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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Spain

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.

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 groups in NCT07323290
Study groupRoleWhat they receive
Maxilla group25 full-arch zirconia prostheses
Receives: Other: No intervention
Mandible group24 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted7 Jan 2026
  2. Study start15 Dec 2024
  3. Primary completion1 Dec 2025
  4. Study completion10 Dec 2025

Resources

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
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 26498998
  • Riera 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 38415804
  • Waltenberger 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 40802222
  • Todaro 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 38338217
  • Garza 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

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.

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