Clinical trial · Interventional
Chlorhexidine Gel Therapy for Cariogenic Oral Microflora
Chlorhexidine Gel Therapy for Cariogenic Oral Microflora in Irradiated Head and Neck Cancer Patients
NCT01036412CI-TRIAL-00020992completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1% Chlorhexidine Gluconate Gel | Drug | — | UNRESOLVED |
| Surveys | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chlorhexidine Gel Therapy
- description
- 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
- interventionNames
- Drug: 1% Chlorhexidine Gluconate Gel
- Behavioral: Surveys
Primary outcomes (1)
- measure
- Microbiology Assessments (Evaluation of colony forming units of Streptococcus mutans, Lactobacilli spp. and Actinomyces naeslundii and Actinomyces viscous)
- timeFrame
- 20 weeks
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.