Impact of Compliance With Fluoride Use on Caries Incidence After Cancer Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/17/2018 |
| Start Date: | August 29, 2017 |
| End Date: | May 31, 2019 |
| Contact: | Seena Patel, DMD. MPH |
| Email: | sbpatel@atsu.edu |
| Phone: | 480-248-8107 |
Approximately 40 people will participate in this study. This study will compare two different
methods of fluoride application. Both methods are currently used in dental practice and both
have been shown to be effective. If the participant chooses to participate in this study,
participant will be asked to either wear a small tray that has been custom made to fit into
the mouth into which fluoride is placed and worn for 5 minutes at bedtime, or participant
will be asked to brush fluoride onto the teeth for 2 minutes at bedtime. Participant will be
randomly assigned to use one of these methods of fluoride application: participant will not
be allowed to choose which method of application you prefer. Participant will be asked to use
fluoride every night while enrolled in the study. The fluoride that is used in the study is
approved by the United States Food and Drug Administration and is commercially available with
a prescription. After the study is over, participant will need to continue to use fluoride
every night for life to help reduce the risk for dental cavities in the future.
During the study, participant will receive a dental examination every 3 months for a total of
4 study visits over the period of 1 year. This visit will consist of a dental examination to
identify any new cavities and instructions for fluoride use. Participant will also be asked
to complete a written log to document daily fluoride use and to give feedback about
compliance with fluoride use.
methods of fluoride application. Both methods are currently used in dental practice and both
have been shown to be effective. If the participant chooses to participate in this study,
participant will be asked to either wear a small tray that has been custom made to fit into
the mouth into which fluoride is placed and worn for 5 minutes at bedtime, or participant
will be asked to brush fluoride onto the teeth for 2 minutes at bedtime. Participant will be
randomly assigned to use one of these methods of fluoride application: participant will not
be allowed to choose which method of application you prefer. Participant will be asked to use
fluoride every night while enrolled in the study. The fluoride that is used in the study is
approved by the United States Food and Drug Administration and is commercially available with
a prescription. After the study is over, participant will need to continue to use fluoride
every night for life to help reduce the risk for dental cavities in the future.
During the study, participant will receive a dental examination every 3 months for a total of
4 study visits over the period of 1 year. This visit will consist of a dental examination to
identify any new cavities and instructions for fluoride use. Participant will also be asked
to complete a written log to document daily fluoride use and to give feedback about
compliance with fluoride use.
This research proposal is unique in that it compares two different methods of applying
neutral sodium fluoride to prevent dental caries and improve compliance in this at-risk
population. Given that compliance with use of fluoride trays has historically been poor,
there is controversy as to which application method is best. Further, the optimal dosage
regimen is unknown. Clarification is needed to support best practices.
Data from the proposed study will help to identify an effective and tolerated form of
fluoride delivery in patients undergoing head and neck radiation therapy. If our hypotheses
are supported, additional studies will be undertaken with a larger sample size, and expanded
to include patients with head and neck cancers treated with chemotherapy or a combination of
cancer therapies.
All patients will undergo an initial dental visit, which will consist of medical consultation
with the patient's oncologist and standard dental and radiographic examinations. Patients
will return to have existing dental disease treated (eg. caries, gingival disease,
extractions). When treatment is complete, they will be invited to participate in the study.
The Screening Form will be used to confirm eligibility.
Study Visit #1 (Baseline) After obtaining consent, subjects will be randomly assigned to
receive fluoride therapy with either custom trays (Tray group) or by application with a
toothbrush (Brush group). Each subject will undergo a basic dental examination for
identification of new carious lesions. Visit #1 is the baseline, with a new caries score of
zero. Photographs will be taken of the subject's mouth and instructions for fluoride therapy
will be given.
Tray group: The subject will have custom vinyl vacuform fluoride trays made using an in-house
laboratory. They will be instructed to apply a "ribbon" of fluoride gel into each tray, and
then to wear each tray for 5 minutes, one tray at a time, after which the subject will
expectorate any remaining fluoride from the mouth.
Brush group: The subject will be instructed to apply a "ribbon" of fluoride gel onto the
toothbrush provided (Colgate Wave Sensitive) and to brush with the fluoride for 2 minutes at
bedtime.
Both groups: The subject may not rinse, eat, or drink for 30 minutes after the fluoride
treatment.
All subjects will be instructed to perform their fluoride therapy at bedtime and to document
the date and time of treatment on the Monthly Fluoride Log. All subjects will be provided
with 1.1% neutral sodium fluoride (PreviDent®) gel for the duration of the study. All
subjects will be instructed to return their monthly fluoride logs and any remaining fluoride
at each study visit.
Subjects will return for a follow-up examination at 3, 6, 9, and 12 months from the first
study visit. At each visit, the following procedures will be conducted:
- Update medical history
- Take photographs
- Conduct examination for caries
- Assess compliance with fluoride therapy
- Collect fluoride log for previous 3 months
- Dispense new fluoride log
- Collect and weigh returned fluoride tube
- Weigh and dispense new fluoride tube
- Dispense new toothbrush (Brush group only)
Subjects will be scheduled to immediately return to have any new carious lesions filled.
To evaluate compliance, subjects will be asked about their fluoride use according to standard
methods utilized by other experts in the field. High compliance is defined as daily use; low
compliance is defined as two to three times per week; not compliant is defined as less than
two times per week.
To evaluate caries incidence, the number of surfaces per tooth on which new caries appear
will be documented on the Caries Assessment Form. Caries will be scored using the
International Caries Classification and Management System criteria for clinical research.
Surfaces will be scored as either I (no obvious decay) or II (obvious decay). Bitewing
radiographs and periapical films (as needed) will be taken at 6 and 12 months after the
initial examination visit.
Descriptive statistics, including means (standard deviations) or counts (percentages), as
appropriate, will be used to summarize baseline demographic and clinical characteristics of
the two groups.
neutral sodium fluoride to prevent dental caries and improve compliance in this at-risk
population. Given that compliance with use of fluoride trays has historically been poor,
there is controversy as to which application method is best. Further, the optimal dosage
regimen is unknown. Clarification is needed to support best practices.
Data from the proposed study will help to identify an effective and tolerated form of
fluoride delivery in patients undergoing head and neck radiation therapy. If our hypotheses
are supported, additional studies will be undertaken with a larger sample size, and expanded
to include patients with head and neck cancers treated with chemotherapy or a combination of
cancer therapies.
All patients will undergo an initial dental visit, which will consist of medical consultation
with the patient's oncologist and standard dental and radiographic examinations. Patients
will return to have existing dental disease treated (eg. caries, gingival disease,
extractions). When treatment is complete, they will be invited to participate in the study.
The Screening Form will be used to confirm eligibility.
Study Visit #1 (Baseline) After obtaining consent, subjects will be randomly assigned to
receive fluoride therapy with either custom trays (Tray group) or by application with a
toothbrush (Brush group). Each subject will undergo a basic dental examination for
identification of new carious lesions. Visit #1 is the baseline, with a new caries score of
zero. Photographs will be taken of the subject's mouth and instructions for fluoride therapy
will be given.
Tray group: The subject will have custom vinyl vacuform fluoride trays made using an in-house
laboratory. They will be instructed to apply a "ribbon" of fluoride gel into each tray, and
then to wear each tray for 5 minutes, one tray at a time, after which the subject will
expectorate any remaining fluoride from the mouth.
Brush group: The subject will be instructed to apply a "ribbon" of fluoride gel onto the
toothbrush provided (Colgate Wave Sensitive) and to brush with the fluoride for 2 minutes at
bedtime.
Both groups: The subject may not rinse, eat, or drink for 30 minutes after the fluoride
treatment.
All subjects will be instructed to perform their fluoride therapy at bedtime and to document
the date and time of treatment on the Monthly Fluoride Log. All subjects will be provided
with 1.1% neutral sodium fluoride (PreviDent®) gel for the duration of the study. All
subjects will be instructed to return their monthly fluoride logs and any remaining fluoride
at each study visit.
Subjects will return for a follow-up examination at 3, 6, 9, and 12 months from the first
study visit. At each visit, the following procedures will be conducted:
- Update medical history
- Take photographs
- Conduct examination for caries
- Assess compliance with fluoride therapy
- Collect fluoride log for previous 3 months
- Dispense new fluoride log
- Collect and weigh returned fluoride tube
- Weigh and dispense new fluoride tube
- Dispense new toothbrush (Brush group only)
Subjects will be scheduled to immediately return to have any new carious lesions filled.
To evaluate compliance, subjects will be asked about their fluoride use according to standard
methods utilized by other experts in the field. High compliance is defined as daily use; low
compliance is defined as two to three times per week; not compliant is defined as less than
two times per week.
To evaluate caries incidence, the number of surfaces per tooth on which new caries appear
will be documented on the Caries Assessment Form. Caries will be scored using the
International Caries Classification and Management System criteria for clinical research.
Surfaces will be scored as either I (no obvious decay) or II (obvious decay). Bitewing
radiographs and periapical films (as needed) will be taken at 6 and 12 months after the
initial examination visit.
Descriptive statistics, including means (standard deviations) or counts (percentages), as
appropriate, will be used to summarize baseline demographic and clinical characteristics of
the two groups.
Inclusion Criteria:
- Age 18 years and older
- Diagnosis of cancer in the head and neck region
- Field of radiation must include the parotid gland(s) and/or submandibular gland region
- Able to speak English
- Able to provide consent
- Able to return for all study visits
Exclusion Criteria:
- Previous/current use of prescription strength fluoride
- Previous history of radiation to the head and neck region
- Presence of autoimmune disease(s)
- Currently pregnant
- Currently edentulous or will become edentulous prior to beginning radiation therapy
We found this trial at
1
site
Mesa, Arizona 85206
Phone: 480-248-8108
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