NCT04675203

Brief Summary

The main objective is to study the expression of molecules involved in tooth morphogenesis and eruption in healthy patients, and then to compare them with the results in patients with abnormalities of eruption (results obtained via a collection of biological samples of rare diseases already authorized).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

December 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

December 14, 2020

Last Update Submit

March 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Expression and localization of molecules involved in tooth eruption

    Tissues are collected at the time of surgery and transferred during the day to the laboratory for analysis

    During surgery

Study Arms (1)

Normal tooth eruption

Procedure: Tooth extraction

Interventions

Tooth extraction

Normal tooth eruption

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic (Hôpitaux Universitaires de Strasbourg, France)

You may qualify if:

  • Patient over 12 years old who has given his consent
  • Patient whose legal representatives have given their consent for the use of operating waste destined for incineration
  • Patient undergoing oral surgery at the University Hospitals of Strasbourg, at the origin of the production of surgical waste such as teeth and bone fragments
  • Patient affiliated to a social security system

You may not qualify if:

  • Refusal to participate
  • Patient with chronic systemic pathology
  • Patient under long-term drug treatment
  • Patient presenting a rare pathology with oral manifestation
  • Patient with a history of chemotherapy or head and neck radiotherapy
  • Non-French speaking patient / inability to give informed information
  • Patient under guardianship, curatorship or legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

teeth and bone fragments of the jaw

MeSH Terms

Conditions

Exanthema

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 19, 2020

Study Start

March 1, 2021

Primary Completion

March 1, 2021

Study Completion

January 1, 2023

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations