Dental CariesNCT03267914
Impact of Compliance With Fluoride Use on Caries Incidence After Cancer Therapy
A study testing Tray and Brush in people with Dental Caries and Oral Cavity Cancer, run by A.T. Still University of Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dental Caries, Oral Cavity Cancer, Oral Complications of Chemotherapy and Head/Neck Radiation
- What is being tested?
- Tray and Brush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to 22 Nov 2021
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
A.T. Still University, Arizona School of Dentistry & Oral Health
Mesa, Arizona, 85206
About this study
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.
Read the detailed description
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.
- Conditions
- Dental Caries, Oral Cavity Cancer, Oral Complications of Chemotherapy and Head/Neck Radiation
- Being tested
- Tray, Brush
- Medical subject headings
- Dental Caries, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrayOther
Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day.
BrushOther
Patients will brush with the fluoride for 2 minutes each day.
| Study group | Role | What they receive |
|---|---|---|
| Tray group | Experimental | Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day. Receives: Other: Tray |
| Brush group | Active comparator | Patients will brush with the fluoride for 2 minutes each day. Receives: Other: Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoride use compliance
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). 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.
Measured: 3 months
Fluoride use compliance
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). 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.
Measured: 6 months
Fluoride use compliance
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). 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.
Measured: 9 months
Fluoride use compliance
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). 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.
Measured: 12 months
Secondary outcomes (4)
Dental caries incidence assessed at 4 time points
To evaluate caries incidence clinically, 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).
Measured: 3 months
Dental caries incidence assessed clinically at 4 time points
To evaluate caries incidence clinically, 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).
Measured: 6 months
Dental caries incidence assessed at 4 time points
To evaluate caries incidence clinically, 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).
Measured: 9 months
Dental caries incidence assessed at 4 time points
To evaluate caries incidence clinically, 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start29 Aug 2017
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to receive fluoride therapy with either custom trays (Tray group) or by application with a toothbrush (Brush group).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seena Patel, A.T. Still University of Health Sciences
- Investigators
- Seena Patel, DMD, MPH, Principal investigator, A.T. Still University, Arizona School of Dentistry & Oral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267914
- Sponsor's protocol ID
- 2017-005
- Status last verified
- Nov 2021
- First submitted
- 14 Aug 2017
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Compliance With Fluoride Use on Caries Incidence After Cancer Therapy
- ClinicalTrials.gov ID
- NCT03267914
- Acronym / sponsor ID
- 2017-005
- Conditions
- Dental Caries, Oral Cavity Cancer, Oral Complications of Chemotherapy and Head/Neck Radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 31 Aug 2017 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to receive fluoride therapy with either custom trays (Tray group) or by application with a toothbrush (Brush group).
| Arm | Type | Receives |
|---|---|---|
| Tray group | Experimental | Other: TrayControl intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day. |
| Brush group | Active comparator | Other: BrushPatients will brush with the fluoride for 2 minutes each day. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| TrayControl intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day. | Other | Tray group |
| BrushPatients will brush with the fluoride for 2 minutes each day. | Other | Brush group |
Primary outcome
Fluoride use compliance
Time frame: 3 months
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). 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.
Fluoride use compliance
Time frame: 6 months
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). 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.
Fluoride use compliance
Time frame: 9 months
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). 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.
Fluoride use compliance
Time frame: 12 months
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). 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.
4 secondary outcomes
Dental caries incidence assessed at 4 time points
Time frame: 3 months
Dental caries incidence assessed clinically at 4 time points
Time frame: 6 months
Dental caries incidence assessed at 4 time points
Time frame: 9 months
Dental caries incidence assessed at 4 time points
Time frame: 12 months
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 24 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Seena Patel, DMD, MPH principal investigator
A.T. Still University, Arizona School of Dentistry & Oral Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tray and Brush in people with Dental Caries and Oral Cavity Cancer, run by A.T. Still University of Health Sciences 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 6 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 24 Nov 2021. 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.
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?
Fluoride use compliance (time frame: 3 months). The study lists 4 primary outcomes in all. 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 24 Nov 2021.