A Study of Surgical Guide Assisted Dental Implantation in Bangladesh
NCT ID: NCT05983718
Last Updated: 2023-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2023-08-23
2024-07-31
Brief Summary
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Detailed Description
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Free-hand implant surgeries are still in practice everywhere. The application of a guide pin has been observed in some places to enhance the situation. A guide pin helps an operator recognize the position and angle of an alveolar bone when forming an implantation hole in the alveolar bone to insert an implant into the alveolar bone. Doctors insert a guide pin to the implant site with minimal incision and then confirm the desired direction and location with a radiographic image. However, we need a proper clinical evaluation to compare fully-guided surgeries to guide-pin-assisted surgeries to understand the accuracy of both processes.
The accuracy of the pre-planned 3D-printed surgical guide is well established. Introducing dental software and guided surgery has already achieved higher acceptance in implant surgery. Several patients from several privileged parts of the world benefit from surgical guides. But the usual design convention includes intraoral scanner data with CBCT. However, intraoral scanners are still unavailable in many dental hospitals. The study is designed to address the precision of dental implant surgeries worldwide, especially where the intraoral scanner is not present. In our research, we will focus on partially edentulous patients. And our design procedure will not be dependent on intra-oral scanner data. As partially edentulous patients are higher in number and CBCT machines readily available in hospitals, this study can open up a way to address the scarcity of intra-oral scanner data to avail a large number of implant patients with an effective guide. The success rate of this study will encourage us not only to prioritize guided surgeries over free-hand practices or guide-pin-assisted surgeries but also to significantly impact the execution of implant surgeries in developing countries.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FREE HAND (GUIDE-PIN-assisted)
Guide-pin-assisted Freehand surgery
The regular protocol of the implant surgery will be followed. Before the surgery begins, the patient will be given anesthesia to ensure they are comfortable and pain-free during the procedure. Doctors will go through the digital planning to understand the desired angulation. Then the bony bed will be prepared raising flap from targeted area. Then a guide-pin will be inserted by drilling and through radiographic image the direction will be confirmed. Following the hole of the guide-pin, the implant will be inserted. At the end of the operation, the raised flap will be sewn and hemostasis will be provided. The operator records the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.
FULL GUIDED
Surgical Guide
For this case, after the patient is given anesthesia, the guide will be placed on the teeth. All the drillings will be performed through the guided path. There will be no need for raising flap according to flapless surgery. At the end of the operation, the operation site will be checked and hemostasis will be provided. The operator will record the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.
Interventions
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Surgical Guide
For this case, after the patient is given anesthesia, the guide will be placed on the teeth. All the drillings will be performed through the guided path. There will be no need for raising flap according to flapless surgery. At the end of the operation, the operation site will be checked and hemostasis will be provided. The operator will record the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.
Guide-pin-assisted Freehand surgery
The regular protocol of the implant surgery will be followed. Before the surgery begins, the patient will be given anesthesia to ensure they are comfortable and pain-free during the procedure. Doctors will go through the digital planning to understand the desired angulation. Then the bony bed will be prepared raising flap from targeted area. Then a guide-pin will be inserted by drilling and through radiographic image the direction will be confirmed. Following the hole of the guide-pin, the implant will be inserted. At the end of the operation, the raised flap will be sewn and hemostasis will be provided. The operator records the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.
Eligibility Criteria
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Inclusion Criteria
* Patient fit for implantation (satisfactory soft and hard tissue conditions and occlusion)
* Partially edentulous patient
Exclusion Criteria
* Patient with uncontrolled diabetes mellitus.
* Patient who needed dentoalveolar or associated soft tissue reconstruction procedure
* Patient taking bisphosphonate or have any history of systemic or local bone disease
* Recent extracted sites
* Patients with a history of smoking, alcoholism
* Patient with a history of head-neck radiation
* Patient with associated periapical pathology or history of parafunctional habit
* Patient needs bone grafting.
* Known HIV, Hepatitis B, or Hepatitis C infection.
* Limited mouth opening, which, in the examiner's opinion, would risk the success of the intervention
* Local infection
* Known allergy to any component of the implant or the implant guide
18 Years
75 Years
ALL
Yes
Sponsors
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Bangladesh University of Engineering and Technology
OTHER
Dhaka Dental College and Hospital
OTHER
Responsible Party
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Dr. Md. Al-Amin Sarkar
Junior Consultant
Principal Investigators
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Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)
Role: PRINCIPAL_INVESTIGATOR
Dhaka Dental College Hospital
Locations
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Dhaka Dental College and Hospital
Dhaka, , Bangladesh
Countries
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Central Contacts
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Facility Contacts
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References
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Albrektsson T, Dahl E, Enbom L, Engevall S, Engquist B, Eriksson AR, Feldmann G, Freiberg N, Glantz PO, Kjellman O, et al. Osseointegrated oral implants. A Swedish multicenter study of 8139 consecutively inserted Nobelpharma implants. J Periodontol. 1988 May;59(5):287-96. doi: 10.1902/jop.1988.59.5.287.
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Cassetta M, Stefanelli LV, Giansanti M, Di Mambro A, Calasso S. Depth deviation and occurrence of early surgical complications or unexpected events using a single stereolithographic surgi-guide. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1377-87. doi: 10.1016/j.ijom.2011.09.009. Epub 2011 Oct 15.
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Geng W, Liu C, Su Y, Li J, Zhou Y. Accuracy of different types of computer-aided design/computer-aided manufacturing surgical guides for dental implant placement. Int J Clin Exp Med. 2015 Jun 15;8(6):8442-9. eCollection 2015.
Israelson H, Plemons JM, Watkins P, Sory C. Barium-coated surgical stents and computer-assisted tomography in the preoperative assessment of dental implant patients. Int J Periodontics Restorative Dent. 1992;12(1):52-61.
Jacobs R, Adriansens A, Verstreken K, Suetens P, van Steenberghe D. Predictability of a three-dimensional planning system for oral implant surgery. Dentomaxillofac Radiol. 1999 Mar;28(2):105-11. doi: 10.1038/sj/dmfr/4600419.
Jacobs R, Adriansens A, Naert I, Quirynen M, Hermans R, Van Steenberghe D. Predictability of reformatted computed tomography for pre-operative planning of endosseous implants. Dentomaxillofac Radiol. 1999 Jan;28(1):37-41. doi: 10.1038/sj.dmfr.4600403.
Kernen F, Benic GI, Payer M, Schar A, Muller-Gerbl M, Filippi A, Kuhl S. Accuracy of Three-Dimensional Printed Templates for Guided Implant Placement Based on Matching a Surface Scan with CBCT. Clin Implant Dent Relat Res. 2016 Aug;18(4):762-8. doi: 10.1111/cid.12348. Epub 2015 Apr 28.
Kiatkroekkrai P, Takolpuckdee C, Subbalekha K, Mattheos N, Pimkhaokham A. Accuracy of implant position when placed using static computer-assisted implant surgical guides manufactured with two different optical scanning techniques: a randomized clinical trial. Int J Oral Maxillofac Surg. 2020 Mar;49(3):377-383. doi: 10.1016/j.ijom.2019.08.019. Epub 2019 Sep 20.
Lin CC, Ishikawa M, Maida T, Cheng HC, Ou KL, Nezu T, Endo K. Stereolithographic Surgical Guide with a Combination of Tooth and Bone Support: Accuracy of Guided Implant Surgery in Distal Extension Situation. J Clin Med. 2020 Mar 5;9(3):709. doi: 10.3390/jcm9030709.
Schneider D, Marquardt P, Zwahlen M, Jung RE. A systematic review on the accuracy and the clinical outcome of computer-guided template-based implant dentistry. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:73-86. doi: 10.1111/j.1600-0501.2009.01788.x.
Verstreken K, Van Cleynenbreugel J, Martens K, Marchal G, van Steenberghe D, Suetens P. An image-guided planning system for endosseous oral implants. IEEE Trans Med Imaging. 1998 Oct;17(5):842-52. doi: 10.1109/42.736056.
Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.
D'haese J, Van De Velde T, Komiyama A, Hultin M, De Bruyn H. Accuracy and complications using computer-designed stereolithographic surgical guides for oral rehabilitation by means of dental implants: a review of the literature. Clin Implant Dent Relat Res. 2012 Jun;14(3):321-35. doi: 10.1111/j.1708-8208.2010.00275.x. Epub 2010 May 11.
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Other Identifiers
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BME-BUET-DDCH-001
Identifier Type: -
Identifier Source: org_study_id
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