Carious LesionNCT07125937
Silver Diamine Flouride in Arresting Enamel Caries
A study testing 38% Silver Diamine Fluoride in people with Carious Lesion, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This interventional study aims to evaluate the effectiveness of 38% Silver Diamine Fluoride (SDF) in arresting enamel caries in adults aged 18-50 years. Dental caries is a biofilm-mediated, multifactorial disease that can cause progressive tooth damage. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Carious Lesion
- What is being tested?
- 38% Silver Diamine Fluoride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 sitePakistan
- Study dates
- 7 May 2024to 7 May 2025
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group of subjects between 18 - 50 years
- Carious lesions with ICDAS score 1, 2 and 3 in molars and premolars
Who cannot join
- PDL widening with periapical radiolucency around molars and premolars
- Premolars and Molars with any white lesions other than caries
- Third molars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ROLE OF SILVER DIAMINE FLUORIDE (SDF) IN ARRESTING ENAMEL CARIES IN ADULTS REPORTING TO DENTAL COLLEGE HITEC-IMS TAXILA
This interventional study aims to evaluate the effectiveness of 38% Silver Diamine Fluoride (SDF) in arresting enamel caries in adults aged 18-50 years. Dental caries is a biofilm-mediated, multifactorial disease that can cause progressive tooth damage. Conventional treatments are invasive and costly, whereas SDF offers a non-invasive, low-cost alternative. A total of 250 patients meeting the inclusion criteria will be treated with SDF following the UCSF protocol. Lesions will be evaluated clinically using ICDAS and radiographically using ICCMS at 3 weeks and 3 months post-intervention. The primary outcome is the proportion of enamel caries lesions arrested after treatment. Data will be analyzed using the chi-square test.
- Conditions
- Carious Lesion
- Being tested
- 38% Silver Diamine Fluoride
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
38% Silver Diamine FluorideDrug
A topical ammonia solution containing silver and fluoride ions applied directly to enamel caries lesions. Application will follow the UCSF protocol: lesions will be cleaned, isolated, and treated with SDF for 2 minutes using a microbrush applicator.
| Study group | Role | What they receive |
|---|---|---|
| 38% Silver Diamine Fluoride Application | Experimental | Participants will receive a single application of 38% Silver Diamine Fluoride (Advantage Arrest™, Elevate Oral Care LLC) on enamel caries lesions (ICDAS scores 1-3) in molars and premolars, following the UCSF protocol. Lesions will be evaluated clinically (ICDAS) and radiographically (ICCMS) at 3 weeks and 3 months post-treatment to assess caries arrest. Receives: Drug: 38% Silver Diamine Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enamel caries lesions arrested after SDF application
Lesions will be clinically evaluated using the International Caries Detection and Assessment System (ICDAS) and radiographically using the International Caries Classification and Management System (ICCMS). Arrest is defined as no progression in ICDAS score and no radiographic progression
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start7 May 2024
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious LesionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kinza Iftikhar, HITEC-Institute of Medical Sciences
- Investigators
- Dr Kinza Iftikhar, BDS, Principal investigator, HITEC-Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125937
- Sponsor's protocol ID
- Dr Kinza
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLE OF SILVER DIAMINE FLUORIDE (SDF) IN ARRESTING ENAMEL CARIES IN ADULTS REPORTING TO DENTAL COLLEGE HITEC-IMS TAXILA
- ClinicalTrials.gov ID
- NCT07125937
- Acronym / sponsor ID
- Dr Kinza
- Conditions
- Carious Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- HITEC-Institute of Medical SciencesUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 15 Aug 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.
This interventional study aims to evaluate the effectiveness of 38% Silver Diamine Fluoride (SDF) in arresting enamel caries in adults aged 18-50 years. Dental caries is a biofilm-mediated, multifactorial disease that can cause progressive tooth damage. Conventional treatments are invasive and costly, whereas SDF offers a non-invasive, low-cost alternative. A total of 250 patients meeting the inclusion criteria will be treated with SDF following the UCSF protocol. Lesions will be evaluated clinically using ICDAS and radiographically using ICCMS at 3 weeks and 3 months post-intervention. The primary outcome is the proportion of enamel caries lesions arrested after treatment. Data will be analyzed using the chi-square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 38% Silver Diamine Fluoride Application | Experimental | Drug: 38% Silver Diamine FluorideParticipants will receive a single application of 38% Silver Diamine Fluoride (Advantage Arrest™, Elevate Oral Care LLC) on enamel caries lesions (ICDAS scores 1-3) in molars and premolars, following the UCSF protocol. Lesions will be evaluated clinically (ICDAS) and radiographically (ICCMS) at 3 weeks and 3 months post-treatment to assess caries arrest. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age group of subjects between 18 - 50 years
- Carious lesions with ICDAS score 1, 2 and 3 in molars and premolars
Key exclusion criteria (3 listed)
- PDL widening with periapical radiolucency around molars and premolars
- Premolars and Molars with any white lesions other than caries
- Third molars
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 |
|---|---|---|
| 38% Silver Diamine FluorideA topical ammonia solution containing silver and fluoride ions applied directly to enamel caries lesions. Application will follow the UCSF protocol: lesions will be cleaned, isolated, and treated with SDF for 2 minutes using a microbrush applicator. | Drug | 38% Silver Diamine Fluoride Application |
Primary outcome
Proportion of enamel caries lesions arrested after SDF application
Time frame: 3 months post-intervention
Lesions will be clinically evaluated using the International Caries Detection and Assessment System (ICDAS) and radiographically using the International Caries Classification and Management System (ICCMS). Arrest is defined as no progression in ICDAS score and no radiographic progression
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 15 Aug 2025.
- Related InfoLink provided by the sponsor.
- 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.
Dr Kinza Iftikhar, BDS principal investigator
HITEC-Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 38% Silver Diamine Fluoride in people with Carious Lesion, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
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 2 inclusion and 3 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 15 Aug 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 Pakistan. 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?
Proportion of enamel caries lesions arrested after SDF application (time frame: 3 months post-intervention). 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 15 Aug 2025.