3D-Printed PLA Guide Versus Resin Guide in Mandibular Molar Implant Placement (CGIIPMM-PLA-MR)
12. september 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New Cairo
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Cairo, New Cairo, Egypten, 11511
- Future University in Egypt (FUE)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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accuracy of implant position
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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primary implant stability by osstell
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. november 2025
Primær færdiggørelse (Faktiske)
10. august 2026
Studieafslutning (Faktiske)
10. september 2026
Datoer for studieregistrering
Først indsendt
12. september 2026
Først indsendt, der opfyldte QC-kriterier
12. september 2026
Først opslået (Faktiske)
17. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- FUE.REC(78)/10-2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data will not be shared because of participant privacy and confidentiality considerations.
Only aggregate study results will be reported.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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