Chlorhexidine Gel Therapy for Cariogenic Oral Microflora
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.
Description
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.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will place about 2 tablespoons of salty mouthwash in your mouth for 15 seconds. A dentist 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 then placing it in a small test tube to check for bacteria. This sample will be used to find out how much of the most common bacteria (S. Mutans) is present in your mouth. The dentist will not scrape below the gums. The dentist will also floss between all of your teeth and your decayed, missing and filled teeth will be charted in a dentist chart. This screening visit will take about 20 minutes. The sample will be taken to Dr. Dimitrios Kontoyiannis' laboratories, located at M.D. Anderson Cancer Center, for analysis.
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. The 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. 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 1 time, every 2 weeks, for a 12-week period. You will hold the trays with the gel in your mouth for 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 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. You will use the gel during these office visits. You will also need to bring the completed diary to each office visit.
A dentist 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 then placing it in a small test tube to check for bacteria. The dentist will not scrape below the gums. These samples will also be collected on Weeks 6 and 12 at the dental clinic.
Once the gel application period is over, you will need to return to the 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 treatment.
Once your last plaque sample scraping has been collected on Week 20, your participation in this study will be complete and your decayed, missing, and filled teeth will be charted again. 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 M. D. Anderson.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Conditions
Head and Neck Cancer
Intervention
1% Chlorhexidine Gluconate Gel, Surveys
Location
UT MD Anderson Cancer Center
Houston
Texas
United States
77030
Status
Recruiting
Source
M.D. Anderson Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01036412
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Head And Neck Neoplasms
Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)
Antimony Sodium Gluconate
Antimony complex where the metal may exist in either the pentavalent or trivalent states. The pentavalent gluconate is used in leishmaniasis. The trivalent gluconate is most frequently used in schistosomiasis.
Neck Dissection
Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.
Rhabdomyosarcoma, Embryonal
A form of RHABDOMYOSARCOMA arising primarily in the head and neck, especially the orbit, of children below the age of 10. The cells are smaller than those of other rhabdomyosarcomas and are of two basic cell types: spindle cells and round cells. This cancer is highly sensitive to chemotherapy and has a high cure rate with multi-modality therapy. (From Holland et al., Cancer Medicine, 3d ed, p2188)
Torticollis
A symptom, not a disease, of a twisted neck. In most instances, the head is tipped toward one side and the chin rotated toward the other. The involuntary muscle contractions in the neck region of patients with torticollis can be due to congenital defects, trauma, inflammation, tumors, and neurological or other factors.
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