Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Graft Versus Conventional Immediate Implant Placement With Xenograft (RCT)
This randomized controlled clinical trial will evaluate a computer-guided immediate implant placement technique in non-restorable mandibular molars using a patient-specific 3D-printed polylactic acid (PLA) graft and implant position guide, compared with conventional immediate implant placement using xenograft for grafting of the jumping gap.
Eligible patients requiring extraction and immediate implant placement in mandibular molars will be randomly allocated to either the PLA-guided intervention group or the conventional treatment group. In the intervention group, a patient-specific 3D-printed PLA graft and guide will be designed from preoperative CBCT data and used to guide implant placement in the digitally planned position. In the control group, immediate implant placement will be performed using the conventional protocol with xenograft grafting.
The study will assess the primary stability of the dental implant and the accuracy of implant placement compared with the digitally planned position. Implant stability will be measured using the Osstell device, while implant position will be evaluated by superimposing the immediate postoperative CBCT scan on the preoperative CBCT using Blue-Sky Plan software.
Patients will be followed clinically after surgery, with follow-up visits during the healing period and a six-month postoperative CBCT evaluation before implant loading.
Study Overview
Status
Detailed Description
This is a prospective randomized controlled clinical trial designed to evaluate computer-guided immediate implant placement in mandibular molar extraction sockets using a patient-specific 3D-printed polylactic acid (PLA) socket guide and customized root-form PLA graft, compared with conventional freehand immediate implant placement using xenograft.
Immediate implant placement in mandibular molar extraction sockets can be challenging because of the wide socket morphology and the limited amount of bone available for achieving primary implant stability. The interradicular septum and apical bone are important for implant anchorage, while the irregular shape of the extraction socket may make conventional freehand osteotomy preparation and implant positioning difficult.
In the experimental group, preoperative cone-beam computed tomography (CBCT) data will be used for three-dimensional digital planning of the implant position. The implant position, angulation, diameter, and length will be planned using Blue Sky Plan 4 software. A patient-specific socket-supported PLA surgical guide will then be designed according to the planned implant position. A customized root-form PLA graft will also be designed to fit the peri-implant gap within the extraction socket.
The PLA socket guide and customized PLA graft will be fabricated using additive manufacturing. The patient-specific guide will be used during osteotomy preparation to control the drilling trajectory and facilitate placement of the implant according to the digitally planned position. The customized PLA graft will be positioned within the residual gap between the implant and extraction socket walls.
Participants allocated to the control group will undergo conventional immediate implant placement using a freehand surgical technique. Xenograft will be used for grafting of the peri-implant gap according to the conventional treatment protocol.
All participants will undergo preoperative clinical and radiographic assessment. Clinical assessment includes medical and dental history, periodontal assessment, occlusal assessment, and plaque-control assessment. CBCT will be used to evaluate the extraction socket, root morphology, interradicular bone, and available bone dimensions before implant placement.
The primary outcomes of the study are implant primary stability and implant positional accuracy. Implant stability will be assessed using resonance frequency analysis/implant stability measurement at the time of implant placement and during follow-up. Implant positional accuracy will be assessed by comparing the virtually planned implant position with the actual postoperative implant position using CBCT-based evaluation. Positional accuracy will be assessed as a single positional accuracy outcome incorporating the measured deviations between the planned and actual implant position.
Participants will be followed clinically during the healing period, with assessment of implant stability at the planned follow-up period. A postoperative CBCT examination will be used to evaluate the actual implant position and compare it with the preoperative virtual plan.
The study is intended to determine whether the patient-specific 3D-printed PLA socket guide and customized PLA graft can improve primary implant stability and the accuracy of immediate implant placement compared with the conventional freehand technique using xenograft.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Cairo, Egypt
- Department of Oral & Maxillofacial Surgery , Faculty of Oral & Dental Medicine , Future University in Egypt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients requiring immediate implant placement in mandibular molar extraction sockets.
- Patients with adequate bone volume to accommodate the planned implant.
- Patients willing to undergo immediate implant placement and follow-up for 6 months.
- Patients who provided informed consent.
Exclusion Criteria:
- Uncontrolled systemic diseases or medical conditions contraindicating implant surgery.
- Patients receiving medications or treatments that may adversely affect bone healing.
- smokers.
- Poor oral hygiene or uncontrolled periodontal disease.
- Acute uncontrolled infection at the surgical site.
- Conditions requiring additional bone augmentation beyond the study protocol.
- Patients unable or unwilling to attend the required follow-up visits.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: PLA-Guided immediate implant placement
Immediate implant placement using a patient-specific 3D-printed PLA socket guide and customized root-form PLA scaffold
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A patient-specific 3D-printed polylactic acid (PLA) socket-supported surgical guide was used to guide implant osteotomy preparation, combined with a customized root-form PLA scaffold designed to occupy the residual peri-implant socket gap and provide structural support during immediate implant placement in mandibular molars.
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Active Comparator: Conventional Immediate Implant Placement
Freehand immediate implant placement with particulate xenograft to fill the residual peri-implant socket gap
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Freehand immediate implant placement with particulate xenograft to fill the residual peri-implant socket gap.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Implant primary stability (IST)
Time Frame: Immediately after implant placement
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Primary implant stability was measured using resonance frequency analysis and expressed as an Implant Stability Quotient (IST) value.
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Immediately after implant placement
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Implant stability at 6 months (IST)
Time Frame: 6 months after implant placement
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Implant stability was assessed using resonance frequency analysis and expressed as an Implant Stability Quotient (IST) value.
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6 months after implant placement
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Implant positional accuracy
Time Frame: Immediately after implant placement
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Implant positional accuracy was assessed by comparing the planned and actual implant positions using postoperative CBCT, including coronal, apical, and angular deviations.
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Immediately after implant placement
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Sanz M, Lindhe J, Alcaraz J, Sanz-Sanchez I, Cecchinato D. The effect of placing a bone replacement graft in the gap at immediately placed implants: a randomized clinical trial. Clin Oral Implants Res. 2017 Aug;28(8):902-910. doi: 10.1111/clr.12896. Epub 2016 Jun 7.
- Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
- Hallman M, Thor A. Bone substitutes and growth factors as an alternative/complement to autogenous bone for grafting in implant dentistry. Periodontol 2000. 2008;47:172-92. doi: 10.1111/j.1600-0757.2008.00251.x. No abstract available.
- Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.
- Tümer EH, Erbil HY. Extrusion-based 3D printing applications of PLA composites: a review.
- Rabel A, Kohler SG, Schmidt-Westhausen AM. Clinical study on the primary stability of two dental implant systems with resonance frequency analysis. Clin Oral Investig. 2007 Sep;11(3):257-65. doi: 10.1007/s00784-007-0115-2. Epub 2007 Mar 31.
- Gopalakrishnan K, Chandrasekaran B, John RR. Comparison of accuracy of immediate implant placement between planned and actual position in pre-extractive versus conventional method - A prospective study. J Craniomaxillofac Surg. 2024 May;52(5):598-605. doi: 10.1016/j.jcms.2024.02.020. Epub 2024 Feb 12.
- DeStefano V, Khan S, Tabada A. Applications of PLA in modern medicine. Eng Regen. 2020;1:76-87. doi: 10.1016/j.engreg.2020.08.002. Epub 2020 Sep 6.
- Singhvi MS, Zinjarde SS, Gokhale DV. Polylactic acid: synthesis and biomedical applications. J Appl Microbiol. 2019 Dec;127(6):1612-1626. doi: 10.1111/jam.14290. Epub 2019 Jun 17.
- Ortega-Martinez J, Perez-Pascual T, Mareque-Bueno S, Hernandez-Alfaro F, Ferres-Padro E. Immediate implants following tooth extraction. A systematic review. Med Oral Patol Oral Cir Bucal. 2012 Mar 1;17(2):e251-61. doi: 10.4317/medoral.17469.
- Verket A, Lyngstadaas SP, Tiainen H, Ronold HJ, Wohlfahrt JC. Impact of particulate deproteinized bovine bone mineral and porous titanium granules on early stability and osseointegration of dental implants in narrow marginal circumferential bone defects. Int J Oral Maxillofac Surg. 2018 Aug;47(8):1086-1094. doi: 10.1016/j.ijom.2018.02.007. Epub 2018 Mar 20.
- Meijer HJA, Raghoebar GM. Immediate implant placement in molar extraction sites: a 1-year prospective case series pilot study. Int J Implant Dent. 2020 Feb 12;6(1):3. doi: 10.1186/s40729-019-0201-7.
- Valente F, Schiroli G, Sbrenna A. Accuracy of computer-aided oral implant surgery: a clinical and radiographic study. Int J Oral Maxillofac Implants. 2009 Mar-Apr;24(2):234-42.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FUE.REC (53)/11-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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