Other Clinical Trial - Accompaniment of Patients by Dental Assistants in

Clinical Trial Summary

Feasibility, prospective, monocentric study aiming to evaluate the interest of a written information guide, given and explained by the dental assistant, on the improvement of the oral hygiene of patients with ORL cancer at 3 months post-radiotherapy. The study will be conducted on a population of 44 patients with ORL cancer requiring radiation treatment. Each patient will be followed during 3 months post-radiotherapy (follow-up for up to 12 months post-inclusion).

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05494970
Study type	Observational
Source	Institut Claudius Regaud
Contact
Status	Completed
Phase
Start date	October 13, 2022
Completion date	January 30, 2024

Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment. — RadioT HBD

Clinical Trial Summary

Clinical Trial Description

Study Design