Dynamic Guided Implant Surgery VS Static Guided Surgery.

NCT06417788 | Recruiting

• 1 other identifier: CIR-ECL-2018-09
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Partially Edentulous Patients; Bone Crest of at Least 10 mm Length and 6 mm Width; Patients of at Least 18 Years Old

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Test group or Dynamic guided group

EXPERIMENTAL

in this arm, the position and angulation of the implant in the patient's mouth will be guided by a dynamic guided system.

Device: Dental implant placement

Control group or Static guided group

ACTIVE COMPARATOR

In this arm, the position and angulation of the implant in the patient's mouth will be guided by a stereolitographic pilot drill guide.

Procedure: Static guided implant placement

Interventions

Dental implant placement DEVICE

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

Also known as: dynamic guided implant placement

Test group or Dynamic guided group

Static guided implant placement PROCEDURE

Dental implant placement guided by a stereolithographic pilot drill guide.

Also known as: control group

Control group or Static guided group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 24837492 BACKGROUND

• 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.

  PMID: 23062136 BACKGROUND

• 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.

  PMID: 23062137 BACKGROUND

• 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.

  PMID: 27643585 BACKGROUND

• 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.

  PMID: 28000275 BACKGROUND

• 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.

  PMID: 29310817 BACKGROUND

• 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.

  PMID: 26452429 BACKGROUND

• 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.

  PMID: 4500182 BACKGROUND

• 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/

  PMID: 28722969 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Due to the nature of the treatment, it is impossible to mask the treatment from the participant and the care provider. However, the data for analysis will be masked to the investigator responsible for assessing the accuracy of each implant placement system.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jordi marques Guasch

Model Details: 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)

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: May 30, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: when the data is available during the publication process

Locations

ES (1)