Chlorhexidine Gel Therapy for Cariogenic Oral Microflora

NCT01036412 | Completed Phase 1

• 1 other identifier: 2005-0456
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  20 weeks

Study Arms (1)

Chlorhexidine Gel Therapy

EXPERIMENTAL

Following 2 x 5-minute applications of 2.5 ml in clinic, 2 x 5.0 ml syringes of 1% chlorhexidine gluconate gel, self-administered for a 5-minute application Week 2 \& Week 4

Drug: 1% Chlorhexidine Gluconate Gel; Behavioral: Surveys

Interventions

1% Chlorhexidine Gluconate Gel DRUG

Following two 2.5 ml 5-minute applications performed in clinic on Day 1, 2 x 5.0 ml syringes of chlorhexidine gel self-administered for one 5-minute application using the custom-made carriers carriers on week 2 (12-14 days from baseline visit study drug administration) and week 4 (12-14 days from Week 2 study drug administration).

Also known as: Chlorhexidine Gel

Chlorhexidine Gel Therapy

Surveys BEHAVIORAL

M. D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionnaire, in addition to a 2nd subjective, study-specific questionnaire administered during visit taking about 5 minutes to complete each assessment.

Also known as: Questionnaire

Chlorhexidine Gel Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with \>/= 10 teeth.
• Patients with \>/= 100,000 CFU/ ml S. mutans in the baseline microbiological sample (i.e., supragingival curette sampling).

You may not qualify if:

• 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.)
• Patients using chlorhexidine gluconate or antimicrobial rinses in past 2 weeks.
• Patients under the age of 18.
• Patients unable to return to dental clinic over the 20-week study period.
• Patients with a known allergy to Chlorhexidine.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms; Dental Caries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rhonda F. Jacob, MS, BS, DDS

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 19, 2016

Record last verified: 2012-08

Locations

US (1)