Passive Fit of Full-arch Implant ProsthesesNCT07235072
Passive Fit and Time Efficiency in All On-X Implants Protocols Using Photogrammetry, Splinted Scan Bodies, and Conventional Impression Technique
A study testing Photogrammetry-Based Full-Arch Impression, Digital Impression Using Splinted Scan Bodies and Conventional Open-Tray Implant Impression in people with Passive Fit of Full-arch Implant Prostheses, run by October 6 University.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Passive Fit of Full-arch Implant Prostheses
- What is being tested?
- Photogrammetry-Based Full-Arch Impression, Digital Impression Using Splinted Scan Bodies and Conventional Open-Tray Implant Impression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Analysis of Passive Fit and Time Efficiency in Allon-X Implants Protocols Using Photogrammetry, Splinted Scan Bodies, and Conventional Impression Technique
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.
Read the detailed description
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.
- Being tested
- Photogrammetry-Based Full-Arch Impression, Digital Impression Using Splinted Scan Bodies, Conventional Open-Tray Implant Impression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photogrammetry-Based Full-Arch ImpressionDevice
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 BodiesDevice
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 ImpressionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Photogrammetry-Based Full-Arch Impression | Experimental | Not described Receives: Device: Photogrammetry-Based Full-Arch Impression |
| Digital Impression Using Splinted Scan Bodies | Experimental | Not described Receives: Device: Digital Impression Using Splinted Scan Bodies |
| Conventional Open-Tray Implant Impression | Active comparator | Not described Receives: Procedure: Conventional Open-Tray Implant Impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive fit measured using 3D inspection software (Geomagic Control X)
Measured: Immediately after framework verification
Secondary outcomes (1)
Time efficiency, assessed using stop watch and measured by seconds.
Measured: During impression procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start13 Oct 2026 (estimated)
- Primary completion13 Oct 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Passive Fit of Full-arch Implant ProsthesesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Fathy Abdelhamid, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235072
- Sponsor's protocol ID
- RECO6U/22-2025
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 38727015Papaspyridakos 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.
PubMed 35524647Drancourt 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.
PubMed 37241002
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Passive Fit and Time Efficiency in Allon-X Implants Protocols Using Photogrammetry, Splinted Scan Bodies, and Conventional Impression Technique
- ClinicalTrials.gov ID
- NCT07235072
- Acronym / sponsor ID
- RECO6U/22-2025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 13 Oct 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photogrammetry-Based Full-Arch ImpressionUse 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 | Device | Photogrammetry-Based Full-Arch Impression |
| Digital Impression Using Splinted Scan BodiesDigital 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 | Device | Digital Impression Using Splinted Scan Bodies |
| Conventional Open-Tray Implant ImpressionTraditional 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 | Procedure or surgery | Conventional Open-Tray Implant Impression |
Primary outcome
Passive fit measured using 3D inspection software (Geomagic Control X)
Time frame: Immediately after framework verification
1 secondary outcome
Time efficiency, assessed using stop watch and measured by seconds.
Time frame: During impression procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Results publication: PubMed 38727015Jasim 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.
- Results publication: PubMed 35524647Papaspyridakos 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.
- Results publication: PubMed 37241002Drancourt 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Photogrammetry-Based Full-Arch Impression, Digital Impression Using Splinted Scan Bodies and Conventional Open-Tray Implant Impression in people with Passive Fit of Full-arch Implant Prostheses, run by October 6 University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Fathy Ghobashy, Bachelor of Dental Surgery (00201099632823, mo97.fathy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive fit measured using 3D inspection software (Geomagic Control X) (time frame: Immediately after framework verification). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07235072, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.