Clinical trial NCT06417788: Dynamic Guided Implant Surgery VS Static Guided Surgery.
Official title: Dynamic Guided Implant Surgery VS Static Guided Surgery. A Pilot Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Partially Edentulous Patients
Bone Crest of at Least 10 mm Length and 6 mm Width
Patients of at Least 18 Years Old
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who need dental implants and fulfill the inclusion criteria will be randomly allocated to test group (dynamic guided system) or control group (static stereolithographic pilot drill guided system)
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study aims to evaluate if dynamic-guided surgery is an accurate system for placing dental implants.

Researchers will assess the dental implant accuracy of the dynamic guided system compared to the static pilot guide.

Participants will:

* Receive implant treatment that will be placed by a dynamic or static pilot drill guided system.
* Receive post-operative radiological exam for comparative (on the same appointment).


Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* ASA type 1 or 2,
* Full mouth plaque scores up to 25% (O'LEARY TJ. The plaque control record 1972;43:38), -Partially edentulous with at least one missing tooth
* Having a bone crest of at least 10mm in length and 6mm in width.

Exclusion Criteria:

* medical conditions contraindicating surgery,
* untreated periodontal disease or caries
* the need for bone augmentation
* acute local infections
* history of head/neck radiation.

Primary outcomes:
measure: Implant placement accuracy at the implant platform level
timeFrame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
measure: Implant placement accuracy at the implant apex level
timeFrame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
measure: Implant placement accuracy at an angular evel
timeFrame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
measure: Implant placement accuracy at the vertical plane.
timeFrame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
citation: Somogyi-Ganss E, Holmes HI, Jokstad A. Accuracy of a novel prototype dynamic computer-assisted surgery system. Clin Oral Implants Res. 2015 Aug;26(8):882-890. doi: 10.1111/clr.12414. Epub 2014 May 19.
citation: Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x.
citation: Hultin M, Svensson KG, Trulsson M. Clinical advantages of computer-guided implant placement: a systematic review. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:124-35. doi: 10.1111/j.1600-0501.2012.02545.x.
citation: Block MS, Emery RW, Lank K, Ryan J. Implant Placement Accuracy Using Dynamic Navigation. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):92-99. doi: 10.11607/jomi.5004. Epub 2016 Sep 19.
citation: D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175.
citation: Sun TM, Lan TH, Pan CY, Lee HE. Dental implant navigation system guide the surgery future. Kaohsiung J Med Sci. 2018 Jan;34(1):56-64. doi: 10.1016/j.kjms.2017.08.011. Epub 2017 Dec 8.
citation: Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.
citation: O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
citation: Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/