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Chlorhexidine Gel Therapy for Cariogenic Oral Microflora in Irradiated Head and Neck Cancer Patients

Phase 1
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

Chlorhexidine Gel Therapy for Cariogenic Oral Microflora in Irradiated Head and Neck Cancer Patients

1% chlorhexidine gluconate gel is an alcohol-free, raspberry-flavored brush-on gel. It is
designed to decrease the amount of bacteria found in your mouth that can cause tooth decay.

Within a month, if you are found to be eligible to take part in this study, researchers will
use custom dental trays designed for you, in order to deliver the chlorhexidine gel.
During your next visit to the dental clinic, researchers will place these custom dental
trays and the gel in your mouth for about 5 minutes. Over the next 30 minutes, the gel will
be applied one more time. The dentist will also chart your decayed, missing, and filled
teeth in a dentist chart during this visit. The dentist will also check the soft tissues of
your mouth. You will have an office visit the next day (Day 2) to see if you had any side
effects to the chlorhexidine gel.

These trays will be coated with the gel every 2 weeks, for a 12-week period. You will hold
the trays with the gel in your mouth for at least 5 minutes, usually at night or in the
morning. You should not eat or drink during these 5 minutes in order to increase the
effectiveness of the gel on your teeth. You will apply the gel at home, for one 5-minute
application, on Weeks 2, 4, 8 and 10. You will be given a diary to list each time that you
use the gel at home, and to list if you experience any side effects. You will have office
visits on Weeks 6 and 12. The dentist will floss between all of your teeth during these
office visits. You will also use the gel, for two 5-minute applications, during these
office visits. You will also need to bring the completed diary to each office visit.

When you return for the office visit, a dentist or dental hygienist will then collect a
sample of your dental plaque (a film of mucous and bacteria found on your teeth's surface)
by scraping plaque from the surface of your teeth and flossing between your teeth, and then
placing the plaque in a small test tube to check for bacteria. The dentist will not scrape
below the gums. These plaque samples will be collected on Weeks 6 and 12 at the dental

Once the gel application period is over, you will need to return to the dental clinic for
plaque sample scrapings at Weeks 16 and 20 so that researchers can check to see if the
bacteria is growing again.

You will also complete two questionnaires during your baseline, Week 6, and Week 12 visits
to describe your experience with the use of the gel and your side effects from radiation

Once your last plaque sample scraping has been collected on Week 20, your participation in
this study will be complete. The dentist or dental hygienist will floss between all of your
teeth and your decayed, missing, and filled teeth will be charted in a dentist chart during
the Week 20 office visit. You will be taken off study if intolerable side effects occur.

This is an investigational study. 1% chlorhexidine gluconate is not FDA approved or
commercially available. It has been authorized for use in research only. About 50 patients
will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:


1. Patients who have undergone radiation treatment to the head and neck at U.T. M. D.
Anderson Cancer Center for oral cavity or oropharyngeal cancer (base of tongue and
tonsil) and have recent documented caries, within 8 weeks, on routine oral

2. Patients with >/= 10 teeth.

3. Patients with >/= 100,000 CFU/ ml S. mutans in the baseline microbiological sample
(i.e., supragingival curette sampling).

Exclusion Criteria:

1. Patients using antibiotics in the past 4 weeks. (Note: A subject may have antibiotics
administered during the study evaluation period, for unforeseen medical reasons. The
patients will not be removed from the study and the plaque samples will be evaluated
for descriptive assessment with the concomitant medication(s) recorded to determine
if changes between the subject's samples were globally outside the range of changes
for the population as a whole.)

2. Patients using chlorhexidine gluconate or antimicrobial rinses in past 2 weeks.

3. Patients under the age of 18.

4. Patients unable to return to dental clinic over the 20-week study period.

5. Patients with a known allergy to Chlorhexidine.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Microbiology Assessments (Evaluation of colony forming units of Streptococcus mutans, Lactobacilli spp. and Actinomyces naeslundii and Actinomyces viscous)

Outcome Description:

At baseline, after initial drug administration, and on weeks 6 and 12 of drug administration; and weeks 16 and 20 after cessation of drug application.

Outcome Time Frame:

20 weeks

Safety Issue:


Principal Investigator

Rhonda F. Jacob, MS, BS, DDS

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Chlorhexidine
  • Chlorhexidine Gel Therapy
  • 1% chlorhexidine gluconate gel
  • Cariogenic Oral Microflora
  • Irradiated Head and Neck Cancer Patients
  • caries-forming organisms
  • Radiation treatment
  • Mouth Cancer
  • Throat Cancer
  • Tooth decay
  • Head and Neck Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030