## Protocol Section
### Identification Module
**NCT ID:** NCT06417788

**Brief Title:** Dynamic Guided Implant Surgery VS Static Guided Surgery.

**Official Title:** Dynamic Guided Implant Surgery VS Static Guided Surgery. A Pilot Randomized Clinical Trial.

#### Organization Study ID Info
**ID:** CIR-ECL-2018-09
#### Organization
**Class:** OTHER
**Full Name:** Universitat Internacional de Catalunya
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitat Internacional de Catalunya

#### Responsible Party

**Investigator Affiliation:** Universitat Internacional de Catalunya

**Investigator Full Name:** Jordi Marquès Guasch

**Investigator Title:** Jordi marques Guasch

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Partially Edentulous Patients

- Bone Crest of at Least 10 mm Length and 6 mm Width

- Patients of at Least 18 Years Old

### Design Module

#### Design Info

**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)

##### Masking Info

**Masking:** SINGLE

**Masking Description:** 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.

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** DEVICE_FEASIBILITY

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Dental implant placement

**Label:** Test group or Dynamic guided group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Procedure: Static guided implant placement

**Label:** Control group or Static guided group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Test group or Dynamic guided group

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

**Name:** Dental implant placement

**Other Names:**

- dynamic guided implant placement

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control group or Static guided group

**Description:** Dental implant placement guided by a stereolithographic pilot drill guide.

**Name:** Static guided implant placement

**Other Names:**

- control group

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Implant placement accuracy compared with the implant planning. Expressed in mm.

**Measure:** Implant placement accuracy at the implant platform level

**Time Frame:** The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.

**Description:** Implant placement accuracy compared with the implant planning. Expressed in mm.

**Measure:** Implant placement accuracy at the implant apex level

**Time Frame:** The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.

**Description:** Implant placement accuracy compared with the implant planning. Expressed in degrees.

**Measure:** Implant placement accuracy at an angular evel

**Time Frame:** The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.

**Description:** Implant placement accuracy compared with the implant planning. Expressed in mm.

**Measure:** Implant placement accuracy at the vertical plane.

**Time Frame:** The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sant Cugat Del Vallès

**Contacts:**

***Contact 1:***

- **Email:** jmarques@uic.es

- **Name:** Marques Guasch

- **Phone:** +447453802813

- **Role:** CONTACT

***Contact 2:***

- **Email:** jgargallo@uic.es

- **Name:** Gargallo Albiol

- **Phone:** +34637434270

- **Role:** CONTACT

**Country:** Spain

**Facility:** Universitat Internacional de Catalunya

**State:** Barcelona

**Status:** RECRUITING

**Zip:** 08195

### IPD Sharing Statement Module

**Description:** Plan to publish the IPD.

**Info Types:**

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** when the data is available during the publication process

### References Module

#### 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.

**PMID:** 24837492

**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.

**PMID:** 23062136

**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.

**PMID:** 23062137

**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.

**PMID:** 27643585

**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.

**PMID:** 28000275

**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.

**PMID:** 29310817

**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.

**PMID:** 26452429

**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.

**PMID:** 4500182

**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/

**PMID:** 28722969

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000014076

- Term: Tooth Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12026

- Name: Mouth, Edentulous

- Relevance: HIGH

- As Found: Edentulous

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009066

- Term: Mouth, Edentulous

### Misc Info Module

- Version Holder: 2024-05-31
