Biomechanical PhenomenaNCT07448701
Intraoral vs Extraoral Cementation of Zirconia Bridges on Ti-Bases: Microstrain Evaluation
A study testing Extraoral cementation on Ti-bases and Intraoral cementation on Ti-bases in people with Biomechanical Phenomena and Partial Edentulism, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biomechanical Phenomena, Partial Edentulism
- What is being tested?
- Extraoral cementation on Ti-bases and Intraoral cementation on Ti-bases
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Signed informed consent.
Who cannot join
- 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.
- Guided bone regeneration in the study area with <6 months of healing time.
- Signs of active periodontal disease (e.g., poor plaque control and/or bleeding on probing above acceptable levels).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Clínica Universitària d'Odontologia UIC Barcelona
Sant Cugat del Vallès, Barcelona, 08195
MARTA VALLES, Principal Investigator, +34 619747903, mvalles@uic.es
PATRICIA FREIRE, Sub Investigator, +34 686054668, patricia.freire@uic.es
About this study
Official title: Influence of Cementation Technique on Microstrain in Three-Unit Bridges on Ti-Bases Evaluated by Strain Gauges
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.
Read the 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
- Biomechanical Phenomena, Partial Edentulism
- Being tested
- Extraoral cementation on Ti-bases, Intraoral cementation on Ti-bases
- Keywords
- titanium base, ti-base, zirconia bridge, intraoral cementation, passive fit, screw-retained restoration, strain gauge, CAD/CAM zirconia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraoral cementation on Ti-basesProcedure or surgery
Extraoral (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-basesProcedure or surgery
Intraoral (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).
| Study group | Role | What they receive |
|---|---|---|
| Extraoral cementation (laboratory) | Active comparator | Three-unit zirconia bridge cemented to Ti-bases extraorally on the working model under standardized laboratory conditions. Strain-gauge evaluation is performed in the laboratory prior to prosthesis delivery. Receives: Procedure: Extraoral cementation on Ti-bases |
| Intraoral cementation (chairside) | Experimental | An identical three-unit zirconia bridge is cemented to Ti-bases intraorally following a standardized chairside protocol. The assembly is then removed and sent to the laboratory. Strain-gauge evaluation is performed approximately 1 week after intraoral cementation (7 ± 3 days). Receives: Procedure: Intraoral cementation on Ti-bases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-delivery (laboratory assessment) and ~1 week after intraoral cementation (7 ± 3 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomechanical PhenomenaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Within-case paired comparison: for each enrolled clinical case, two identical zirconia bridges are fabricated. One is cemented extraorally to Ti-bases (control) and an identical replica is cemented intraorally (test). Microstrain is measured for both conditions using the same protocol, allowing a paired analysis within each case.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Vallés Rodríguez, Universitat Internacional de Catalunya
- Investigators
- MARTA VALLES, DDS, PhD, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448701
- Sponsor's protocol ID
- REST-ECL-2025-06
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because this is a single-center academic study with a small sample size, and the dataset includes detailed case-level clinical and technical measurements. We will report the results in aggregate form in publications.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cementation Technique on Microstrain in Three-Unit Bridges on Ti-Bases Evaluated by Strain Gauges
- ClinicalTrials.gov ID
- NCT07448701
- Acronym / sponsor ID
- REST-ECL-2025-06
- Conditions
- Biomechanical Phenomena, Partial Edentulism
- Keywords
- titanium base, ti-base, zirconia bridge, intraoral cementation, passive fit, screw-retained restoration, strain gauge, CAD/CAM zirconia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Mar 2026 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within-case paired comparison: for each enrolled clinical case, two identical zirconia bridges are fabricated. One is cemented extraorally to Ti-bases (control) and an identical replica is cemented intraorally (test). Microstrain is measured for both conditions using the same protocol, allowing a paired analysis within each case.
| Arm | Type | Receives |
|---|---|---|
| Extraoral cementation (laboratory) | Active comparator | Procedure: Extraoral cementation on Ti-basesThree-unit zirconia bridge cemented to Ti-bases extraorally on the working model under standardized laboratory conditions. Strain-gauge evaluation is performed in the laboratory prior to prosthesis delivery. |
| Intraoral cementation (chairside) | Experimental | Procedure: Intraoral cementation on Ti-basesAn identical three-unit zirconia bridge is cemented to Ti-bases intraorally following a standardized chairside protocol. The assembly is then removed and sent to the laboratory. Strain-gauge evaluation is performed approximately 1 week after intraoral cementation (7 ± 3 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Signed informed consent.
Key exclusion criteria (6 listed)
- 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.
- Guided bone regeneration in the study area with <6 months of healing time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extraoral 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. | Procedure or surgery | Extraoral cementation (laboratory) |
| Intraoral 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). | Procedure or surgery | Intraoral cementation (chairside) |
Primary outcome
Peri-implant microstrain (µε) measured by strain gauges
Time frame: Pre-delivery (laboratory assessment) and ~1 week after intraoral cementation (7 ± 3 days).
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.
1 secondary outcome
Difference in microstrain between techniques (paired within-case)
Time frame: Pre-delivery (laboratory assessment) and ~1 week after intraoral cementation (7 ± 3 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No. IPD will not be shared because this is a single-center academic study with a small sample size, and the dataset includes detailed case-level clinical and technical measurements. We will report the results in aggregate form in publications.
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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.
MARTA VALLES, DDS, PhD principal investigator
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraoral cementation on Ti-bases and Intraoral cementation on Ti-bases in people with Biomechanical Phenomena and Partial Edentulism, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Mar 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARTA VALLES, DDS, PhD (+34 619747903, mvalles@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant microstrain (µε) measured by strain gauges (time frame: Pre-delivery (laboratory assessment) and ~1 week after intraoral cementation (7 ± 3 days).). 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 4 Mar 2026.