Dental CariesEarly Phase 1NCT05403125
SDF Application in Oral Cancer Patients to Prevent Dental Caries
A Early Phase 1 study testing silver diamine fluoride, 38% and Sodium fluoride gel, 5000 PPM in people with Dental Caries, run by Texas A & M University Baylor College Of Dentistry at 1 site in United States.
Trial summary
The Texas A \& M College of Dentistry, with partner Texas Oncology-Baylor Charles A. Sammons Cancer-Center Radiation-Oncology, proposes to conduct a preliminary clinical study (NIH Stage 0) to pilot test a randomized clinical trial of the efficacy of professionally applied 38% silver diamine fluoride to prevent tooth… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries
- What is being tested?
- silver diamine fluoride, 38% and Sodium fluoride gel, 5000 PPM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2022to 18 Mar 2025
- 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
- Diagnosis of Head and Neck cancer
Who cannot join
- Prognosis less than 1 year
- Radiation field of treatment does not involve jaws
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Silver Diamine Fluoride: Novel Addition to the Prophylactic Bundle for Dental Management of Radiation-Induced Dental Caries in Oral and Pharyngeal Cancer Patients
The Texas A \& M College of Dentistry, with partner Texas Oncology-Baylor Charles A. Sammons Cancer-Center Radiation-Oncology, proposes to conduct a preliminary clinical study (NIH Stage 0) to pilot test a randomized clinical trial of the efficacy of professionally applied 38% silver diamine fluoride to prevent tooth decay in 60 patients who are being treated with radiation for life threatening head and neck cancer.
Read the detailed description
Head and neck cancer has increased in Texas over the last two decades. Radiation-induced tooth decay is a devastating yet potentially preventable side effect of the cancer treatment. Silver diamine fluoride, already the standard of care in children, is inexpensive, easy to apply, and safe. The objective of the research is to conduct a single site pilot RCT (NIH Stage 0) to determine feasibility and preliminarily assess the efficacy of 38% silver diamine fluoride and 5000 PPM fluoride gel for prevention of radiation-induced dental caries over 6 months. Eligible participants will be up to 60 head and neck cancer patients who are scheduled for radiotherapy. The proposed intervention will be applied within 1 m before and at 1- and 3-m post radiation. The primary outcome is dental caries surfaces at 6 months post-radiotherapy (DMFS).Secondary outcomes are The Gingival Index, Gingival Bleeding Index, MDASI-HN, and Oral Health Quality of Life score will be secondary outcomes.
- Conditions
- Dental Caries
- Being tested
- silver diamine fluoride, 38%, Sodium fluoride gel, 5000 PPM
- Keywords
- Oral and Pharyngeal Cancer, Xerostomia, Silver diamine fluoride, Sodium fluoride gel 5000 PPM
- Medical subject headings
- Dental Caries, Pharyngeal Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver diamine fluoride, 38%Device
Also called Advantage Silver Dental Arrest
Topical application to all surfaces of the teeth
Sodium fluoride gel, 5000 PPMDevice
Also called Elevate FluoriMax 5000R
Gel applied after application of silver diamine fluoride and dispensed for home use
| Study group | Role | What they receive |
|---|---|---|
| Package | Experimental | Topical application of 38% silver diamine fluoride plus 5000 PPM fluoride gel 1 mo before and 1 and 3 months after radiation treatment Receives: Device: silver diamine fluoride, 38%; Device: Sodium fluoride gel, 5000 PPM |
| Gel Alone | Active comparator | Placebo application of silver diamine fluoride plus 5000 PPM fluoride gel 1 mo before and 1 and 3 months after radiation treatment Receives: Device: Sodium fluoride gel, 5000 PPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Caries (DMFS)
Dental Caries Surfaces determined by intraoral inspection
Measured: 6 months
Secondary outcomes (4)
Gingival Index
Silness and Loe Gingival Index for assessment of gingival condition (0 to 3) determined clinically
Measured: 6 months
Bleeding Index
Bleeding at 6 sites of each tooth determined clinically
Measured: 6 months
Oral Health Quality of Life
Questionnaire
Measured: 6 months
MD Anderson Symptom Inventory-Head and Neck
Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start20 May 2022
- Primary completion11 Aug 2023
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial, Intention to Treat
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A & M University Baylor College Of Dentistry
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Amal Noureldin, Texas A & M University Baylor College Of Dentistry
- Investigators
- Amal Noureldin, DDS, Principal investigator, TAMU Baylor College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403125
- Sponsor's protocol ID
- SDF PCRP
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Noureldin AAK, Sones A, Mendoza L, Mancl L, Milgrom P. Effectiveness of silver diamine fluoride in preventing radiation-induced caries: A pilot study. J Am Dent Assoc. 2026 Jul 16:S0002-8177(26)00340-5. doi: 10.1016/j.adaj.2026.05.008. Online ahead of print.
PubMed 42461172
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silver Diamine Fluoride: Novel Addition to the Prophylactic Bundle for Dental Management of Radiation-Induced Dental Caries in Oral and Pharyngeal Cancer Patients
- ClinicalTrials.gov ID
- NCT05403125
- Acronym / sponsor ID
- SDF PCRP
- Conditions
- Dental Caries
- Keywords
- Oral and Pharyngeal Cancer, Xerostomia, Silver diamine fluoride, Sodium fluoride gel 5000 PPM
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Texas A & M University Baylor College Of DentistryUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 20 May 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 3 Jun 2022 (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.
The Texas A \& M College of Dentistry, with partner Texas Oncology-Baylor Charles A. Sammons Cancer-Center Radiation-Oncology, proposes to conduct a preliminary clinical study (NIH Stage 0) to pilot test a randomized clinical trial of the efficacy of professionally applied 38% silver diamine fluoride to prevent tooth decay in 60 patients who are being treated with radiation for life threatening head and neck cancer.
Detailed description
Head and neck cancer has increased in Texas over the last two decades. Radiation-induced tooth decay is a devastating yet potentially preventable side effect of the cancer treatment. Silver diamine fluoride, already the standard of care in children, is inexpensive, easy to apply, and safe. The objective of the research is to conduct a single site pilot RCT (NIH Stage 0) to determine feasibility and preliminarily assess the efficacy of 38% silver diamine fluoride and 5000 PPM fluoride gel for prevention of radiation-induced dental caries over 6 months. Eligible participants will be up to 60 head and neck cancer patients who are scheduled for radiotherapy. The proposed intervention will be applied within 1 m before and at 1- and 3-m post radiation. The primary outcome is dental caries surfaces at 6 months post-radiotherapy (DMFS).Secondary outcomes are The Gingival Index, Gingival Bleeding Index, MDASI-HN, and Oral Health Quality of Life score will be secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial, Intention to Treat
| Arm | Type | Receives |
|---|---|---|
| Package | Experimental | Device: silver diamine fluoride, 38%, Device: Sodium fluoride gel, 5000 PPMTopical application of 38% silver diamine fluoride plus 5000 PPM fluoride gel 1 mo before and 1 and 3 months after radiation treatment |
| Gel Alone | Active comparator | Device: Sodium fluoride gel, 5000 PPMPlacebo application of silver diamine fluoride plus 5000 PPM fluoride gel 1 mo before and 1 and 3 months after radiation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Head and Neck cancer
Key exclusion criteria (2 listed)
- Prognosis less than 1 year
- Radiation field of treatment does not involve jaws
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 |
|---|---|---|
| silver diamine fluoride, 38%Also: Advantage Silver Dental ArrestTopical application to all surfaces of the teeth | Device | Package |
| Sodium fluoride gel, 5000 PPMAlso: Elevate FluoriMax 5000RGel applied after application of silver diamine fluoride and dispensed for home use | Device | Gel Alone, Package |
Primary outcome
Dental Caries (DMFS)
Time frame: 6 months
Dental Caries Surfaces determined by intraoral inspection
4 secondary outcomes
Gingival Index
Time frame: 6 months
Bleeding Index
Time frame: 6 months
Oral Health Quality of Life
Time frame: 6 months
MD Anderson Symptom Inventory-Head and Neck
Time frame: 6 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 17 Sep 2025.
- Derived from this study: PubMed 42461172Noureldin AAK, Sones A, Mendoza L, Mancl L, Milgrom P. Effectiveness of silver diamine fluoride in preventing radiation-induced caries: A pilot study. J Am Dent Assoc. 2026 Jul 16:S0002-8177(26)00340-5. doi: 10.1016/j.adaj.2026.05.008. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Amal Noureldin, DDS principal investigator
TAMU Baylor College of Dentistry
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 silver diamine fluoride, 38% and Sodium fluoride gel, 5000 PPM in people with Dental Caries, run by Texas A & M University Baylor College Of Dentistry 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 1 inclusion and 2 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 17 Sep 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?
Dental Caries (DMFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05403125, which also lists 1 linked publication.
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 17 Sep 2025.