Atrophic MaxillaASG-EINCT06737289
SURGICAL GUIDES EFFECTIVENESS
A study testing Surgical Guide in people with Atrophic Maxilla, run by Universidad Complutense de Madrid at 2 sites in Spain.
Trial summary
The use of zygomatic implants is a technique that is becoming more and more widespread in daily clinical practice, however, few professionals feel safe and confident in performing this type of procedure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrophic Maxilla
- What is being tested?
- Surgical Guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 11 Dec 2024to 12 Oct 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age between 18-80 years of age, patients who sign the informed consent form and patients who consent to undergo preoperative and postoperative orthopantomography and CT scans.
Who cannot join
- Smoking (more than 10 cigarettes per day).
- Alcoholism (more than 25g/day in women and more than 40g/day in men according to WHO criteria),
- Oncological treatment (history of treatment in the last 6 months or current treatment with chemotherapy or radiotherapy).
- History of head and neck radiotherapy.
- Allergic to anesthetics or antibiotics.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Jesus
Madrid, 28040
Jesus Torres, PhD
- Recruiting
UCM
Madrid, 28040
About this study
Official title: PRECISION OF SURGICAL GUIDES FOR PLACEMENT OF EXTRA-LARGE DENTAL IMPLANTS. A PILOT STUDY
The use of zygomatic implants is a technique that is becoming more and more widespread in daily clinical practice, however, few professionals feel safe and confident in performing this type of procedure. We therefore believe that a line of research focused on simplifying this technique will have an extraordinary impact on the safety of both patients and surgeons. Currently, new surgical guides have emerged that guarantee greater precision in the placement of zygomatic implants. However, no comparative clinical studies have yet been performed to evaluate the degree of accuracy of guided implant placement compared to the conventional freehand technique.
Read the detailed description
The primary objective of the study is to study the accuracy of the use of guided surgical splints compared to traditional freehand zygomatic implant placement.
The secondary objectives are:
- To compare the magnitude of variations depending on implant length by superimposing postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
- To compare the magnitude of the variations depending on the location of the implant by superimposing postoperative and postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
- To assess the clinical relevance of cogomatic implant placement using guided surgical splinting on pain parameters and surgical time.
- Conditions
- Atrophic Maxilla
- Being tested
- Surgical Guide
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical GuideProcedure or surgery
Placing extralarge implats for rahabilitation atrophic maxilla
| Study group | Role | What they receive |
|---|---|---|
| Guide Surgery Arm | Experimental | Use of Surgical Guide Receives: Procedure: Surgical Guide |
| Control | Placebo comparator | Hand Free Implant Placement Receives: Procedure: Surgical Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Surgical Guides in implant placement
Accuracy of Surgical Guides in terms of Radiological differences in implant placement. The primary outcome is to measure the differences existing between implant planificación and final implant placement. First, a computed tomography (CT) scan will be performed to plan the placement of the zygomatic implants. Once the implants have been placed in both groups, another CT scan will be performed to evaluate the following parameters using 3DSlicer® software (http://www.slicer.org). Three-dimensional lateral apical implant deviation and three-dimensional lateral neck implant deviation respect to the original digital planning will be evaluated by superimposing images.
3D lateral deviations will be measured in mm in relation with original planning.
Also deviations in degrees between the original planning and the final placements will be evaluated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start11 Dec 2024
- Primary completion12 Jun 2025 (estimated)
- Study completion12 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic MaxillaStudies 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
- Model description
- Split Mouth Design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Torres García Denche, Universidad Complutense de Madrid
- Investigators
- JEsus Torres, PhD, Principal investigator, UCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737289
- Sponsor's protocol ID
- C.I. 24/728-E
- Acronym
- ASG-EI
- Status last verified
- Nov 2024
- First submitted
- 30 Nov 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECISION OF SURGICAL GUIDES FOR PLACEMENT OF EXTRA-LARGE DENTAL IMPLANTS. A PILOT STUDY
- ClinicalTrials.gov ID
- NCT06737289
- Acronym / sponsor ID
- ASG-EI / C.I. 24/728-E
- Conditions
- Atrophic Maxilla
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 12 Jun 2025 (estimated)
- Study completion
- 12 Oct 2025 (estimated)
- First posted
- 17 Dec 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.
The use of zygomatic implants is a technique that is becoming more and more widespread in daily clinical practice, however, few professionals feel safe and confident in performing this type of procedure. We therefore believe that a line of research focused on simplifying this technique will have an extraordinary impact on the safety of both patients and surgeons. Currently, new surgical guides have emerged that guarantee greater precision in the placement of zygomatic implants. However, no comparative clinical studies have yet been performed to evaluate the degree of accuracy of guided implant placement compared to the conventional freehand technique.
Detailed description
The primary objective of the study is to study the accuracy of the use of guided surgical splints compared to traditional freehand zygomatic implant placement.
The secondary objectives are:
- To compare the magnitude of variations depending on implant length by superimposing postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
- To compare the magnitude of the variations depending on the location of the implant by superimposing postoperative and postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
- To assess the clinical relevance of cogomatic implant placement using guided surgical splinting on pain parameters and surgical time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split Mouth Design
| Arm | Type | Receives |
|---|---|---|
| Guide Surgery Arm | Experimental | Procedure: Surgical GuideUse of Surgical Guide |
| Control | Placebo comparator | Procedure: Surgical GuideHand Free Implant Placement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18-80 years of age, patients who sign the informed consent form and patients who consent to undergo preoperative and postoperative orthopantomography and CT scans.
Key exclusion criteria (5 listed)
- Smoking (more than 10 cigarettes per day).
- Alcoholism (more than 25g/day in women and more than 40g/day in men according to WHO criteria),
- Oncological treatment (history of treatment in the last 6 months or current treatment with chemotherapy or radiotherapy).
- History of head and neck radiotherapy.
- Allergic to anesthetics or antibiotics.
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 |
|---|---|---|
| Surgical GuidePlacing extralarge implats for rahabilitation atrophic maxilla | Procedure or surgery | Control, Guide Surgery Arm |
Primary outcome
Accuracy of Surgical Guides in implant placement
Time frame: 12 months
Accuracy of Surgical Guides in terms of Radiological differences in implant placement. The primary outcome is to measure the differences existing between implant planificación and final implant placement. First, a computed tomography (CT) scan will be performed to plan the placement of the zygomatic implants. Once the implants have been placed in both groups, another CT scan will be performed to evaluate the following parameters using 3DSlicer® software (http://www.slicer.org). Three-dimensional lateral apical implant deviation and three-dimensional lateral neck implant deviation respect to the original digital planning will be evaluated by superimposing images. 3D lateral deviations will be measured in mm in relation with original planning. Also deviations in degrees between the original planning and the final placements will be evaluated.
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 20 Dec 2024.
Related trials for Atrophic Maxilla
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Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
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Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Alveolar Bone Loss
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Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
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Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant
Severe Maxillary Atrophy
Recruiting
Graftless TSFE Via Self-tapping Implants
Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization
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.
JEsus Torres, PhD principal investigator
UCM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Guide in people with Atrophic Maxilla, run by Universidad Complutense de Madrid at 2 sites in Spain.
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 1 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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. Some participants in this study may receive a placebo. 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 Jesus Torres, PhD (653050071, jesus.torres@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Surgical Guides in implant placement (time frame: 12 months). 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 20 Dec 2024.