Passive Fit and Time Efficiency in All On-X Implants Protocols Using Photogrammetry, Splinted Scan Bodies, and Conventional Impression Technique

NCT ID: NCT07235072

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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For edentulous patients undergoing full-arch rehabilitation, the All-on-X treatment approach has proven to be a very successful option, providing enhanced function, aesthetics, and patient satisfaction. Achieving passive fit, which reduces mechanical stress on implants and prosthetic components and reduces the possibility of problems such screw loosening, fracture, or marginal bone loss, is crucial to the long-term effectiveness of implant-supported prostheses. Passive fit has traditionally been evaluated after prostheses are fabricated using traditional open-tray impression techniques, which are regarded as the gold standard because of their great precision and dependability. These approaches, however, are challenging, technique-specific, and susceptible to human mistake or material deformation. Other methods include digital intraoral scanning with splinted scan bodies and photogrammetry have become more appreciated due to the quick development of digital dentistry. Potential advantages of these digital workflows include quicker digital data transfer to the lab, less chairside time, and improved patient comfort. In the context of the All-on-X procedure, there is still no clinical data comparing the accuracy especially passive fit and time efficiency of these more recent methods with traditional impressions, despite these benefits. Thus, the purpose of this study is to compare the time efficiency and passive fit of three impression techniques: traditional open-tray impressions, digital intraoral scanning with splinted scan bodies, and photogrammetry. The findings will provide clinicians with evidence-based insights into whether digital alternatives can match or surpass traditional techniques in terms of accuracy and workflow efficiency, ultimately supporting the transition toward more modern, streamlined protocols in implant prosthodontics.

Conditions

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Passive Fit of Full-arch Implant Prostheses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Photogrammetry-Based Full-Arch Impression

Group Type EXPERIMENTAL

Photogrammetry-Based Full-Arch Impression

Intervention Type DEVICE

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

Digital Impression Using Splinted Scan Bodies

Group Type EXPERIMENTAL

Digital Impression Using Splinted Scan Bodies

Intervention Type DEVICE

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

Conventional Open-Tray Implant Impression

Group Type ACTIVE_COMPARATOR

Conventional Open-Tray Implant Impression

Intervention Type PROCEDURE

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

Interventions

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Photogrammetry-Based Full-Arch Impression

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

Intervention Type DEVICE

Digital Impression Using Splinted Scan Bodies

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

Intervention Type DEVICE

Conventional Open-Tray Implant Impression

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Fathy Abdelhamid

Master's Degree Candidate , Prosthodontics Department, October 6 University

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohammed Fathy Ghobashy, Bachelor of Dental Surgery

Role: CONTACT

00201099632823

References

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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.

Reference Type RESULT
PMID: 38727015 (View on PubMed)

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.

Reference Type RESULT
PMID: 35524647 (View on PubMed)

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.

Reference Type RESULT
PMID: 37241002 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RECO6U/22-2025

Identifier Type: -

Identifier Source: org_study_id

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