Marginal Bone Remodeling at Monolithic Zirconia Full-Arch Prostheses in the Maxilla and Mandible

December 28, 2025 updated by: Luis Carlos Garza Garza, Universitat Internacional de Catalunya

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Universitat Internacional de Catalunya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Edentulous adults undergoing full-arch rehabilitation with monolithic zirconia prostheses at the Universitat Internacional de Catalunya and associated private practice centers.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Bruxism
  • Uncontrolled systemic diseases
  • Bisphosphonate therapy
  • Contraindications to dental implant surgery
  • Active oral pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Maxilla group
25 full-arch zirconia prostheses
Other: No intervention
This is an observational study. No experimental intervention is assigned. All treatments were performed as part of routine clinical care.
Mandible group
24 full-arch zirconia prostheses
Other: No intervention
This is an observational study. No experimental intervention is assigned. All treatments were performed as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant and Prosthetic Survival Rate
Time Frame: Baseline to 12 months

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.
Baseline to 12 months
Patient-Reported Outcomes (OHIP-14)
Time Frame: Baseline and 12 months

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.
Baseline and 12 months
Patient-Reported Outcomes (Visual Analog Scale)
Time Frame: Baseline and 12 months

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.
Baseline and 12 months
Mechanical and Biological Complications
Time Frame: Baseline to 12 months

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.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Investigators

  • Study Director: Miguel Roig, Phd, Universitat Internacional de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2024

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 10, 2025

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REST-ECL-202002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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