Chlorhexidine Gel Therapy for Cariogenic Oral Microflora

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find out if 1% chlorhexidine gluconate gel will decrease the amount of bacteria that causes tooth decay. Whether the gel is acceptable to patients will also be studied.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

Inclusion:

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 examination.

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.