- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550725
Truness of Full Arch Impressions in All on x Cases
May 2, 2026 updated by: Hadeer Ali, October 6 University
Trueness of Full-Arch Impressions Using Photogrammetry, Splinted Digital Scan Bodies Versus Conventional Open-Tray Techniques in the All-on-x Prosthesis
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?
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: hadeer Ali, teaching assistant
- Phone Number: 01143252442
- Email: hadeeralisoliman5@gmail.com
Study Locations
-
-
-
Giza, Egypt
- October 6 University
-
Contact:
- october 6 university university
- Phone Number: (+202)38362488
- Email: dent@o6u.edu.eg
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: photogrammetry based full-arch impression
|
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
|
|
Experimental: Digital impression using splinted scan bodies
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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.
|
|
Active Comparator: 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 accuracy and patient satisfaction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Accuracy measured using 3D inspection software (Geomagic Control X).
Time Frame: Immediately after measurements taking
|
Immediately after measurements taking
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Oral health-related quality of life (OHRQoL), assessed using standardized questionnaires.
Time Frame: immediately after measurements taking
|
immediately after measurements taking
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
February 14, 2026
First Submitted That Met QC Criteria
April 19, 2026
First Posted (Actual)
April 24, 2026
Study Record Updates
Last Update Posted (Actual)
May 7, 2026
Last Update Submitted That Met QC Criteria
May 2, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- RECO6u/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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