Head and Neck CancerPhase 1NCT01036412
Chlorhexidine Gel Therapy for Cariogenic Oral Microflora
A Phase 1 study testing 1% Chlorhexidine Gluconate Gel and Surveys in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 1% Chlorhexidine Gluconate Gel and Surveys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chlorhexidine Gel Therapy for Cariogenic Oral Microflora in Irradiated Head and Neck Cancer Patients
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.
Read the detailed 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.
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 clinic.
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 treatment.
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.
- Conditions
- Head and Neck Cancer
- Being tested
- 1% Chlorhexidine Gluconate Gel, Surveys
- 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
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Chlorhexidine Gluconate GelDrug
Also called Chlorhexidine Gel
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).
SurveysBehavioural
Also called Questionnaire
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: 1% Chlorhexidine Gluconate Gel; Behavioral: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rhonda F. Jacob, MS, BS, DDS, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036412
- Sponsor's protocol ID
- 2005-0456
- Status last verified
- Aug 2012
- First submitted
- 17 Dec 2009
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine Gel Therapy for Cariogenic Oral Microflora in Irradiated Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01036412
- Acronym / sponsor ID
- 2005-0456
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
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 clinic.
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 treatment.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Gel Therapy | Experimental | Drug: 1% Chlorhexidine Gluconate Gel, Behavioral: SurveysFollowing 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% Chlorhexidine Gluconate GelAlso: Chlorhexidine GelFollowing 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). | Drug | Chlorhexidine Gel Therapy |
| SurveysAlso: QuestionnaireM. 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. | Behavioural | Chlorhexidine Gel Therapy |
Primary outcome
Microbiology Assessments (Evaluation of colony forming units of Streptococcus mutans, Lactobacilli spp. and Actinomyces naeslundii and Actinomyces viscous)
Time frame: 20 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Head and Neck Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
Active, not recruitingPhase 2
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
Head and Neck Cancer
RecruitingPhase 2
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
Soft Tissue Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhonda F. Jacob, MS, BS, DDS study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1% Chlorhexidine Gluconate Gel and Surveys in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiology Assessments (Evaluation of colony forming units of Streptococcus mutans, Lactobacilli spp. and Actinomyces naeslundii and Actinomyces viscous) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.