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Completed

NCT Number: NCT07323290

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitat internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This is an observational study. No experimental intervention is assigned. All treatments were performed as part of routine clinical care.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

Twelve-Month Short-Term Marginal Bone Remodeling at Monolithic Zirconia Full-Arch Prostheses in the Maxilla and Mandible: A Clinical Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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