All-on-X Stackable Guides for Maxillary Terminal Dentition

Official title

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

Overview

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.

Interventions

• Other Maxillary 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

Primary outcome measures

• Implant Survival Rate [Time frame: 6 months after implant placement]

Eligibility criteria

Inclusion criteria

Adult patients presenting with terminal dentition of the maxillary arch

Rehabilitation with a maxillary All-on-6 implant-supported complete fixed dental prosthesis

Treatment performed using a fully digital stackable guided surgery workflow

Immediate loading with a provisional fixed prosthesis

Availability of complete clinical and radiographic records

Minimum follow-up period of 2 years

Prosthetic design classified as (Fixed prosthesis) FP-1 or FP-2 according to Misch classification

Exclusion criteria

Uncontrolled systemic conditions contraindicating implant surgery

History of head and neck radiotherapy

Presence of untreated periodontal or peri-implant infection at the time of surgery

Incomplete or missing clinical or radiographic records

Cases requiring simultaneous bone grafting procedures

Severe maxillary atrophy (Cawood and Howell Class III-V)

Cases requiring FP-3 prosthetic design

Rehabilitation performed without guided surgery or without immediate loading

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Egypt · 1 center

• Faculty of Dentistry — Shibīn al Kawm

Identifiers

NCT: NCT07353619 · ADMNF-002026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗