Caries RootsEarly Phase 1NCT04255251
Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
A Early Phase 1 study testing Silver Diammine Fluoride and Fluoride Varnishes in people with Caries Roots and Flouride Varnish, run by University of New England at 1 site in United States.
Trial summary
Dental caries is a multifactorial, progressive disease which is the major causes of dental pain, infection and tooth loss. Dental caries can substantially compromise the quality of life in older adults 1 2. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Roots, Flouride Varnish, Caries; Dentin
- What is being tested?
- Silver Diammine Fluoride and Fluoride Varnishes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2021to 3 Jan 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-85 years old with crown/bridges
- Open crown margins
- Decay present around crown margins
- Pt is not intention to go with the conventiontial restorative treatment to replace the crown for any reason
- Subjects who can do the follow up for at least one year
Who cannot join
- Teeth with periapical lesion
- Teeth which have pain to percussion
- Subjects who have silver or fluoride allergy
- Subjects who have gingivitis
- Subjects who have stomatitis
- Subjects who have tooth mobility
- Subjects who have furcation involvement
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of New England
Portland, Maine, 04101
SHAISTA RASHID, D.D.S, 207-221-4861, srashid2@une.edu
About this study
Dental caries is a multifactorial, progressive disease which is the major causes of dental pain, infection and tooth loss. Dental caries can substantially compromise the quality of life in older adults 1 2. As the number of older adults in the US increases, the dental professionals have become increasingly concerned with the dental need of elderly and preventive regimes to reduce the incidence of caries3 .
Prevention becomes an area of paramount importance. Many studies have advocated nonsurgical intervention for shallow dentin caries lesion.The most effective method for prevention to date is considered to be fluoride. In the United states fluoride has been incorporated in many ways like water fluoridation, fluoride mouth wash, dentifrices and professionally applied fluoride varnishes . The American Dental Association (ADA) recommended the use of fluoride for patients of all ages who are at risk of developing dental caries7 . With the high success of fluoride, another treatment method using Silver Diamine Fluoride (SDF) is gaining popularity in the United States. SDF has been used in many countries like Japan, Australia, China, and Cuba for treatment of caries . Successful treatment data from other countries is promising, and promoting the use of SDF in the United States. SDF is available in the United States as 38% aqueous solution and approved as a desensitizing agent. American Dental Association published an evidence-based clinical practice guideline on nonrestorative treatments for caries teeth and recommended use of SDF on a carious cavitated lesion on permanent teeth9 . Clinical studies have shown the effectiveness of SDF in arresting root caries in older adults.
Read the detailed description
Potential subjects will be identified through regular appointments. Screening will be performed on subjects to determine their eligibility based on inclusion and exclusion criteria. Subjects will sign an informed consent before enrollment in the study. Patient will be receiving one of the two fluoride treatments, Silver Diamine Fluoride or Sodium fluoride, to arrest caries around crown margins. Clinical and radiographic exam will be performed on all the participants.
Clinical exam will include the following
- DIAGOdent:
- Tectile exam:
The procedures of every clinical appointments will be as following:
First appointment:
Visit will include
- Health history
- Caries risk assessment
- Clinical exam (DIAGNOdent, tactile) (described above)
- Radiograph (described above)
- Subject will sigh consent form
- Treatment group will receive SDF
- Control group will receive Fluoride varnish
Second visit (6 month from the first appointment ):
Visit will include
- Health history retake
- Caries risk assessment retake
- New Clinical exam (DIAGNOdent, tactile)
- New Radiograph
- Subject will receive his or her treatment according to their allocation
Third visit (12 month from the first appointment ):
Visit will include
- Health history retake
- Caries risk assessment retake
- New Clinical exam (DIAGNOdent, tactile)
- New Radiograph
- Subject will receive his or her treatment according to their allocation
Third visit (12 month from the first appointment ):
Visit will include
- Health history retake
- Caries risk assessment retake
- New Clinical exam (DIAGNOdent, tactile)
- New Radiograph
- Subject will receive his or her treatment according to their allocation
- Conditions
- Caries Roots, Flouride Varnish, Caries; Dentin, Caries Arrested
- Being tested
- Silver Diammine Fluoride, Fluoride Varnishes
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diammine FluorideDrug
Subjects will receive SDF around their crown margins every 6 months for next 3 years.
Fluoride VarnishesDrug
Subjects will receive SDF around their crown margins every 6 months for next 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Subjects in this group will receive Silver Diamine Fluoride around their crown margins every six month for the next 3 years. Receives: Drug: Silver Diammine Fluoride |
| Fluoride varnish group | Active comparator | Subjects in this group will receive fluoride varnish around their crown margins every six month for the next 3 years. Receives: Drug: Fluoride Varnishes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tactile exam to evaluate extend of caries around tooth margin
WHO ball end probe will be used to detect cavities around the restoration margins.
Code 0: Sound tooth surface with restoration Code 1: First visual change in enamel Code 2: Distinct visual change in enamel/ dentin adjacent to restoration Code 3: Carious defect of more than 0.5 mm Code 4: Marginal caries in enamel/dentin/cementum adjacent to restoration with dark shadow Code 5: Distinct cavity adjacent to restoration Code 6: Extensive distinct cavity with visible dentine
Measured: Every 6 month for next 3 years
Secondary outcomes (1)
DIAGOdent: laser fluorescence to aid in the detection of caries
As the incident laser light is dispersed into the site, carious tooth structure will exhibit fluorescence, proportionate to the degree of caries, resulting in elevated scale readings on the display. Healthy tooth structure exhibits little or no fluorescence and will result in very low scale readings on the display. Over 90% accurate in detecting lesions not detectable with an explorer or bitewing X-rays. The remote display for DIAGNOdent pen uses infra-red signals, and the values are shown simultaneously on the DIAGNOdent pen and on the remote display
Measured: Every 6 month for next 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start26 Jun 2021
- Primary completion3 Jan 2023 (estimated)
- Study completion3 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caries RootsStudies 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
- Participants will be assigned randomly into treatment and control group using a predetermined randomization protocol.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaista Rashid, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255251
- Sponsor's protocol ID
- Universityof New Engalnd
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Giusti L, Steinborn C, Steinborn M. Use of silver diamine fluoride for the maintenance of dental prostheses in a high caries-risk patient: A medical management approach. J Prosthet Dent. 2018 May;119(5):713-716. doi: 10.1016/j.prosdent.2017.06.007. Epub 2017 Sep 6.
PubMed 28888414Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019 Jul 12;19(1):145. doi: 10.1186/s12903-019-0830-5.
PubMed 31299955
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults
- ClinicalTrials.gov ID
- NCT04255251
- Acronym / sponsor ID
- Universityof New Engalnd
- Conditions
- Caries Roots, Flouride Varnish, Caries; Dentin, Caries Arrested
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of New EnglandUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 3 Jan 2023 (estimated)
- Study completion
- 3 Jan 2024 (estimated)
- First posted
- 5 Feb 2020 (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.
Dental caries is a multifactorial, progressive disease which is the major causes of dental pain, infection and tooth loss. Dental caries can substantially compromise the quality of life in older adults 1 2. As the number of older adults in the US increases, the dental professionals have become increasingly concerned with the dental need of elderly and preventive regimes to reduce the incidence of caries3 .
Prevention becomes an area of paramount importance. Many studies have advocated nonsurgical intervention for shallow dentin caries lesion.The most effective method for prevention to date is considered to be fluoride. In the United states fluoride has been incorporated in many ways like water fluoridation, fluoride mouth wash, dentifrices and professionally applied fluoride varnishes . The American Dental Association (ADA) recommended the use of fluoride for patients of all ages who are at risk of developing dental caries7 . With the high success of fluoride, another treatment method using Silver Diamine Fluoride (SDF) is gaining popularity in the United States. SDF has been used in many countries like Japan, Australia, China, and Cuba for treatment of caries . Successful treatment data from other countries is promising, and promoting the use of SDF in the United States. SDF is available in the United States as 38% aqueous solution and approved as a desensitizing agent. American Dental Association published an evidence-based clinical practice guideline on nonrestorative treatments for caries teeth and recommended use of SDF on a carious cavitated lesion on permanent teeth9 . Clinical studies have shown the effectiveness of SDF in arresting root caries in older adults.
Detailed description
Potential subjects will be identified through regular appointments. Screening will be performed on subjects to determine their eligibility based on inclusion and exclusion criteria. Subjects will sign an informed consent before enrollment in the study. Patient will be receiving one of the two fluoride treatments, Silver Diamine Fluoride or Sodium fluoride, to arrest caries around crown margins. Clinical and radiographic exam will be performed on all the participants.
Clinical exam will include the following
- DIAGOdent:
- Tectile exam:
The procedures of every clinical appointments will be as following:
First appointment:
Visit will include
- Health history
- Caries risk assessment
- Clinical exam (DIAGNOdent, tactile) (described above)
- Radiograph (described above)
- Subject will sigh consent form
- Treatment group will receive SDF
- Control group will receive Fluoride varnish
Second visit (6 month from the first appointment ):
Visit will include
- Health history retake
- Caries risk assessment retake
- New Clinical exam (DIAGNOdent, tactile)
- New Radiograph
- Subject will receive his or her treatment according to their allocation
Third visit (12 month from the first appointment ):
Visit will include
- Health history retake
- Caries risk assessment retake
- New Clinical exam (DIAGNOdent, tactile)
- New Radiograph
- Subject will receive his or her treatment according to their allocation
Third visit (12 month from the first appointment ):
Visit will include
- Health history retake
- Caries risk assessment retake
- New Clinical exam (DIAGNOdent, tactile)
- New Radiograph
- Subject will receive his or her treatment according to their allocation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be assigned randomly into treatment and control group using a predetermined randomization protocol.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Silver Diammine FluorideSubjects in this group will receive Silver Diamine Fluoride around their crown margins every six month for the next 3 years. |
| Fluoride varnish group | Active comparator | Drug: Fluoride VarnishesSubjects in this group will receive fluoride varnish around their crown margins every six month for the next 3 years. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65-85 years old with crown/bridges
- Open crown margins
- Decay present around crown margins
- Pt is not intention to go with the conventiontial restorative treatment to replace the crown for any reason
- Subjects who can do the follow up for at least one year
Key exclusion criteria (7 listed)
- Teeth with periapical lesion
- Teeth which have pain to percussion
- Subjects who have silver or fluoride allergy
- Subjects who have gingivitis
- Subjects who have stomatitis
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 Diammine FluorideSubjects will receive SDF around their crown margins every 6 months for next 3 years. | Drug | Intervention group |
| Fluoride VarnishesSubjects will receive SDF around their crown margins every 6 months for next 3 years. | Drug | Fluoride varnish group |
Primary outcome
Tactile exam to evaluate extend of caries around tooth margin
Time frame: Every 6 month for next 3 years
WHO ball end probe will be used to detect cavities around the restoration margins. Code 0: Sound tooth surface with restoration Code 1: First visual change in enamel Code 2: Distinct visual change in enamel/ dentin adjacent to restoration Code 3: Carious defect of more than 0.5 mm Code 4: Marginal caries in enamel/dentin/cementum adjacent to restoration with dark shadow Code 5: Distinct cavity adjacent to restoration Code 6: Extensive distinct cavity with visible dentine
1 secondary outcome
DIAGOdent: laser fluorescence to aid in the detection of caries
Time frame: Every 6 month for next 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 28888414Giusti L, Steinborn C, Steinborn M. Use of silver diamine fluoride for the maintenance of dental prostheses in a high caries-risk patient: A medical management approach. J Prosthet Dent. 2018 May;119(5):713-716. doi: 10.1016/j.prosdent.2017.06.007. Epub 2017 Sep 6.
- Results publication: PubMed 31299955Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019 Jul 12;19(1):145. doi: 10.1186/s12903-019-0830-5.
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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.
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 Diammine Fluoride and Fluoride Varnishes in people with Caries Roots and Flouride Varnish, run by University of New England 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Oct 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaista Rashid, B.D.S, M.S. (2072214861, srashid2@une.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile exam to evaluate extend of caries around tooth margin (time frame: Every 6 month for next 3 years). 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 NCT04255251, which also lists 2 linked publications.
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 5 Oct 2021.