Dental DiseasesEarly Phase 1IPDPNCT07218068
Intensive Preventative Dental Program Pilot Study
A Early Phase 1 study testing Fluoride varnish, Regular Care and Medical Oncology Care Team in people with Dental Diseases, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Radiation therapy to treat cancer may cause a dry mouth from damage to salivary glands which may increase the risk of cavities on the teeth. The consistent use of prescription fluoride on teeth after radiation therapy for head and neck cancer may reduce the development of cavities and tooth loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Diseases
- What is being tested?
- Fluoride varnish, Regular Care and Medical Oncology Care Team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to 10 Jul 2024
- Phase
- Early 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
- Aged 18 years and older
- Willing and able to provide signed and dated consent form
- Presence of at least 4 natural erupted teeth remaining in the mouth after completion of pre-RT dental management
- Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;
- OR
- Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The participant must be expected to receive at least 4500 cGy to one of the following sites:
Show all 35Show fewer
- base of tongue
- buccal/labial mucosa
- epiglottis
- floor of mouth
- gingiva/alveolar ridge
- hard palate
- hypopharynx
- larynx
- lip
- mandible
- maxilla
- maxillary sinus
- nasal cavity
- nasopharynx
- neck
- oral cavity
- oral tongue
- oropharynx
- paranasal sinus/orbit
- parotid gland
- pharynx
- retromolar trigone
- soft palate
- sublingual gland
- submandibular gland
- tonsil;
- Willing to comply with all study procedures
- Willing to participate for the duration of the study
- RT follow-up planned for one of the selected AH Oncology Specialist Follow-up Sites.
Who cannot join
- Receiving palliative RT
- History of prior curative RT to the head and neck region to eradicate a malignancy.
- Incarcerated at the time of screening
- Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28203
About this study
Radiation therapy to treat cancer may cause a dry mouth from damage to salivary glands which may increase the risk of cavities on the teeth. The consistent use of prescription fluoride on teeth after radiation therapy for head and neck cancer may reduce the development of cavities and tooth loss. The purpose of this study is to find out if prescription fluoride varnish applied to the teeth every three months during the first year after radiation therapy changes the development of cavities or gum problems.
Read the detailed description
The overall objective of this clinical trial is to determine if oncology practices can reduce dental disease in head and neck cancer patients post radiation therapy. Participants will have fluoride varnish applied at planned oncology follow-up visits and medical oncology providers will be instructed on recognizing dental disease and referring head and neck cancer patients for dental care when needed.
- Conditions
- Dental Diseases
- Being tested
- Fluoride varnish, Regular Care, Medical Oncology Care Team
- Keywords
- Intensive Preventative Dental Program, dental caries, dental disease, prevention, head and neck cancer, Fluoride Varnishes, Osteoradionecrosis, dental infection
- Medical subject headings
- Stomatognathic Diseases, Dental Caries, Head and Neck Neoplasms, Osteoradionecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnishDrug
fluoride varnish placed on teeth by a trained healthcare provider at four visits three months apart
Regular CareOther
standard oncology assessment visit without Intensive Preventative Dental Program services
Medical Oncology Care TeamOther
Medical Oncology care team members participating in the Intensive Preventative Dental Program will be guided on recognizing dental disease and when it is appropriate to refer head and neck cancer patients for dental care.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Preventative Dental Program | Experimental | head and neck cancer patients receive fluoride varnish applied to teeth and follow-up dental screening during regularly scheduled oncology appointments. Receives: Drug: Fluoride varnish |
| Regular Care | Active comparator | control group consisting of head and neck cancer patients receiving regular care of no Intensive Preventative Dental Program. Receives: Other: Regular Care |
| Medical Oncology Team Providers | Experimental | Medical Oncology care team members (MD, DO, PA, NP, RN) who participate in Intensive Preventative Dental Program. Receives: Other: Medical Oncology Care Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Decayed, Missing and Filled Surfaces Score
Decayed, Missing and Filled Surfaces Score (DMFS) is calculated by a calibrated oral examiner as the combined number of of decayed, missing, and/or filled tooth surfaces, from the baseline dental visit DMFS score before starting radiotherapy to the final dental visit DMFS score 12 months following completion of radiation therapy.
Measured: from baseline to 12 months
Secondary outcomes (4)
Rate of Tooth Loss
Number of teeth lost per participant as determined by a calculated oral examiner from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.
Measured: from baseline to 12 months
Rate of Oral Hygiene Compliance
Number of participants who self-report daily toothbrushing and flossing from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.
Measured: from baseline to 12 months
Rate of Fluoride Compliance
Number of participants who self-reported use of prescription fluoride daily from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.
Measured: from baseline to 12 months
Rate of Routine/Preventative Dental Care
Number of participants who self-report visiting a dental office within the last six months from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.
Measured: from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start19 Oct 2021
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael T Brennan, DDS, MHS, Principal investigator, Atrium Health Wake Forest University Charlotte Medical CenterMatthew C. Ward, MD, Principal investigator, Atrium Health Levine Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218068
- Sponsor's protocol ID
- IRB00082720
- Other IDs
- 03-21-01A
- Acronym
- IPDP
- Status last verified
- Sep 2025
- First submitted
- 15 Oct 2025
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: As this is a pilot study which forms the basis of a larger clinical trial, individual deidentified participant data will be shared upon reasonable request to the primary investigators, along with a data dictionary outlining variables collected and data collection forms when appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Preventative Dental Program Pilot Study
- ClinicalTrials.gov ID
- NCT07218068
- Acronym / sponsor ID
- IPDP / IRB00082720
- Conditions
- Dental Diseases
- Keywords
- Intensive Preventative Dental Program, dental caries, dental disease, prevention, head and neck cancer, Fluoride Varnishes, Osteoradionecrosis, dental infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 20 Oct 2025 (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.
Radiation therapy to treat cancer may cause a dry mouth from damage to salivary glands which may increase the risk of cavities on the teeth. The consistent use of prescription fluoride on teeth after radiation therapy for head and neck cancer may reduce the development of cavities and tooth loss. The purpose of this study is to find out if prescription fluoride varnish applied to the teeth every three months during the first year after radiation therapy changes the development of cavities or gum problems.
Detailed description
The overall objective of this clinical trial is to determine if oncology practices can reduce dental disease in head and neck cancer patients post radiation therapy. Participants will have fluoride varnish applied at planned oncology follow-up visits and medical oncology providers will be instructed on recognizing dental disease and referring head and neck cancer patients for dental care when needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive Preventative Dental Program | Experimental | Drug: Fluoride varnishhead and neck cancer patients receive fluoride varnish applied to teeth and follow-up dental screening during regularly scheduled oncology appointments. |
| Regular Care | Active comparator | Other: Regular Carecontrol group consisting of head and neck cancer patients receiving regular care of no Intensive Preventative Dental Program. |
| Medical Oncology Team Providers | Experimental | Other: Medical Oncology Care TeamMedical Oncology care team members (MD, DO, PA, NP, RN) who participate in Intensive Preventative Dental Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Aged 18 years and older
- Willing and able to provide signed and dated consent form
- Presence of at least 4 natural erupted teeth remaining in the mouth after completion of pre-RT dental management
- Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;
- OR
Key exclusion criteria (4 listed)
- Receiving palliative RT
- History of prior curative RT to the head and neck region to eradicate a malignancy.
- Incarcerated at the time of screening
- Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study.
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 |
|---|---|---|
| Fluoride varnishfluoride varnish placed on teeth by a trained healthcare provider at four visits three months apart | Drug | Intensive Preventative Dental Program |
| Regular Carestandard oncology assessment visit without Intensive Preventative Dental Program services | Other | Regular Care |
| Medical Oncology Care TeamMedical Oncology care team members participating in the Intensive Preventative Dental Program will be guided on recognizing dental disease and when it is appropriate to refer head and neck cancer patients for dental care. | Other | Medical Oncology Team Providers |
Primary outcome
Change in Decayed, Missing and Filled Surfaces Score
Time frame: from baseline to 12 months
Decayed, Missing and Filled Surfaces Score (DMFS) is calculated by a calibrated oral examiner as the combined number of of decayed, missing, and/or filled tooth surfaces, from the baseline dental visit DMFS score before starting radiotherapy to the final dental visit DMFS score 12 months following completion of radiation therapy.
4 secondary outcomes
Rate of Tooth Loss
Time frame: from baseline to 12 months
Rate of Oral Hygiene Compliance
Time frame: from baseline to 12 months
Rate of Fluoride Compliance
Time frame: from baseline to 12 months
Rate of Routine/Preventative Dental Care
Time frame: from baseline to 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 3 Nov 2025.
- Individual participant dataSharing planned: Yes. As this is a pilot study which forms the basis of a larger clinical trial, individual deidentified participant data will be shared upon reasonable request to the primary investigators, along with a data dictionary outlining variables collected and data collection forms when appropriate.
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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.
Michael T Brennan, DDS, MHS principal investigator
Atrium Health Wake Forest University Charlotte Medical Center
Matthew C. Ward, MD principal investigator
Atrium Health Levine Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluoride varnish, Regular Care and Medical Oncology Care Team in people with Dental Diseases, run by Wake Forest University 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 35 inclusion and 4 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 3 Nov 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in Decayed, Missing and Filled Surfaces Score (time frame: from baseline to 12 months). 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 3 Nov 2025.