EdentulismNCT07323290
Marginal Bone Remodeling at Monolithic Zirconia Full-Arch Prostheses in the Maxilla and Mandible
An observational study of Edentulism and Implant Dentistry, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
This prospective observational clinical study aims to compare 12-month clinical, radiographic, and patient-reported outcomes of monolithic zirconia full-arch implant-supported prostheses placed in the maxilla versus the mandible. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulism, Implant Dentistry
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2024to 10 Dec 2025
- How long will I take part?
- 12 Months
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Edentulous adults undergoing full-arch rehabilitation with monolithic zirconia prostheses at the Universitat Internacional de Catalunya and associated private practice centers.
Who may be able to join
- Adults ≥ 50 years old
- Edentulous maxilla or mandible
- Sufficient bone volume for implant placement
- Non-smokers or light smokers (<10 cigarettes/day)
- Able to provide informed consent
Who cannot join
- Bruxism
- Uncontrolled systemic diseases
- Bisphosphonate therapy
- Contraindications to dental implant surgery
- Active oral pathology
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Official title: Twelve-Month Short-Term Marginal Bone Remodeling at Monolithic Zirconia Full-Arch Prostheses in the Maxilla and Mandible: A Clinical Study
This prospective observational clinical study aims to compare 12-month clinical, radiographic, and patient-reported outcomes of monolithic zirconia full-arch implant-supported prostheses placed in the maxilla versus the mandible. The study also investigates whether mandibular morphology (U-shaped vs V-shaped) and arch geometry (inter-implant distance and cantilever length) are associated with early marginal bone remodeling. All arches were rehabilitated following standardized surgical and digital prosthetic protocols.
Read the detailed description
This prospective observational cohort study investigates early marginal bone remodeling in full-arch implant-supported monolithic zirconia prostheses placed in the maxilla and mandible. Although monolithic zirconia has become a widely adopted restorative material due to its mechanical strength, esthetic stability, and reduced risk of veneering complications, limited evidence exists regarding whether early bone remodeling differs between the maxillary and mandibular arches or whether mandibular anatomical configurations influence these remodeling patterns. The present study was designed to address these knowledge gaps under rigorously standardized surgical and prosthetic conditions.
All participants were fully edentulous and rehabilitated following identical clinical protocols. Each arch received between six and eight titanium implants placed through computer-guided surgery, followed by the connection of multi-unit abutments and the delivery of an immediate-loading PMMA provisional prosthesis within 48 hours. After a healing period of three months, definitive monolithic zirconia full-arch prostheses were fabricated and delivered using a fully digital workflow. Standardized periapical radiographs were obtained at baseline (prosthesis insertion) and at the 12-month follow-up using customized positioning devices, fixed exposure parameters, and a paralleling technique to ensure reproducibility. Radiographs were calibrated digitally using the known implant thread pitch, and marginal bone level changes were measured by two independent calibrated examiners.
A key component of this study is the incorporation of mandibular anatomical variability into the analysis. Mandibular morphology was categorized into U-shaped and V-shaped configurations according to validated CBCT criteria based on intercanine-to-intermolar width ratios and anterior arch angles. Because mandibular flexure and strain distribution have been hypothesized to vary according to arch shape, the study evaluates whether these morphological classifications correspond to differences in early marginal bone remodeling. Additionally, geometric variables-including inter-implant distance and distal cantilever length-were extracted directly from the definitive CAD designs to assess potential associations between implant distribution and remodeling outcomes.
The study also incorporates patient-reported outcomes to better understand the functional and psychosocial impact of treatment. The OHIP-14 questionnaire and a visual analog scale (VAS) for satisfaction were administered at baseline and at the 12-month recall appointment. Clinical parameters, prosthetic complications, and peri-implant soft-tissue conditions were documented to complement the radiographic evaluation.
This design allows for multiple levels of comparison:
- Arch-level comparison (maxilla vs mandible) under identical surgical/prosthetic protocols.
- Morphology-specific analysis within the mandible (U-shaped vs V-shaped).
- Geometry-based evaluation assessing correlations between implant positioning (inter-implant distance, cantilever length) and marginal bone remodeling.
- Within-subject comparison for individuals rehabilitated in both arches.
Because the study is observational and non-interventional, it does not assign treatments or modify clinical protocols. Instead, it seeks to characterize natural remodeling patterns under contemporary full-arch zirconia rehabilitation techniques and to explore whether anatomical and geometric factors contribute to variability in early outcomes.
The broader goal of this research is to clarify whether certain mandibular anatomical configurations may benefit from modified implant distribution, segmented framework designs, or alternative prosthetic considerations. The findings have the potential to inform future guidelines in digital full-arch implant rehabilitation and help clinicians better anticipate patient-specific biomechanical challenges. Long-term follow-up and biomechanical measurements are encouraged for future studies to validate the associations observed in this 12-month analysis.
- Conditions
- Edentulism, Implant Dentistry
- Being tested
- No intervention
- Keywords
- Monolithic zirconia, V-shaped mandible, U-shaped mandible, Mandibular morphology, Bone remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study. No experimental intervention is assigned. All treatments were performed as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Maxilla group | 25 full-arch zirconia prostheses Receives: Other: No intervention | |
| Mandible group | 24 full-arch zirconia prostheses Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss (mm)
Marginal bone loss will be measured as the change in peri-implant marginal bone level (in millimeters) between baseline (prosthesis delivery) and the 12-month follow-up. Measurements will be obtained from standardized periapical radiographs using a paralleling technique and calibrated based on implant thread pitch.
Higher values indicate greater bone loss (worse outcome).
Measured: Baseline and 12 months
Secondary outcomes (4)
Implant and Prosthetic Survival Rate
Survival rate will be defined as the percentage of implants and prostheses remaining functional without loss, fracture, removal, or need for replacement.
An implant or prosthesis is considered a failure if it requires removal, becomes fractured, or cannot maintain clinical function.
Higher percentages indicate better survival outcomes.
Measured: Baseline to 12 months
Patient-Reported Outcomes (OHIP-14)
Patient-reported oral health-related quality of life will be assessed using the OHIP-14 questionnaire, scored from 0 to 56, where:
Higher scores indicate worse quality of life.
Measured: Baseline and 12 months
Patient-Reported Outcomes (Visual Analog Scale)
Satisfaction will be measured using a Visual Analog Scale (VAS) from 0 to 10, where:
0 = Not satisfied at all
10 = Extremely satisfied
Higher scores indicate greater satisfaction.
Changes between baseline and 12 months will be reported.
Measured: Baseline and 12 months
Mechanical and Biological Complications
Complications will include mechanical events (e.g., chipping, framework fracture, screw loosening) and biological events (e.g., soft-tissue inflammation, infection).
Each event will be recorded as present (yes/no) and categorized according to type.
Higher counts indicate worse outcomes.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Dec 2024
- Primary completion1 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Carlos Garza Garza, Universitat Internacional de Catalunya
- Investigators
- Miguel Roig, Phd, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323290
- Sponsor's protocol ID
- REST-ECL-202002
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be published
Publications
Sivaraman K, Chopra A, Venkatesh SB. Clinical importance of median mandibular flexure in oral rehabilitation: a review. J Oral Rehabil. 2016 Mar;43(3):215-25. doi: 10.1111/joor.12361. Epub 2015 Oct 25.
PubMed 26498998Riera C, Karasan D, Sailer I, Mojon P, Fehmer V, Pitta J. Mechanical stability of posterior implant-supported monolithic zirconia cantilever on titanium-base abutments. An in vitro study. Clin Oral Implants Res. 2024 Aug;35(8):1042-1053. doi: 10.1111/clr.14251. Epub 2024 Feb 28.
PubMed 38415804Waltenberger L, Bishti S, Wolfart S. German S3 guideline on implant-supported all-ceramic restorations. Int J Implant Dent. 2025 Aug 13;11(1):53. doi: 10.1186/s40729-025-00641-7.
PubMed 40802222Todaro C, Cerri M, Rodriguez Y Baena R, Lupi SM. Lower Jaw Full-Arch Restoration: A Completely Digital Approach to Immediate Load. Healthcare (Basel). 2024 Jan 28;12(3):332. doi: 10.3390/healthcare12030332.
PubMed 38338217Garza LC, Crooke E, Valles M, Soliva J, Rodriguez X, Rodeja M, Roig M. Evaluation of Polymethyl Methacrylate as a Provisional Material in a Fully Digital Workflow for Immediate-Load Complete-Arch Implant-Supported Prostheses over Three Months. Materials (Basel). 2025 Jan 26;18(3):562. doi: 10.3390/ma18030562.
PubMed 39942227
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve-Month Short-Term Marginal Bone Remodeling at Monolithic Zirconia Full-Arch Prostheses in the Maxilla and Mandible: A Clinical Study
- ClinicalTrials.gov ID
- NCT07323290
- Acronym / sponsor ID
- REST-ECL-202002
- Conditions
- Edentulism, Implant Dentistry
- Keywords
- Monolithic zirconia, V-shaped mandible, U-shaped mandible, Mandibular morphology, Bone remodeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 7 Jan 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 observational clinical study aims to compare 12-month clinical, radiographic, and patient-reported outcomes of monolithic zirconia full-arch implant-supported prostheses placed in the maxilla versus the mandible. The study also investigates whether mandibular morphology (U-shaped vs V-shaped) and arch geometry (inter-implant distance and cantilever length) are associated with early marginal bone remodeling. All arches were rehabilitated following standardized surgical and digital prosthetic protocols.
Detailed description
This prospective observational cohort study investigates early marginal bone remodeling in full-arch implant-supported monolithic zirconia prostheses placed in the maxilla and mandible. Although monolithic zirconia has become a widely adopted restorative material due to its mechanical strength, esthetic stability, and reduced risk of veneering complications, limited evidence exists regarding whether early bone remodeling differs between the maxillary and mandibular arches or whether mandibular anatomical configurations influence these remodeling patterns. The present study was designed to address these knowledge gaps under rigorously standardized surgical and prosthetic conditions.
All participants were fully edentulous and rehabilitated following identical clinical protocols. Each arch received between six and eight titanium implants placed through computer-guided surgery, followed by the connection of multi-unit abutments and the delivery of an immediate-loading PMMA provisional prosthesis within 48 hours. After a healing period of three months, definitive monolithic zirconia full-arch prostheses were fabricated and delivered using a fully digital workflow. Standardized periapical radiographs were obtained at baseline (prosthesis insertion) and at the 12-month follow-up using customized positioning devices, fixed exposure parameters, and a paralleling technique to ensure reproducibility. Radiographs were calibrated digitally using the known implant thread pitch, and marginal bone level changes were measured by two independent calibrated examiners.
A key component of this study is the incorporation of mandibular anatomical variability into the analysis. Mandibular morphology was categorized into U-shaped and V-shaped configurations according to validated CBCT criteria based on intercanine-to-intermolar width ratios and anterior arch angles. Because mandibular flexure and strain distribution have been hypothesized to vary according to arch shape, the study evaluates whether these morphological classifications correspond to differences in early marginal bone remodeling. Additionally, geometric variables-including inter-implant distance and distal cantilever length-were extracted directly from the definitive CAD designs to assess potential associations between implant distribution and remodeling outcomes.
The study also incorporates patient-reported outcomes to better understand the functional and psychosocial impact of treatment. The OHIP-14 questionnaire and a visual analog scale (VAS) for satisfaction were administered at baseline and at the 12-month recall appointment. Clinical parameters, prosthetic complications, and peri-implant soft-tissue conditions were documented to complement the radiographic evaluation.
This design allows for multiple levels of comparison:
- Arch-level comparison (maxilla vs mandible) under identical surgical/prosthetic protocols.
- Morphology-specific analysis within the mandible (U-shaped vs V-shaped).
- Geometry-based evaluation assessing correlations between implant positioning (inter-implant distance, cantilever length) and marginal bone remodeling.
- Within-subject comparison for individuals rehabilitated in both arches.
Because the study is observational and non-interventional, it does not assign treatments or modify clinical protocols. Instead, it seeks to characterize natural remodeling patterns under contemporary full-arch zirconia rehabilitation techniques and to explore whether anatomical and geometric factors contribute to variability in early outcomes.
The broader goal of this research is to clarify whether certain mandibular anatomical configurations may benefit from modified implant distribution, segmented framework designs, or alternative prosthetic considerations. The findings have the potential to inform future guidelines in digital full-arch implant rehabilitation and help clinicians better anticipate patient-specific biomechanical challenges. Long-term follow-up and biomechanical measurements are encouraged for future studies to validate the associations observed in this 12-month analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxilla group | – | Other: No intervention25 full-arch zirconia prostheses |
| Mandible group | – | Other: No intervention24 full-arch zirconia prostheses |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Edentulous adults undergoing full-arch rehabilitation with monolithic zirconia prostheses at the Universitat Internacional de Catalunya and associated private practice centers.
Key inclusion criteria (5 listed)
- Adults ≥ 50 years old
- Edentulous maxilla or mandible
- Sufficient bone volume for implant placement
- Non-smokers or light smokers (<10 cigarettes/day)
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Bruxism
- Uncontrolled systemic diseases
- Bisphosphonate therapy
- Contraindications to dental implant surgery
- Active oral pathology
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 |
|---|---|---|
| No interventionThis is an observational study. No experimental intervention is assigned. All treatments were performed as part of routine clinical care. | Other | Mandible group, Maxilla group |
Primary outcome
Marginal Bone Loss (mm)
Time frame: Baseline and 12 months
Marginal bone loss will be measured as the change in peri-implant marginal bone level (in millimeters) between baseline (prosthesis delivery) and the 12-month follow-up. Measurements will be obtained from standardized periapical radiographs using a paralleling technique and calibrated based on implant thread pitch. Higher values indicate greater bone loss (worse outcome).
4 secondary outcomes
Implant and Prosthetic Survival Rate
Time frame: Baseline to 12 months
Patient-Reported Outcomes (OHIP-14)
Time frame: Baseline and 12 months
Patient-Reported Outcomes (Visual Analog Scale)
Time frame: Baseline and 12 months
Mechanical and Biological Complications
Time frame: Baseline to 12 months
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 7 Jan 2026.
- Background: PubMed 26498998Sivaraman K, Chopra A, Venkatesh SB. Clinical importance of median mandibular flexure in oral rehabilitation: a review. J Oral Rehabil. 2016 Mar;43(3):215-25. doi: 10.1111/joor.12361. Epub 2015 Oct 25.
- Background: PubMed 38415804Riera C, Karasan D, Sailer I, Mojon P, Fehmer V, Pitta J. Mechanical stability of posterior implant-supported monolithic zirconia cantilever on titanium-base abutments. An in vitro study. Clin Oral Implants Res. 2024 Aug;35(8):1042-1053. doi: 10.1111/clr.14251. Epub 2024 Feb 28.
- Background: PubMed 40802222Waltenberger L, Bishti S, Wolfart S. German S3 guideline on implant-supported all-ceramic restorations. Int J Implant Dent. 2025 Aug 13;11(1):53. doi: 10.1186/s40729-025-00641-7.
- Background: PubMed 38338217Todaro C, Cerri M, Rodriguez Y Baena R, Lupi SM. Lower Jaw Full-Arch Restoration: A Completely Digital Approach to Immediate Load. Healthcare (Basel). 2024 Jan 28;12(3):332. doi: 10.3390/healthcare12030332.
- Background: PubMed 39942227Garza LC, Crooke E, Valles M, Soliva J, Rodriguez X, Rodeja M, Roig M. Evaluation of Polymethyl Methacrylate as a Provisional Material in a Fully Digital Workflow for Immediate-Load Complete-Arch Implant-Supported Prostheses over Three Months. Materials (Basel). 2025 Jan 26;18(3):562. doi: 10.3390/ma18030562.
- Individual participant dataSharing planned: No. All data will be published
Related trials for Edentulism
Active, not recruiting
Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Tooth Loss, Edentulism
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
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.
Miguel Roig, Phd study director
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?
An observational study of Edentulism and Implant Dentistry, 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 5 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 7 Jan 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?
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?
Marginal Bone Loss (mm) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07323290, which also lists 5 linked publications.
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 7 Jan 2026.