NCT07323290

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 10, 2025

Last Update Submit

December 28, 2025

Conditions

EdentulismImplant Dentistry

Keywords

Monolithic zirconiaV-shaped mandibleU-shaped mandibleMandibular morphologyBone remodeling

Outcome Measures

Primary Outcomes (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).

    Baseline and 12 months

Secondary Outcomes (4)

  • Implant and Prosthetic Survival Rate

    Baseline to 12 months

  • Patient-Reported Outcomes (OHIP-14)

    Baseline and 12 months

  • Patient-Reported Outcomes (Visual Analog Scale)

    Baseline and 12 months

  • Mechanical and Biological Complications

    Baseline to 12 months

Study Arms (2)

Maxilla group

25 full-arch zirconia prostheses

Other: No intervention

Mandible group

24 full-arch zirconia prostheses

Other: No intervention

Interventions

No interventionOTHER

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

Mandible groupMaxilla group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Related Publications (5)

  • 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.

    PMID: 26498998BACKGROUND

  • 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.

    PMID: 38415804BACKGROUND

  • 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.

    PMID: 40802222BACKGROUND

  • 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.

    PMID: 38338217BACKGROUND

  • 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.

    PMID: 39942227BACKGROUND

Study Officials

  • Miguel Roig, Phd

    Universitat Internacional de Catalunya

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Restorative Dentistry

Study Record Dates

First Submitted

December 10, 2025

First Posted

January 7, 2026

Study Start

December 15, 2024

Primary Completion

December 1, 2025

Study Completion

December 10, 2025

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

All data will be published

Locations

ES(1)