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Mouth, EdentulousNERVIMPLANTNCT05667389

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

An observational study of Mouth, Edentulous, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mouth, Edentulous
How many people
240 participants
Where
1 siteFrance
Study dates
Dec 2022to Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Non-French speaking person

Trial locations and contacts

1 site in 1 country.

Adeline BRAUD, MD, PhD contact

01 40 19 39 43 ext. +33

adeline.braud@aphp.fr

Rufino FELIZARDO, MD, PhD contact

01 40 19 39 60 ext. +33

rufino.felizardo@aphp.fr

France1 site
  • Hospital Rotschild, Odontology Department

    Paris

    Rufino FELIZARDO, MD, PhD, 01 40 19 39 60 ext. +33, rufino.felizardo@aphp.fr

    Laria-Clotilde CARRA, MD, PhD, 01 40 19 39 60 ext. +33, mariaclotilde.carra@aphp.fr

Other trials in France

About this study

Official title: Evaluation of the Vascular and Neural Elements Located in the Symphyseal Region Before Implant Surgery: a Retrospective Study of Cone Beam Computed Tomography (CBCT) Scans of the Face Performed on Totally Edentulous Patients in the Odontology Department of the Rothschild Hospital

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.

Read the detailed description

The placement of dental implants in the anterior mandibular region is considered a rather safe and predictable procedure because this region has a limited number of neurovascular elements, a relatively extensive vestibular and lingual cortical bone structure, and dense trabecular bone providing high primary stability and excellent implant survival. However, this anatomical region is not free of risks, some of which are associated with potentially fatal complications (cases of death following a hemorrhagic accident have for example been described). Many clinical cases thus illustrate complications of implant surgery in the symphyseal region such as nerve damage, bone fractures, infections, and bleeding during or after the placement of the dental implant.

Implant surgery can indeed generate nerve damage according to different mechanisms by nerve compression or dilaceration by direct contact of the drill and/or the implant with the nerve compression linked to peri-implant edema or compressed bone debris at the bottom of the drill site.irritation by release of inflammatory mediators from adjacent inflamed or necrotic bone or thermal injury (heating during implant drilling). Nerve injury is clinically manifested by symptoms of varying stage and severity depending on the severity of the injury caused to the nerve. Clinically, nerve damage to the sensory afferents of the NAI can generate sensory dysfunction such as paresthesia (abnormal sensitivity), hypoesthesia (decreased sensitivity), hyperesthesia (increased sensitivity), dysesthesia (unpleasant sensitivity that may result in pain ) or even anesthesia (complete loss of sensitivity) localized to the territory of innervation of the injured nerve. From the epidemiological point of view, the frequency of such complications would be estimated between 0 and 24% for transient lesions and between 0 and 11% for irreversible lesions. Two retrospective studies carried out with more than 1300 patients with iatrogenic lesions of peripheral trigeminal afferents observed that 13% presented with pain following implant surgery.Implant surgery would thus be the second cause of NAI lesions (18%), after wisdom tooth extraction .

In implantology, vascular effraction is most often observed after perforation of the lingual cortex of the symphyseal or posterior regions , the drill causing the tearing of the underlying vascular structures. A fracture of the internal cortex during implant surgical procedures thus increases the risk of bleeding. At the level of the symphyseal region, the lesion of the sublingual artery can for example be responsible for abundant bleeding or intraoperative hemorrhage, and/or hematoma of the floor of the mouth per or postoperative , with a risk of obstruction of the upper digestive airways. From a clinical point of view, it seems very complicated to be able to establish with certainty the origin of bleeding from the floor of the mouth and only endovascular angiography can determine its origin, which complicates the management of this type of complication.

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 the avulsion of the anterior teeth and the 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 which could constitute unfavorable anatomical conditions with damage to vascular and/or nervous elements during implant surgical procedures.

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 within a completely edentulous population for which the anatomy has been documented in a three-dimensional way before the placement of dental implants. A better knowledge of the anatomy and anatomical variations affecting the edentulous symphyseal region would allow identification of patients for whom there is a proximity between the implantation sites and the vascular and nervous elements in the edentulous symphyseal zone.

From the information collected in the clinical files (clinical and imaging data) of patients who consulted the Odontology department of the Rothschild Hospital for an imaging assessment by cone-beam computed tomography before the installation of dental implant, the investigator want to perform a descriptive analysis of the characteristics of the vascular and nervous elements (location, dimensions, anatomical relationships) located in the edentulous symphyseal area (main objective) and to specify the anatomical characteristics (height and bone thickness of the edentulous symphyseal area.

The files of totally edentulous patients who consulted the Odontology department of the Rothschild Hospital, between September 2013 and March 2021, for an imaging assessment by volume cone beam computed tomography before the placement of dental implants will be selected. Within the imaging unit, about thirty patients consult on average per year for pre-implant cone beam computed tomography imaging. Over the period 2013-2021, the population studied is thus estimated at approximately 240 patients.

A good knowledge and evaluation of the vascular and nervous elements during the pre-implant assessment is a prerequisite for limiting the risks of per and post-operative complications. If the anatomy of the symphyseal area is rather well described in the literature in dentate subjects, few data remain available in totally edentulous patients for whom the avulsion of the teeth and the bone resorption could lead to anatomical modifications impacting the elements vasculo-nervous traveling in the edentulous symphyseal zone.

Our working hypothesis is that the vascular and nervous elements traveling in the symphyseal region of edentulous patients are numerous and often located near the implantation sites in the symphyseal region. The study project will make it possible to document and enrich anatomical knowledge by specifying the characteristics of the vasculo-nervous elements progressing at the level of the symphyseal zone in a series of totally edentulous patients followed in the department for a pre-treatment imaging assessment. implant. The analysis of these epidemiological, medical and anatomical data from the clinical records of patients will also make it possible to specify the anatomical relationships between the vascular-nervous elements and the planned implantation sites.

Keywords
Cone beam computed tomography imaging, Edentulous mandibule, Symphyseal area, Vascular, Nervous, Implant
Medical subject headings
Mouth, Edentulous

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number and localisation of foramina location

    Measured: Before implant placement (one day)

Secondary outcomes (5)
  1. Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : diameter

    The diameter of the incisor canal

    Measured: Before implant placement (one day)

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

    The mesio-distal dimension of the incisal canal

    Measured: Before implant placement (one day)

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

    The diameter of the opening of the lingual foramen from the end of the lingual canal

    Measured: Before implant placement (one day)

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

    The vestibular and lingual position of the tongue canal

    Measured: Before implant placement (one day)

  5. Anatomical characteristics of the edentulous symphyseal area.

    Height and bone thickness within the symphyseal mandibule

    Measured: Before implant placement (one day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study startDec 2022 (estimated)
  3. Primary completionFeb 2023 (estimated)
  4. Study completionFeb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05667389
Sponsor's protocol ID
APHP211120
Acronym
NERVIMPLANT
Status last verified
Dec 2022
First submitted
21 Nov 2022
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Mouth, Edentulous, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Adeline BRAUD, MD, PhD (01 40 19 39 43 ext. +33, adeline.braud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characteristics of the vascular and nervous elements located in the edentulous symphyseal area (time frame: Before implant placement (one day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.

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