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- Klinische proef NCT07627841
Accuracy of Computer Guided Implant Placement in Edentulous or Partially Edentulous Patients Using Artificial Intelligence Technology vs Conventional Method A Randomized Clinical Trial
Studie Overzicht
Toestand
Gedetailleerde beschrijving
This clinical study is being conducted at Future University in Egypt as part of a doctoral research project in Oral and Maxillofacial Surgery. The purpose of the study is to evaluate and compare the accuracy of dental implant placement using two different computer-guided techniques: an Artificial Intelligence (AI)-assisted digital planning method and a conventional computer-guided planning method.
Dental implants are commonly used to replace missing teeth and restore oral function and appearance. Accurate implant placement is very important to avoid complications and to ensure long-term success. Modern implant dentistry increasingly depends on digital planning and 3D surgical guides to improve safety and precision during surgery.
In this study, patients who are partially or completely missing teeth will undergo clinical examination and CBCT (Cone Beam Computed Tomography) imaging before treatment. Participants will then be randomly assigned into one of two groups. The first group will use AI-assisted planning software that automatically helps identify important anatomical structures, detects missing teeth, and assists in planning the ideal implant position. The second group will use a conventional digital planning method performed manually by the clinician using standard software.
For both groups, a customized surgical guide will be designed and fabricated using 3D-printing technology. During surgery, the guide will help the surgeon place the dental implants in the planned position with high precision. After implant placement, patients will receive routine postoperative care and follow-up. A healing period of approximately three months will be allowed before placement of the final crown or bridge restoration.
To evaluate the accuracy of the procedure, postoperative CBCT scans will be compared with the original virtual treatment plan. The study will measure any differences between the planned and actual implant positions, including implant depth, angle, and overall positioning.
The study aims to determine whether AI-assisted implant planning can improve the precision, efficiency, and predictability of guided implant surgery compared with conventional digital planning methods. The results may contribute to improving future dental implant treatment and digital surgical workflows.
Participation in this study is voluntary, and all patient information will remain confidential. Possible risks are similar to those associated with standard dental implant surgery and may include pain, swelling, bleeding, infection, temporary numbness, or implant failure. Patients will be closely monitored throughout treatment, and any complications will be managed by the research team.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New Cairo
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Cairo, New Cairo, Egypte, 11835
- Future University in Egypt
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Patients who are partially or completely edentulous.
- Patient aged 21 to 60 years old
- A willingness to cooperate with study protocol and follow-up program
Exclusion Criteria:
- Medical contraindications to dental treatment.
- Uncontrolled periodontal disease that interfere with healing.
- Cancer Patient (under radiation / chemotherapy).
- Present of any acute local infection.
- Uncontrolled diabetic patient.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Group A: AI-assisted computer-guided implant planning
The surgical guide will be utilized using Bluesky bio software and Perfactory Micro 3D printing machine.
The BlueSky software using AI automatically detects the nerves, detects the missing teeth, and places the dental implant and fabricate the surgical stent.
The stent is then exported to STL file and printed.
It will be positioned on the mandible or the maxilla.
The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide.
|
The surgical guide will be utilized using Bluesky bio software and Perfactory Micro 3D printing machine.
The BlueSky software using AI automatically detects the nerves, detects the missing teeth, and places the dental implant and fabricate the surgical stent.
The stent is then exported to STL file and printed.
It will be positioned on the mandible or the maxilla.
The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide CBCT will be taken post-operatively for the patient with the implants in place.
The pre-operative and postoperative CBCT plan will be superimposed virtually and any deviations in implant depth or angulations in different planes different from the plan will be recorded.
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Actieve vergelijker: Group B: Conventional computer-guided implant planning
The surgical guide will be created utilizing PlastyCAD Software and Perfactory Micro 3D printing machine.
It will be positioned on the mandible or the maxilla.
The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide.
This procedure will be performed on both completely edentulous and partially edentulous patients.
|
The surgical guide will be created utilizing PlastyCAD Software and Perfactory Micro 3D printing machine. It will be positioned on the mandible or the maxilla. The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide. This procedure will be performed on both completely edentulous and partially edentulous patients. CBCT will be taken post-operatively for the patient with the implants in place. The pre-operative and postoperative CBCT plan will be superimposed virtually and any deviations in implant depth or angulations in different planes different from the plan will be recorded. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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implant angular deviation and implant depth
Tijdsspanne: From enrollment to the end of treatment at 12 weeks
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CBCT will be taken post-operatively for the patient with the implants in place.
The pre-operative and postoperative CBCT plan will be superimposed virtually and any deviations in implant depth or angulations in different planes different from the plan will be recorded.
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From enrollment to the end of treatment at 12 weeks
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- FUE.REC(42)/12-2023
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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