Complete EdentulismNCT06542562
Accuracy of Fully Guided Versus Half Guided Implant
A study testing guided implant placement in people with Complete Edentulism, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
six implants will be placed in edentulous maxilla to rehabilitate patients with implant prosthesis.The primary outcome measure will be the accuracy of implant placement, which will be evaluated using cone-beam computed tomography (CBCT) scans Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- guided implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Complete edentulism
- Adequate bone volume to accommodate six standard implant fixtures (3.7 mm diameter and 10 mm length)
- All patients underwent a panoramic X-ray and an oral examination
- Written consent provided prior to participation
Who cannot join
- Patients with partial edentulism
- Insufficient bone volume for a 3.7 mm diameter and 10 mm length implant fixture
- Local or systemic conditions that could impede dental implant surgery
- Patients who smoke more than five cigarettes per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Fully Guided Versus Half Guided Implant Placement in Patients With Edentulous Maxilla: A Split-mouth Randomized Clinical Trial
six implants will be placed in edentulous maxilla to rehabilitate patients with implant prosthesis.The primary outcome measure will be the accuracy of implant placement, which will be evaluated using cone-beam computed tomography (CBCT) scans
Read the detailed description
Study Design:
This will be a Split mouth randomized controlled trial (RCT) study. 16 patients missing teeth in the maxillary (upper) jaw and eligible for dental implant treatment will be recruited.
Interventions will be randomly assigned to the right or the left side of the arch :
Group 1 will undergo fully guided dental implant surgery. Group 2 will undergo partially guided dental implant surgery.
Study Duration:
The total duration of the study is estimated to be 5 months. Recruitment and enrollment of patients: 1 months Dental implant surgery : 3 months Data analysis and manuscript preparation: 1 months
The key steps are:
Recruit 16 eligible patients missing teeth in the maxillary jaw. Randomly assign right or left side of the maxillary arch of patients to either the fully guided or partially guided implant surgery group.
Perform CBCT (cone-beam computed tomography) scans before and after the implant surgery for both groups.
Assess the accuracy of implant placement in both groups using the CBCT data. Conduct statistical analysis to determine if there are any statistically significant differences in implant placement accuracy between the two groups.
Interpret the results and develop recommendations on the optimal guided surgery technique for rehabilitating the edentulous maxilla using dental implants.
The study aims to provide scientific evidence to guide clinicians in selecting the most appropriate guided surgery approach for maxillary implant rehabilitation
- Conditions
- Complete Edentulism
- Being tested
- guided implant placement
- Keywords
- implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided implant placementProcedure or surgery
The key difference is that in Group 1, the guide is only used for the drilling sequence, while in Group 2 the guide is used for both the drilling and the actual implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 will undergo fully guided dental implant surgery | Experimental | Group 1 will undergo fully guided dental implant surgery Receives: Procedure: guided implant placement |
| Group 2 will undergo half guided dental implant surgery | Experimental | Group 2 will undergo half guided dental implant surgery. Where the implant will be placed after removal of the guide Receives: Procedure: guided implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Angle Deviation in Implant Placement: Fully Guided vs. Half-Guided Approaches
Post-surgery, 16 patients will be scanned using the same CBCT machine and exposure settings. Preoperative and postoperative CBCT scans will be imported into the In2Guide™ software, where an overlay of the preoperative plane onto the postoperative scan allowed for precise evaluation of implant positioning. Implant deviations will be measured in three directions: angular deviation, deviation at the coronal platform (entry deviation), and deviation at the apical portion (Figure 2). The software generated coordinates for the necessary calculations, with coronal and apical deviations reported in millimeters and angular deviation in degrees.
Measured: at the day of implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Aug 2024
- Primary completion24 Mar 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complete EdentulismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542562
- Sponsor's protocol ID
- UMSA
- Status last verified
- Jul 2024
- First submitted
- 5 Aug 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alqutaibi AY, Al-Gabri RS, Ibrahim WI, Elawady D. Trueness of fully guided versus partially guided implant placement in edentulous maxillary rehabilitation: a split-mouth randomized clinical trial. BMC Oral Health. 2025 Oct 27;25(1):1680. doi: 10.1186/s12903-025-07073-0.
PubMed 41146170
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Fully Guided Versus Half Guided Implant Placement in Patients With Edentulous Maxilla: A Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06542562
- Acronym / sponsor ID
- UMSA
- Conditions
- Complete Edentulism
- Keywords
- implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 7 Aug 2024 (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.
six implants will be placed in edentulous maxilla to rehabilitate patients with implant prosthesis.The primary outcome measure will be the accuracy of implant placement, which will be evaluated using cone-beam computed tomography (CBCT) scans
Detailed description
Study Design:
This will be a Split mouth randomized controlled trial (RCT) study. 16 patients missing teeth in the maxillary (upper) jaw and eligible for dental implant treatment will be recruited.
Interventions will be randomly assigned to the right or the left side of the arch :
Group 1 will undergo fully guided dental implant surgery. Group 2 will undergo partially guided dental implant surgery.
Study Duration:
The total duration of the study is estimated to be 5 months. Recruitment and enrollment of patients: 1 months Dental implant surgery : 3 months Data analysis and manuscript preparation: 1 months
The key steps are:
Recruit 16 eligible patients missing teeth in the maxillary jaw. Randomly assign right or left side of the maxillary arch of patients to either the fully guided or partially guided implant surgery group.
Perform CBCT (cone-beam computed tomography) scans before and after the implant surgery for both groups.
Assess the accuracy of implant placement in both groups using the CBCT data. Conduct statistical analysis to determine if there are any statistically significant differences in implant placement accuracy between the two groups.
Interpret the results and develop recommendations on the optimal guided surgery technique for rehabilitating the edentulous maxilla using dental implants.
The study aims to provide scientific evidence to guide clinicians in selecting the most appropriate guided surgery approach for maxillary implant rehabilitation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 will undergo fully guided dental implant surgery | Experimental | Procedure: guided implant placementGroup 1 will undergo fully guided dental implant surgery |
| Group 2 will undergo half guided dental implant surgery | Experimental | Procedure: guided implant placementGroup 2 will undergo half guided dental implant surgery. Where the implant will be placed after removal of the guide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older
- Complete edentulism
- Adequate bone volume to accommodate six standard implant fixtures (3.7 mm diameter and 10 mm length)
- All patients underwent a panoramic X-ray and an oral examination
- Written consent provided prior to participation
Key exclusion criteria (4 listed)
- Patients with partial edentulism
- Insufficient bone volume for a 3.7 mm diameter and 10 mm length implant fixture
- Local or systemic conditions that could impede dental implant surgery
- Patients who smoke more than five cigarettes per day
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 |
|---|---|---|
| guided implant placementThe key difference is that in Group 1, the guide is only used for the drilling sequence, while in Group 2 the guide is used for both the drilling and the actual implant placement. | Procedure or surgery | Group 1 will undergo fully guided dental implant surgery, Group 2 will undergo half guided dental implant surgery |
Primary outcome
Rate of Angle Deviation in Implant Placement: Fully Guided vs. Half-Guided Approaches
Time frame: at the day of implant placement
Post-surgery, 16 patients will be scanned using the same CBCT machine and exposure settings. Preoperative and postoperative CBCT scans will be imported into the In2Guide™ software, where an overlay of the preoperative plane onto the postoperative scan allowed for precise evaluation of implant positioning. Implant deviations will be measured in three directions: angular deviation, deviation at the coronal platform (entry deviation), and deviation at the apical portion (Figure 2). The software generated coordinates for the necessary calculations, with coronal and apical deviations reported in millimeters and angular deviation in degrees.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Derived from this study: PubMed 41146170Alqutaibi AY, Al-Gabri RS, Ibrahim WI, Elawady D. Trueness of fully guided versus partially guided implant placement in edentulous maxillary rehabilitation: a split-mouth randomized clinical trial. BMC Oral Health. 2025 Oct 27;25(1):1680. doi: 10.1186/s12903-025-07073-0.
- Individual participant dataSharing planned: No
Related trials for Complete Edentulism
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Recruiting
Accuracy of Complete-Arch Implant Scans Using Non Calibrated Splinting Scanbodies
Edentulism Complete
Active, not recruiting
Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis.
Complete Edentulism
Not yet recruiting
Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
Edentulism
Recruiting
Nutritional Intervention for Older Adults With Complete Dentures
Edentulism Complete, Denture, Complete
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided implant placement in people with Complete Edentulism, run by October University for Modern Sciences and Arts 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 4 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: finished, as of the sponsor's last update on 1 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Angle Deviation in Implant Placement: Fully Guided vs. Half-Guided Approaches (time frame: at the day of implant placement). 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 NCT06542562, which also lists 1 linked publication.
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 1 Aug 2025.