NCT07235072

Brief Summary

compare the passive fit of three impression techniques: photogrammetry, intraoral digital scanning with splinted scan bodies, and the conventional open-tray impression technique, within the context of the All-on-X treatment concept. This comparison is expected to provide valuable clinical evidence to support clinicians in making informed decisions when considering the adoption of digital alternatives to conventional methods.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress50%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

November 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 14, 2025

Last Update Submit

November 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Passive fit measured using 3D inspection software (Geomagic Control X)

    Immediately after framework verification

Secondary Outcomes (1)

  • Time efficiency, assessed using stop watch and measured by seconds.

    During impression procedure

Study Arms (3)

Photogrammetry-Based Full-Arch Impression

EXPERIMENTAL
Device: Photogrammetry-Based Full-Arch Impression

Digital Impression Using Splinted Scan Bodies

EXPERIMENTAL
Device: Digital Impression Using Splinted Scan Bodies

Conventional Open-Tray Implant Impression

ACTIVE COMPARATOR
Procedure: Conventional Open-Tray Implant Impression

Interventions

Use of a photogrammetry system to capture the positions of All-on-X implants digitally without physical impression materials. The technique aims to achieve precise passive fit and reduce chairside working time. Measurements of passive fit discrepancy and total procedure time will be recorded

Photogrammetry-Based Full-Arch Impression

Digital full-arch impression using splinted scan bodies connected with resin to enhance stability. An intraoral scanner captures the splinted assembly for framework fabrication. Passive fit and working time will be evaluated

Digital Impression Using Splinted Scan Bodies

Traditional full-arch open-tray impression using polyether or VPS material with splinted impression copings. This serves as the standard comparator for evaluating passive fit and procedure duration

Conventional Open-Tray Implant Impression

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 45-65 years.
  • Fully edentulous or partially edentulous maxilla requiring full-arch rehabilitation.
  • Sufficient maxillary bone volume to support at least four implants according to the All-on-X protocol.
  • Systemically healthy patients with no contraindications to dental implant surgery (ASA I-II classification).
  • Demonstrated ability to maintain adequate oral hygiene.
  • Willingness to participate in the study and comply with follow-up visits and required maintenance protocols.
  • Patients seeking a fixed, implant-supported prosthesis for the maxilla due to missing teeth and inability to use removable prostheses effectively.
  • Acceptable radiographic findings with no signs of pathology, infection, or significant anatomical limitations.

You may not qualify if:

  • Uncontrolled systemic diseases (e.g., uncontrolled diabetes, osteoporosis, immunosuppressive disorders)
  • History of radiation therapy to the head and neck region
  • Active periodontal disease or untreated caries
  • Maxillary cysts, tumors, or pathologies
  • Poor oral hygiene or inability to maintain postoperative care
  • Insufficient bone volume for All-on-X without extensive grafting
  • Maxillary sinus pathology or oroantral fistula
  • Psychiatric illness or cognitive impairment affecting compliance
  • Bruxism or parafunctional habits
  • Pregnant or lactating women
  • History of implant failure or titanium allergy
  • Use of bisphosphonates or antiresorptive medications
  • Heavy smoking (\>10 cigarettes/day)
  • Inability or unwillingness to attend follow-up visits
  • Diagnosed or symptomatic temporomandibular joint disorders (pain, clicking, locking, limited opening)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Jasim AG, Abo Elezz MG, Altonbary GY, Elsyad MA. Accuracy of digital and conventional implant-level impression techniques for maxillary full-arch screw-retained prosthesis: A crossover randomized trial. Clin Implant Dent Relat Res. 2024 Aug;26(4):714-723. doi: 10.1111/cid.13336. Epub 2024 May 10.

  • Papaspyridakos P, De Souza A, Finkelman M, Sicilia E, Gotsis S, Chen YW, Vazouras K, Chochlidakis K. Digital vs Conventional Full-Arch Implant Impressions: A Retrospective Analysis of 36 Edentulous Jaws. J Prosthodont. 2023 Apr;32(4):325-330. doi: 10.1111/jopr.13536. Epub 2022 May 31.

  • Drancourt N, Auduc C, Mouget A, Mouminoux J, Auroy P, Veyrune JL, El Osta N, Nicolas E. Accuracy of Conventional and Digital Impressions for Full-Arch Implant-Supported Prostheses: An In Vitro Study. J Pers Med. 2023 May 15;13(5):832. doi: 10.3390/jpm13050832.

Central Study Contacts

Mohammed Fathy Ghobashy, Bachelor of Dental Surgery

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Candidate , Prosthodontics Department, October 6 University

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 19, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE