NCT03936881

Brief Summary

Observational study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

May 6, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

April 30, 2019

Last Update Submit

September 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of calcifications of the carotid area

    Calcifications of the carotid as recorded on the orthopantomogram of the patient

    During the realization of the orthopantomogram (between 1 September 2018 and 31 December 2018)

Secondary Outcomes (2)

  • Presence or absence of a cardiovascular pathology

    During the consultation at the Dental Care Centre (between 1 September 2018 and 31 December 2018)

  • Presence or absence of moderate to severe alveolysis

    During the consultation at the Dental Care Centre (between 1 September 2018 and 31 December 2018)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years of age who presented themselves at the Dental Care Centre of the Rennes University Hospital between 1 September 2018 and 31 December 2018

You may qualify if:

  • Adult patient (18 years of age or older) attending the dental care centre at the Rennes University Hospital;
  • Who had an orthopantomogram radiological examination at the Rennes Dental Care Centre between 1 September 2018 and 31 December 2018;
  • Having agreed to the use of its data for teaching or publication purposes.

You may not qualify if:

  • Orthopantomogram not usable, not allowing to visualize the sub-mandibular region (due to poor patient positioning);
  • Persons of full age who are subject to legal protection (protection of justice, guardianship, guardianship), persons deprived of their liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Guy CATHELINEAU

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 3, 2019

Study Start

May 6, 2019

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations