- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07235072
Passive Fit and Time Efficiency in All On-X Implants Protocols Using Photogrammetry, Splinted Scan Bodies, and Conventional Impression Technique
Comparative Analysis of Passive Fit and Time Efficiency in Allon-X Implants Protocols Using Photogrammetry, Splinted Scan Bodies, and Conventional Impression Technique
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammed Fathy Ghobashy, Bachelor of Dental Surgery
- Phone Number: 00201099632823
- Email: mo97.fathy@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-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 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
|
|
Experimental: 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
|
|
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 passive fit and procedure duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Passive fit measured using 3D inspection software (Geomagic Control X)
Time Frame: Immediately after framework verification
|
Immediately after framework verification
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time efficiency, assessed using stop watch and measured by seconds.
Time Frame: During impression procedure
|
During impression procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RECO6U/22-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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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