Dental ImplantsNCT07778199
Passive Fit of Implant-Supported Frameworks: Digital vs Conventional Impressions
A study testing IO-Connect Digital Impression, Reverse Scan Body Digital Impression and Conventional Splinted Impression in people with Dental Implants and Edentulous Jaw, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized crossover clinical trial compares the passivity of fit of complete-arch mandibular implant-supported frameworks fabricated using three impression techniques: a non-calibrated splinted digital scan body system (IO-Connect), a Reverse Scan Body (RSB) digital impression technique, and a conventional… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Dental Implants, Edentulous Jaw, Passive Fit
- What is being tested?
- IO-Connect Digital Impression, Reverse Scan Body Digital Impression and Conventional Splinted Impression
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2026to 25 Jan 2027
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous patients requiring full-arch implant-supported fixed prosthesis
- Age 35-70 years
- Adequate mandibular bone to place at least four implants without major grafting
- Ability to undergo digital scanning and radiographic evaluation
- Signed informed consent
Who cannot join
- Systemic conditions affecting healing (uncontrolled diabetes, immunosuppression)
- History of head/neck radiotherapy or bisphosphonate therapy
- Active oral infection or severe bruxism
- Strong gag reflex preventing accurate scanning
- Poor compliance or unwillingness to attend follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate
Ahmed H Hazem Elsayed Helmi Atwa, BDS, +20 1092758696, ahmedhazem@mans.edu.eg
Ahmed Hazem Elsayed Helmi Atwa, BDS
About this study
Official title: Passive Fit Evaluation of Full-Arch Implant-supported Frameworks Using Digital and Conventional Impression Techniques: Crossover Study
This randomized crossover clinical trial compares the passivity of fit of complete-arch mandibular implant-supported frameworks fabricated using three impression techniques: a non-calibrated splinted digital scan body system (IO-Connect), a Reverse Scan Body (RSB) digital impression technique, and a conventional splinted open-tray impression technique. Eight completely edentulous patients each receiving four mandibular implants will be included. Passivity of fit will be evaluated clinically using the Sheffield one-screw test and radiographically using intraoral periapical radiographs obtained with the parallel technique.
Read the detailed description
Full-arch implant-supported fixed prostheses require a high degree of passive fit to avoid mechanical and biological complications. While digital impression workflows are increasingly used as alternatives to conventional splinted impressions, evidence directly comparing their clinical accuracy for complete-arch implant frameworks remains limited, particularly for the IO-Connect non-calibrated splinting system and the Reverse Scan Body technique.
Eight completely edentulous patients with at least four mandibular implants will be enrolled. Using a crossover design, each patient will undergo all three impression techniques: Group I (IO-Connect splinted scan bodies), Group II (Reverse Scan Body technique), and Group III (conventional splinted open-tray impression with polyvinyl siloxane and Type IV stone casts). For each technique, a corresponding implant-supported framework will be fabricated and evaluated for passivity of fit using the Sheffield one-screw test and periapical radiographs taken with a paralleling device to assess microgaps at the implant-framework interface.
- Conditions
- Dental Implants, Edentulous Jaw, Passive Fit
- Being tested
- IO-Connect Digital Impression, Reverse Scan Body Digital Impression, Conventional Splinted Impression
- Keywords
- Passive fit, Implant-supported framework, Digital impression, Full-arch implant prosthesis, Crossover study
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IO-Connect Digital ImpressionProcedure or surgery
Digital impression of the mandibular arch obtained using IO-Connect non-calibrated splinted scan bodies to fabricate the implant-supported framework for Group I.
Reverse Scan Body Digital ImpressionProcedure or surgery
Digital impression obtained using the Reverse Scan Body (RSB) technique, involving extraoral scanning of scan bodies and superimposition with intraoral tissue scans, to fabricate the implant-supported framework for Group II.
Conventional Splinted ImpressionProcedure or surgery
Conventional splinted open-tray impression using polyvinyl siloxane material and Type IV dental stone to fabricate the implant-supported framework for Group III.
| Study group | Role | What they receive |
|---|---|---|
| Group I: IO-Connect | Active comparator | Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with IO-Connect non-calibrated splinted scan bodies. Receives: Procedure: IO-Connect Digital Impression |
| Group II: Reverse Scan Body | Active comparator | Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with the Reverse Scan Body (RSB) technique. Receives: Procedure: Reverse Scan Body Digital Impression |
| Group III: Conventional Impression | Active comparator | Patients received complete-arch implant-supported frameworks fabricated using a conventional splinted open-tray impression technique. Receives: Procedure: Conventional Splinted Impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive Fit Assessed by Sheffield One-Screw Test
The framework was seated on all implants and a single distal screw was fully tightened; remaining screw sites were examined visually and tactilely for lifting, rocking, or gaps as an indicator of passive fit.
Measured: The evaluation of passive fit by Sheffield one-screw test will be done 3 months after implant placement (3M-IP), at framework try-in for each of the three impression techniques.
Passive Fit Assessed by Periapical Radiographs
Intraoral periapical radiographs were obtained at each implant site using a paralleling device and evaluated for microgaps at the implant-framework interface.
Measured: The evaluation of passive fit by periapical radiographs will be done 3 months after implant placement, at framework try-in for each of the three impression techniques.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start25 Jan 2026
- Primary completion25 Oct 2026 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient will sequentially receive all three impression techniques (IO-Connect, Reverse Scan Body, and conventional splinted impression) for framework fabrication and passive fit evaluation.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hazem Elsayed Helmi, Mansoura University
- Investigators
- Fatma A El-Waseef, PhD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778199
- Sponsor's protocol ID
- MS.25-12-95
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Fit Evaluation of Full-Arch Implant-supported Frameworks Using Digital and Conventional Impression Techniques: Crossover Study
- ClinicalTrials.gov ID
- NCT07778199
- Acronym / sponsor ID
- MS.25-12-95
- Conditions
- Dental Implants, Edentulous Jaw, Passive Fit
- Keywords
- Passive fit, Implant-supported framework, Digital impression, Full-arch implant prosthesis, Crossover study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 21 Aug 2026 (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.
This randomized crossover clinical trial compares the passivity of fit of complete-arch mandibular implant-supported frameworks fabricated using three impression techniques: a non-calibrated splinted digital scan body system (IO-Connect), a Reverse Scan Body (RSB) digital impression technique, and a conventional splinted open-tray impression technique. Eight completely edentulous patients each receiving four mandibular implants will be included. Passivity of fit will be evaluated clinically using the Sheffield one-screw test and radiographically using intraoral periapical radiographs obtained with the parallel technique.
Detailed description
Full-arch implant-supported fixed prostheses require a high degree of passive fit to avoid mechanical and biological complications. While digital impression workflows are increasingly used as alternatives to conventional splinted impressions, evidence directly comparing their clinical accuracy for complete-arch implant frameworks remains limited, particularly for the IO-Connect non-calibrated splinting system and the Reverse Scan Body technique.
Eight completely edentulous patients with at least four mandibular implants will be enrolled. Using a crossover design, each patient will undergo all three impression techniques: Group I (IO-Connect splinted scan bodies), Group II (Reverse Scan Body technique), and Group III (conventional splinted open-tray impression with polyvinyl siloxane and Type IV stone casts). For each technique, a corresponding implant-supported framework will be fabricated and evaluated for passivity of fit using the Sheffield one-screw test and periapical radiographs taken with a paralleling device to assess microgaps at the implant-framework interface.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each patient will sequentially receive all three impression techniques (IO-Connect, Reverse Scan Body, and conventional splinted impression) for framework fabrication and passive fit evaluation.
| Arm | Type | Receives |
|---|---|---|
| Group I: IO-Connect | Active comparator | Procedure: IO-Connect Digital ImpressionPatients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with IO-Connect non-calibrated splinted scan bodies. |
| Group II: Reverse Scan Body | Active comparator | Procedure: Reverse Scan Body Digital ImpressionPatients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with the Reverse Scan Body (RSB) technique. |
| Group III: Conventional Impression | Active comparator | Procedure: Conventional Splinted ImpressionPatients received complete-arch implant-supported frameworks fabricated using a conventional splinted open-tray impression technique. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completely edentulous patients requiring full-arch implant-supported fixed prosthesis
- Age 35-70 years
- Adequate mandibular bone to place at least four implants without major grafting
- Ability to undergo digital scanning and radiographic evaluation
- Signed informed consent
Key exclusion criteria (5 listed)
- Systemic conditions affecting healing (uncontrolled diabetes, immunosuppression)
- History of head/neck radiotherapy or bisphosphonate therapy
- Active oral infection or severe bruxism
- Strong gag reflex preventing accurate scanning
- Poor compliance or unwillingness to attend follow-up visits
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 |
|---|---|---|
| IO-Connect Digital ImpressionDigital impression of the mandibular arch obtained using IO-Connect non-calibrated splinted scan bodies to fabricate the implant-supported framework for Group I. | Procedure or surgery | Group I: IO-Connect |
| Reverse Scan Body Digital ImpressionDigital impression obtained using the Reverse Scan Body (RSB) technique, involving extraoral scanning of scan bodies and superimposition with intraoral tissue scans, to fabricate the implant-supported framework for Group II. | Procedure or surgery | Group II: Reverse Scan Body |
| Conventional Splinted ImpressionConventional splinted open-tray impression using polyvinyl siloxane material and Type IV dental stone to fabricate the implant-supported framework for Group III. | Procedure or surgery | Group III: Conventional Impression |
Primary outcome
Passive Fit Assessed by Sheffield One-Screw Test
Time frame: The evaluation of passive fit by Sheffield one-screw test will be done 3 months after implant placement (3M-IP), at framework try-in for each of the three impression techniques.
The framework was seated on all implants and a single distal screw was fully tightened; remaining screw sites were examined visually and tactilely for lifting, rocking, or gaps as an indicator of passive fit.
Passive Fit Assessed by Periapical Radiographs
Time frame: The evaluation of passive fit by periapical radiographs will be done 3 months after implant placement, at framework try-in for each of the three impression techniques.
Intraoral periapical radiographs were obtained at each implant site using a paralleling device and evaluated for microgaps at the implant-framework interface.
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 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Fatma A El-Waseef, PhD study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IO-Connect Digital Impression, Reverse Scan Body Digital Impression and Conventional Splinted Impression in people with Dental Implants and Edentulous Jaw, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ahmed H Hazem Elsayed Helmi Atwa, BDS (+20 1092758696, ahmedhazem@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive Fit Assessed by Sheffield One-Screw Test (time frame: The evaluation of passive fit by Sheffield one-screw test will be done 3 months after implant placement (3M-IP), at framework try-in for each of the three impression techniques.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.