Dynamic Guided Implant Surgery VS Static Guided Surgery.

Partially Edentulous Patients Clinical Trial

Official title:

Dynamic Guided Implant Surgery VS Static Guided Surgery. A Pilot Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417788
• Other study ID #: CIR-ECL-2018-09
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mouth, Edentulous
• Partially Edentulous Patients

Intervention

Device:
• Dental implant placement
Dental implant placement guided by Navident® (ClaroNav Inc., Toronto, Canada)

Procedure:
• Static guided implant placement
Dental implant placement guided by a stereolithographic pilot drill guide.

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat Del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View 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. — View 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. — View Citation

Doyle DJ, Hendrix JM, Garmon EH. American Society of Anesthesiologists Classification. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/ — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant placement accuracy at the implant platform level	Implant placement accuracy compared with the implant planning. Expressed in mm.	The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Primary	Implant placement accuracy at the implant apex level	Implant placement accuracy compared with the implant planning. Expressed in mm.	The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Primary	Implant placement accuracy at an angular evel	Implant placement accuracy compared with the implant planning. Expressed in degrees.	The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Primary	Implant placement accuracy at the vertical plane.	Implant placement accuracy compared with the implant planning. Expressed in mm.	The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.