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Completed

NCT Number: NCT00323466

A Study of the Effect on Oro-dental Complications of Intensity Modulated Radiotherapy (IMRT) Versus Conventional Radiotherapy in Patients With Cancer of the Head or Neck

Study to investigate the effect of two types of radiotherapy on saliva: IMRT versus conventional radiotherapy.

In each group, one part will receive normal dental preventive treatment. The other part will use products for treatment of dry mouth (Biotene gamma).

Both anorganic and organic components of the saliva will be studied at different time points, combined with bacterial swabs.

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Key information

Conditions

Cancer: Head or Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years old
  • Cancer of head or neck

Exclusion criteria

-

Treatment and study plan

IMRT versus conventional radiotherapy

Procedure

Comparing MRT versus conventional radiotherapy

Primary outcomes

  1. Volume of saliva

    Time frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)

  2. Quality of saliva

    Time frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)

  3. Oral flora

    Time frame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 9, 2006
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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