Caries ArrestedPhase 3NCT05791669
Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution
A Phase 3 study testing Silver diamine fluoride and Sodium fluoride varnish in people with Caries Arrested, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Caries Arrested
- What is being tested?
- Silver diamine fluoride and Sodium fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2021to 8 Nov 2022
- Phase
- Phase 3
- 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5 to 9 years.
- Presence of at least 2 primary molars with interproximal caries.
- Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4).
Who cannot join
- 1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6).
- 3. Children or adolescents that refuse to participate in the study or present negative behaviours.
- 4. Teeth with premature hypermobility 5. Both physically and mentally disabled children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial
This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest.
Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3 - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine
- Conditions
- Caries Arrested
- Being tested
- Silver diamine fluoride, Sodium fluoride varnish
- Keywords
- Caries arrest ,interproximal caries, primary molars, SDF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver diamine fluorideDrug
Also called FAgamin SDF38%
Silver diamine fluoride is a topical medication composed of 25% silver, 5% fluoride, 8% ammonia, and 62% Deionized water, used to treat and prevent dental caries and relieve dentinal hypersensitivity.
Sodium fluoride varnishDrug
Also called VOCO profluorid varnish
It is a topical application with an active ingredient of 5% sodium fluoride(22,600ppm fluoride).it prolongs the contact time between the fluoride and tooth surface and promotes remineralization and inhibits demineralization.
| Study group | Role | What they receive |
|---|---|---|
| 38% silver diamine fluoride | Experimental | Not described Receives: Drug: Silver diamine fluoride |
| 5% sodium fluoride varnish | Active comparator | Not described Receives: Drug: Sodium fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries arrest
Assessment with bitewing radiographs based on ICCMS radiographic scoring system
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 posted30 Mar 2023
- Study start1 Aug 2021
- Primary completion2 Aug 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries ArrestedStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791669
- Sponsor's protocol ID
- PGIDS/BHRC/21/13
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05791669
- Acronym / sponsor ID
- PGIDS/BHRC/21/13
- Conditions
- Caries Arrested
- Keywords
- Caries arrest ,interproximal caries, primary molars, SDF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 30 Mar 2023 (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 study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest.
Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3 - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 38% silver diamine fluoride | Experimental | Drug: Silver diamine fluoride |
| 5% sodium fluoride varnish | Active comparator | Drug: Sodium fluoride varnish |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5 to 9 years.
- Presence of at least 2 primary molars with interproximal caries.
- Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4).
Key exclusion criteria (3 listed)
- 1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6).
- 3. Children or adolescents that refuse to participate in the study or present negative behaviours.
- 4. Teeth with premature hypermobility 5. Both physically and mentally disabled children
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 fluorideAlso: FAgamin SDF38%Silver diamine fluoride is a topical medication composed of 25% silver, 5% fluoride, 8% ammonia, and 62% Deionized water, used to treat and prevent dental caries and relieve dentinal hypersensitivity. | Drug | 38% silver diamine fluoride |
| Sodium fluoride varnishAlso: VOCO profluorid varnishIt is a topical application with an active ingredient of 5% sodium fluoride(22,600ppm fluoride).it prolongs the contact time between the fluoride and tooth surface and promotes remineralization and inhibits demineralization. | Drug | 5% sodium fluoride varnish |
Primary outcome
Caries arrest
Time frame: 12 months
Assessment with bitewing radiographs based on ICCMS radiographic scoring system
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 30 Mar 2023.
Related trials for Caries Arrested
Not yet recruitingPhase 3
Effectiveness of Single and Dual Silver Fluoride Application
Dentine Caries
Active, not recruiting
Comparing Two Brands of Silver Diamine Fluoride for Stopping Cavities in Children
Dental Caries
Recruiting
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
White Spot Lesions, Orthodontic Appliance Complication
Active, not recruitingPhase 2
Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel
Early Childhood Caries
Not yet recruiting
Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children
Early Childhood Caries (ECC), Active Dentin Caries in Primary Molars
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silver diamine fluoride and Sodium fluoride varnish in people with Caries Arrested, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 3 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 30 Mar 2023. 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 India. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Caries arrest (time frame: 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 30 Mar 2023.