Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07353619

All-on-X Stackable Guides for Maxillary Terminal Dentition

All-on-X (Full-arch Implant-supported Rehabilitation) Stackable Surgical Guides for Maxillary Terminal Dentition: a 2-year Retrospective Analysis

Status
Recruiting
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Menoufia University · Academic / Other
Sex
All
Age
40 Years – 70 Years
Healthy volunteers

Summary

This retrospective study will evaluate the clinical performance of maxillary All-on-X(full-arch implant-supported rehabilitation) implant rehabilitation using stackable guided surgery and immediate loading. Implant survival and peri-implant outcomes will be assessed over a 2-year follow-up, with regression analysis will be used to investigate the influence of surgical and prosthetic variables, including basal seating guide design.

Detailed description

This study is a retrospective analysis of data derived from a prospectively maintained clinical database evaluating the clinical performance of maxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery protocol with immediate loading. Consecutive patients presenting with terminal maxillary dentition were treated with a maxillary All-on-6 implant-supported complete fixed dental prosthesis (ISCFDP) using a prosthetically driven digital workflow. Implant planning was performed using three-dimensional imaging and dedicated implant planning software, allowing for virtual determination of implant number, position, angulation, and depth in relation to the planned prosthesis. Stackable surgical guides were designed and fabricated to allow guided bone reduction when indicated, followed by fully guided implant placement. All implants were placed under local anesthesia using a standardized surgical protocol. Implants achieving a minimum insertion torque of 35 Ncm were immediately loaded with a screw-retained provisional fixed prosthesis on multi-unit abutments. Occlusal contacts were minimized during the healing phase to reduce functional loading. Patients were followed according to a predefined clinical and radiographic follow-up schedule for a minimum period of two years. The primary outcome of the study will be implant survival at 6 months after placement. Secondary outcomes will include peri-implant clinical parameters (plaque index, bleeding on probing, and probing depth), marginal bone level changes which will be assessed on standardized periapical radiographs at prosthesis delivery, 1-year, and 2-year follow-up visits, and implant success according to established criteria.

Conditions

Interventions

TypeNameDescription
OTHERMaxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery workflow with immediate loading.Patients underwent maxillary full-arch implant rehabilitation using an All-on-X concept performed with a fully digital stackable guided surgery workflow and an immediate loading protocol. Implant placement was planned prosthetically using three-dimensional imaging and digital planning software. Stackable surgical guides were used to facilitate guided bone reduction when indicated and fully guided implant placement. Six implants were placed in the maxillary arch under local anesthesia following a standardized surgical protocol. Implants achieving adequate primary stability were immediately restored with a screw-retained provisional fixed prosthesis supported by multi-unit abutments. Patients were followed according to a predefined clinical and radiographic protocol for outcome assessment.

Timeline

Start date
2024-01-01
Primary completion
2026-03-01
Completion
2026-05-01
First posted
2026-01-20
Last updated
2026-01-20

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07353619. Inclusion in this directory is not an endorsement.