Evaluation of the Vascular and Neural Elements Located in the Symphyseal Region Before Implant Surgery

NCT05667389 | Unknown

• 1 other identifier: APHP211120
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The placement of implants in the symphyseal region is common, especially in the treatment of totally edentulous patients. Some implant surgical procedures may however be responsible for lesions of the vascular and nervous elements in the symphyseal region. The prevention of vascular and nervous accidents during or after implant surgery is based on the identification of vascular and nervous elements. Although the anatomy of the symphyseal region is rather well described in the literature, the data concerning totally edentulous patients remains fragmented. These suggest that tooth avulsion and bone resorption have an influence on the anatomy of the mandibular region, and of the vascular and nervous elements traveling in the anterior mandibular part. These modifications would be responsible for individual anatomical variations. In order to test this hypothesis, the investigator wish to evaluate the anatomical characteristics of the vascular and nervous elements located in the symphyseal region, retrospectively, of a totally edentulous population for which the anatomy was documented in a three-dimensional way from 2013 to 2021 before the placement of dental implants.

Conditions

Mouth, Edentulous

Keywords

Cone beam computed tomography imaging; Edentulous mandibule; Symphyseal area; Vascular; Nervous; Implant

Outcome Measures

Primary Outcomes (1)

• Characteristics of the vascular and nervous elements located in the edentulous symphyseal area

  Number and localisation of foramina location

  Before implant placement (one day)

Secondary Outcomes (5)

• Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : diameter

  Before implant placement (one day)

• Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : mesio-distal dimension

  Before implant placement (one day)

• Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : diameter of the opening

  Before implant placement (one day)

• Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : vestibular and lingual position

  Before implant placement (one day)

• Anatomical characteristics of the edentulous symphyseal area.

  Before implant placement (one day)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Totally edentulous patients that have consulted in the odontology department of Rothschild Hospital from September 2013 to March 2021 for an imaging assessment by Cone Beam Computed Tomography before implant placement.

You may qualify if:

• Adult patients aged \> 18 years old, totally edentulous, that have benefited from a CBCT examination in the odontology department with a view to implantation in the symphyseal region from 2013 to 2021
• Not opposed to the use of their data

You may not qualify if:

• Non-French speaking person

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Rotschild, Odontology Department

Paris, France

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Adeline BRAUD, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeline BRAUD, MD, PhD

CONTACT

01 40 19 39 43; adeline.braud@aphp.fr

Rufino FELIZARDO, MD, PhD

CONTACT

01 40 19 39 60; rufino.felizardo@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 28, 2022
• Study Start: December 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

FR (1)