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.
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.
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
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.
- Conditions
- Mouth, Edentulous
- 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.
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)
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)
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)
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)
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)
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.
- First posted28 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth, EdentulousStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline BRAUD, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05667389
- Acronym / sponsor ID
- NERVIMPLANT / APHP211120
- Conditions
- Mouth, Edentulous
- Keywords
- Cone beam computed tomography imaging, Edentulous mandibule, Symphyseal area, Vascular, Nervous, Implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Non-French speaking person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics of the vascular and nervous elements located in the edentulous symphyseal area
Time frame: Before implant placement (one day)
Number and localisation of foramina location
5 secondary outcomes
Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : diameter
Time frame: Before implant placement (one day)
Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : mesio-distal dimension
Time frame: Before implant placement (one day)
Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : diameter of the opening
Time frame: Before implant placement (one day)
Characteristics of the vascular and nervous elements located in the edentulous symphyseal area : vestibular and lingual position
Time frame: Before implant placement (one day)
Anatomical characteristics of the edentulous symphyseal area.
Time frame: Before implant placement (one day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline BRAUD, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.