NCT07550725

Brief Summary

This study aims to compare the trueness and precision of three impression methodologies photogrammetry, digital intraoral scanning with splinted scan bodies, and conventional open tray impressions in the context of the All-on-X treatment concept. This will provide valuable evidence for clinicians considering digital workflows for implant-supported prostheses. Does the use of photogrammetry and digital impression techniques with splinted scan bodies result in improved accuracy in implant position transfer in the All-on-X concept compared to conventional open tray impressions?

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
May 2026Oct 2026

First Submitted

Initial submission to the registry

February 14, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 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

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

February 14, 2026

Last Update Submit

May 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy measured using 3D inspection software (Geomagic Control X).

    Immediately after measurements taking

Secondary Outcomes (1)

  • Oral health-related quality of life (OHRQoL), assessed using standardized questionnaires.

    immediately after measurements taking

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 photogrammetry system to capture the positions of All on X implants digitally without physical impression material. This technique aims to achieve precise measurements and increase patient satisfaction

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. Accuracy and patient satisfaction 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 accuracy and patient satisfaction.

conventional open tray implant impression

Eligibility Criteria

Age55 Years - 65 Years
Sexmale(Gender-based eligibility)
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

Study Sites (1)

October 6 University

Giza, Egypt

Location

Related Publications (1)

  • Drancourt, N., Auduc, C., Mouget, A., Mouminoux, J., Auroy, P., Veyrune, J. L., El Osta, N., & Nicolas, E. (2023). Accuracy of Conventional and Digital Impressions for Full-Arch Implant-Supported Prostheses: An In Vitro Study. Journal of personalized medicine, 13(5), 832.

    BACKGROUND

Central Study Contacts

hadeer Ali, teaching assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

February 14, 2026

First Posted

April 24, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

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

Locations