementation (chairside)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Peri-implant microstrain (µε) measured by strain gauges
Micro-deformation around implant replicas supporting a three-unit zirconia bridge on Ti-bases, recorded with bonded strain gauges and expressed as microstrain (µε). Measurements are obtained for both cementation techniques (extraoral vs intraoral) using the same standardized recording protocol. Measurements for the extraoral (control) restoration are recorded prior to delivery, and measurements for the intraoral (test) restoration are recorded approximately 1 week after chairside cementation once the restoration is received by the laboratory.
Time frame
Pre-delivery (laboratory assessment) and ~1 week after intraoral cementation (7 ± 3 days).Secondary outcomes
1
Difference in microstrain between techniques (paired within-case)
Within each case, the difference in microstrain (µε) between intraoral and extraoral cementation is calculated using paired measurements to assess the magnitude and direction of the effect. Measurements for the extraoral (control) restoration are recorded prior to delivery, and measurements for the intraoral (test) restoration are recorded approximately 1 week after chairside cementation once the restoration is received by the laboratory.
Time frame
Pre-delivery (laboratory assessment) and ~1 week after intraoral cementation (7 ± 3 days).Sponsors and contacts
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Source ClinicalTrials.gov
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