Dynamic Guided Implant Surgery VS Static Guided Surgery.

NCT ID: NCT06417788

Last Updated: 2024-05-22

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2024-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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Test group or Dynamic guided group

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

Group Type EXPERIMENTAL

Dental implant placement

Intervention Type DEVICE

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

Control group or Static guided group

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

Group Type ACTIVE_COMPARATOR

Static guided implant placement

Intervention Type PROCEDURE

Dental implant placement guided by a stereolithographic pilot drill guide.

Interventions

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Dental implant placement

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

Intervention Type DEVICE

Static guided implant placement

Dental implant placement guided by a stereolithographic pilot drill guide.

Intervention Type PROCEDURE

Other Intervention Names

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dynamic guided implant placement control group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Jordi Marquès Guasch

Jordi marques Guasch

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Marques Guasch

Role: primary

+447453802813

Gargallo Albiol

Role: backup

+34637434270

References

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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.

Reference Type BACKGROUND
PMID: 24837492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23062136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23062137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27643585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28000275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29310817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26452429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4500182 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 28722969 (View on PubMed)

Other Identifiers

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CIR-ECL-2018-09

Identifier Type: -

Identifier Source: org_study_id

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