3D-Printed PLA Guide Versus Resin Guide in Mandibular Molar Implant Placement (CGIIPMM-PLA-MR)
12 september 2026 bijgewerkt door: Mohamed Esmail Ahmed Hassan
Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Guide Versus Modified Resin Guide
This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed PLA guide system and a modified resin guide system.
The study evaluates implant positioning accuracy, primary implant stability, and surgical time.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed polylactic acid (PLA) guide system and a modified resin guide system. Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and fabrication of the surgical guides.
Implant positioning accuracy was assessed by comparing the planned and actual implant positions using preoperative and postoperative CBCT datasets. Angular deviation, coronal deviation at the implant platform, and apical deviation were recorded.
Primary implant stability was assessed immediately after implant placement using Implant Stability Quotient (ISQ) measurements obtained with an Osstell device. Surgical time was recorded from seating of the surgical guide and initiation of osteotomy until completion of implant insertion.
The study was designed to compare the performance of the two guide systems in immediate mandibular molar implant placement.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
20
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New Cairo
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Cairo, New Cairo, Egypte, 11511
- Future University in Egypt (FUE)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Age 20-50 years.
- Non-restorable mandibular first molar indicated for extraction.
- Sufficient bony support for implant placement without the need for significant bone augmentation.
- Good oral hygiene and motivation.
- Adequate prosthetic space.
- Ability and willingness to undergo the surgical procedure and follow-up.
- Suitable for computer-guided, tooth-supported implant placement.
Exclusion Criteria:
- Uncontrolled systemic diseases that may impair healing (e.g., uncontrolled diabetes or hypertension).
- Severe periodontal disease.
- Patients undergoing chemotherapy or radiotherapy.
- Insufficient prosthetic space.
- Heavy smokers.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: patient specific 3d printed PLA guide
Immediate implant placement in mandibular molar extraction sockets using a patient-specific tooth-supported 3D-printed PLA surgical guide system.
Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication.
The guide was fabricated from PLA according to the planned implant position.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
Preoperative virtual planning was performed using CBCT data and digital intraoral scans.
The datasets were used for prosthetically driven implant planning and fabrication of a patient-specific 3D-printed PLA surgical guide.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory.
The implant was then immediately inserted.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
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Actieve vergelijker: Modified Resin guide
Immediate implant placement in mandibular molar extraction sockets using a tooth-supported modified resin surgical guide system.
Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication.
The guide was fabricated from light-cured surgical-guide resin according to the planned implant position.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
Preoperative virtual planning was performed using CBCT data and digital intraoral scans.
The datasets were used for prosthetically driven implant planning and fabrication of a tooth-supported modified resin surgical guide.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory.
The implant was then immediately inserted.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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accuracy of implant position
Tijdsspanne: Assessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.
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Accuracy of implant placement will be evaluated by comparing the planned implant position from the preoperative digital plan with the actual implant position obtained from the postoperative CBCT scan.
Deviations will be assessed in three dimensions, including angular deviation (degrees), coronal deviation (platform) (mm), and apical deviation (mm).
Measurements will be performed using specialized implant-planning software by superimposing the preoperative and postoperative datasets.
Lower deviation values indicate greater agreement between the planned and actual implant positions.
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Assessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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primary implant stability by osstell
Tijdsspanne: Measured immediately at the time of implant placement during the surgical procedure.
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Primary implant stability will be assessed using an Osstell device, which measures Implant Stability Quotient (ISQ) values through resonance frequency analysis.
A SmartPeg will be attached to the implant, and ISQ readings will be taken in two perpendicular directions (buccolingual and mesiodistal).
Higher ISQ values indicate greater mechanical stability.
The mean ISQ value for each implant will be recorded and used for analysis
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Measured immediately at the time of implant placement during the surgical procedure.
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surgical time
Tijdsspanne: Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery
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Surgical time will be recorded to evaluate the procedural efficiency of guided immediate implant placement.
Time will be measured from seating of the surgical guide and initiation of osteotomy until completion of implant insertion.
The total duration will be recorded in minutes.
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Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Shi Y, Wang J, Ma C, Shen J, Dong X, Lin D. A systematic review of the accuracy of digital surgical guides for dental implantation. Int J Implant Dent. 2023 Oct 25;9(1):38. doi: 10.1186/s40729-023-00507-w.
- Ragucci GM, Elnayef B, Criado-Camara E, Del Amo FS, Hernandez-Alfaro F. Immediate implant placement in molar extraction sockets: a systematic review and meta-analysis. Int J Implant Dent. 2020 Oct 13;6(1):40. doi: 10.1186/s40729-020-00235-5.
- Ku JK, Lee J, Lee HJ, Yun PY, Kim YK. Accuracy of dental implant placement with computer-guided surgery: a retrospective cohort study. BMC Oral Health. 2022 Jan 16;22(1):8. doi: 10.1186/s12903-022-02046-z.
- Pieralli S, Spies BC, Hromadnik V, Nicic R, Beuer F, Wesemann C. How Accurate Is Oral Implant Installation Using Surgical Guides Printed from a Degradable and Steam-Sterilized Biopolymer? J Clin Med. 2020 Jul 22;9(8):2322. doi: 10.3390/jcm9082322.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
2 november 2025
Primaire voltooiing (Werkelijk)
10 augustus 2026
Studie voltooiing (Werkelijk)
10 september 2026
Studieregistratiedata
Eerst ingediend
12 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
12 september 2026
Eerst geplaatst (Werkelijk)
17 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 september 2026
Laatste update ingediend die voldeed aan QC-criteria
12 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- FUE.REC(78)/10-2025
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data will not be shared because of participant privacy and confidentiality considerations.
Only aggregate study results will be reported.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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