Dentine CariesPhase 3NCT07658690
Effectiveness of Single and Dual Silver Fluoride Application
A Phase 3 study testing 38% Silver Fluoride (Riva Star Aqua) in people with Dentine Caries, run by University of Malaya at 1 site in Malaysia.
Trial summary
This is a community-based, parallel-group, double-blinded randomised controlled trial aimed at evaluating the effectiveness of single and dual applications of 38% Silver Fluoride (SF) in arresting dentinal caries among Malaysian preschool children aged 4 to 6 years. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Dentine Caries
- What is being tested?
- 38% Silver Fluoride (Riva Star Aqua)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2026to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-6 years enrolled in selected preschools.
- Presence of at least one active dentinal caries lesion.
- Parental or guardian consent obtained.
- Asymptomatic cavitated dentine carious lesions in primary teeth.
- Parents/caregivers who understand the Malay language.
Who cannot join
- Clinical signs or symptoms of irreversible pulpitis or dental abscess/fistula.
- Systemic illness or medical contraindications for SF use.
- Developmental abnormalities of tooth structure, including amelogenesis imperfecta or dentinogenesis imperfecta.
- History of allergy or sensitivity to dental materials, including silver or fluoride contained in silver fluoride (SF).
- Children who have received professionally applied fluoride within the past three months at the time of recruitment.
- Arrested caries lesion.
Show all 9Show fewer
- Children presenting with oral ulceration or mucositis.
- Uncooperative behaviour precluding oral examination.
- Children with pre-shedding tooth mobility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Tengku Nurfarhana Nadirah Tengku Hamzah(Dr), BDS, MClinDent contact
Malaysia1 site
Preschools in Perak
Tapah, Perak, 35000
Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate, 016-7786161, dr.mohamadnoor@moh.gov.my
Nurfazlina Rosman (Dr), DDS, MCOH
About this study
Official title: The Effectiveness of Single and Dual Silver Fluoride (SF) Applications on Dentine Caries Among Malaysian Preschool Children: A Randomised Controlled Trial
This is a community-based, parallel-group, double-blinded randomised controlled trial aimed at evaluating the effectiveness of single and dual applications of 38% Silver Fluoride (SF) in arresting dentinal caries among Malaysian preschool children aged 4 to 6 years.
The main questions this study aims to answer are:
Read more
- Does dual application of 38% Silver Fluoride differ from single application in arresting dentinal caries lesions after 6 months? ii) How does SF application influence oral health-related quality of life (OHRQoL) among preschool children, as measured by the Malay-ECOHIS questionnaire? iii) Is there a correlation between caries arrest and changes in Oral Health-Related Quality of Life (OHRQoL) measured using the Malay-ECOHIS questionnaire?
Researchers will compare children receiving a single application of 38% Silver Fluoride with those receiving dual applications to determine whether more frequent application improves caries arrest outcomes.
Participants will:
- Undergo oral examination for assessment of dentinal caries using ICDAS criteria. ii) Receive 38% Silver Fluoride application at baseline, with the dual-application group receiving an additional application at 3 months. iii) Attend follow-up assessments at 3 and 6 months to evaluate caries arrest status. iv) Have parents or guardians complete the Malay-ECOHIS questionnaire to assess changes in OHRQoL.
- Conditions
- Dentine Caries
- Being tested
- 38% Silver Fluoride (Riva Star Aqua), Normal Saline (Placebo)
- Keywords
- Silver Fluoride, Caries Arrest, Randomised Controlled Trial, Preschool Children, Silver Diamine Fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
38% Silver Fluoride (Riva Star Aqua)Drug
Topical application of 38% silver fluoride will be apply onto dentinal caries lesions using a micro-brush at baseline and 3 months follow up. One drop (0.05 mL) treats up to five surfaces. Maximum dose per visit does not exceed 260 µL.
Normal Saline (Placebo)Other
Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months
| Study group | Role | What they receive |
|---|---|---|
| Single Application of Silver Fluoride | Placebo comparator | Single applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and followed by placebo (normal saline) at 3 months Receives: Drug: 38% Silver Fluoride (Riva Star Aqua); Other: Normal Saline (Placebo) |
| Dual Application of Silver Fluoride | Experimental | Two applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and 3 months. Receives: Drug: 38% Silver Fluoride (Riva Star Aqua) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries arrest at tooth surface level
Lesions are considered arrested if they are hard upon probing using WHO probe and have turned black in colour. Each tooth may contribute up to five surfaces, with analysis conducted at the lesion level.
Measured: 6 months
Proportion of arrested lesions
Caries arrest will be assessed at the tooth surface level. The outcome is defined as the proportion of lesions classified as arrested out of the total treated lesions in each group. Comparisons will be made between single and dual application groups. Analyses will be conducted at both surface (lesion) level and participant level, accounting for clustering of lesions within individuals.
Measured: 6 months
Secondary outcomes (2)
Change in OHRQoL (Malay-ECOHIS score)
Change in total Malay-ECOHIS score from baseline to 6 months will be assessed. The Malay-ECOHIS is a validated parent-reported questionnaire measuring the impact of oral health on children and their families. Scores range from 0 to 52, with higher scores indicating worse oral health-related quality of life. A reduction in score reflects improvement in OHRQoL.
Measured: Baseline to 6 months
To determine correlation between caries arrest rate and change in total Malay-ECOHIS score
This outcome will assess the correlation between caries arrest rate at 6 months and change in total Malay-ECOHIS score from baseline to 6 months.
Caries arrest rate (%) will be assessed by clinical examination and calculated as the number of arrested treated dentinal caries lesions divided by the total number of treated dentinal caries lesions per participant, multiplied by 100. The unit of measure is percentage (%) of arrested treated dentinal caries lesions.
Change in total Malay-ECOHIS score will be assessed using the Malay-ECOHIS questionnaire. The change score will be calculated as the total score at 6 months minus the baseline total score. The unit of measure is change in total Malay-ECOHIS score. Pearson correlation will be used if normality assumptions are met; otherwise, Spearman rank correlation will be used.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
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 Dentine 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel-group, double-blinded randomised controlled trial. Participants will be allocated in a 1:1 ratio to either single or dual application of 38% silver fluoride and will remain in their assigned group throughout the study period. Outcomes will be compared between groups at follow-up. Randomisation will be performed at the individual child level.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurfazlina binti Rosman, University of Malaya
- Investigators
- Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658690
- Sponsor's protocol ID
- DF CO2505/0018 (P)
- Status last verified
- Jul 2026
- First submitted
- 12 May 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations
Publications
Yan IG, Zheng FM, Gao SS, Duangthip D, Lo ECM, Chu CH. A Review of the Protocol of SDF Therapy for Arresting Caries. Int Dent J. 2022 Oct;72(5):579-588. doi: 10.1016/j.identj.2022.06.006. Epub 2022 Jul 14.
PubMed 35843730
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Single and Dual Silver Fluoride (SF) Applications on Dentine Caries Among Malaysian Preschool Children: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07658690
- Acronym / sponsor ID
- DF CO2505/0018 (P)
- Conditions
- Dentine Caries
- Keywords
- Silver Fluoride, Caries Arrest, Randomised Controlled Trial, Preschool Children, Silver Diamine Fluoride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 22 Jun 2026 (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 is a community-based, parallel-group, double-blinded randomised controlled trial aimed at evaluating the effectiveness of single and dual applications of 38% Silver Fluoride (SF) in arresting dentinal caries among Malaysian preschool children aged 4 to 6 years.
The main questions this study aims to answer are:
- Does dual application of 38% Silver Fluoride differ from single application in arresting dentinal caries lesions after 6 months? ii) How does SF application influence oral health-related quality of life (OHRQoL) among preschool children, as measured by the Malay-ECOHIS questionnaire? iii) Is there a correlation between caries arrest and changes in Oral Health-Related Quality of Life (OHRQoL) measured using the Malay-ECOHIS questionnaire?
Researchers will compare children receiving a single application of 38% Silver Fluoride with those receiving dual applications to determine whether more frequent application improves caries arrest outcomes.
Participants will:
- Undergo oral examination for assessment of dentinal caries using ICDAS criteria. ii) Receive 38% Silver Fluoride application at baseline, with the dual-application group receiving an additional application at 3 months. iii) Attend follow-up assessments at 3 and 6 months to evaluate caries arrest status. iv) Have parents or guardians complete the Malay-ECOHIS questionnaire to assess changes in OHRQoL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a parallel-group, double-blinded randomised controlled trial. Participants will be allocated in a 1:1 ratio to either single or dual application of 38% silver fluoride and will remain in their assigned group throughout the study period. Outcomes will be compared between groups at follow-up. Randomisation will be performed at the individual child level.
| Arm | Type | Receives |
|---|---|---|
| Single Application of Silver Fluoride | Placebo comparator | Drug: 38% Silver Fluoride (Riva Star Aqua), Other: Normal Saline (Placebo)Single applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and followed by placebo (normal saline) at 3 months |
| Dual Application of Silver Fluoride | Experimental | Drug: 38% Silver Fluoride (Riva Star Aqua)Two applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and 3 months. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 4-6 years enrolled in selected preschools.
- Presence of at least one active dentinal caries lesion.
- Parental or guardian consent obtained.
- Asymptomatic cavitated dentine carious lesions in primary teeth.
- Parents/caregivers who understand the Malay language.
Key exclusion criteria (9 listed)
- Clinical signs or symptoms of irreversible pulpitis or dental abscess/fistula.
- Systemic illness or medical contraindications for SF use.
- Developmental abnormalities of tooth structure, including amelogenesis imperfecta or dentinogenesis imperfecta.
- History of allergy or sensitivity to dental materials, including silver or fluoride contained in silver fluoride (SF).
- Children who have received professionally applied fluoride within the past three months at the time of recruitment.
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 Fluoride (Riva Star Aqua)Topical application of 38% silver fluoride will be apply onto dentinal caries lesions using a micro-brush at baseline and 3 months follow up. One drop (0.05 mL) treats up to five surfaces. Maximum dose per visit does not exceed 260 µL. | Drug | Dual Application of Silver Fluoride, Single Application of Silver Fluoride |
| Normal Saline (Placebo)Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months | Other | Single Application of Silver Fluoride |
Primary outcome
Caries arrest at tooth surface level
Time frame: 6 months
Lesions are considered arrested if they are hard upon probing using WHO probe and have turned black in colour. Each tooth may contribute up to five surfaces, with analysis conducted at the lesion level.
Proportion of arrested lesions
Time frame: 6 months
Caries arrest will be assessed at the tooth surface level. The outcome is defined as the proportion of lesions classified as arrested out of the total treated lesions in each group. Comparisons will be made between single and dual application groups. Analyses will be conducted at both surface (lesion) level and participant level, accounting for clustering of lesions within individuals.
2 secondary outcomes
Change in OHRQoL (Malay-ECOHIS score)
Time frame: Baseline to 6 months
To determine correlation between caries arrest rate and change in total Malay-ECOHIS score
Time frame: 0-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 35843730Yan IG, Zheng FM, Gao SS, Duangthip D, Lo ECM, Chu CH. A Review of the Protocol of SDF Therapy for Arresting Caries. Int Dent J. 2022 Oct;72(5):579-588. doi: 10.1016/j.identj.2022.06.006. Epub 2022 Jul 14.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations
Related trials for Dentine Caries
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Active, not recruiting
Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
Class I Dental Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations
Dental Caries, Composite Resins
Not yet recruitingPhase 2
A Clinical Study of KH001 for Pulp Preservation and Safety in Deep Dentin Caries
Dental Caries
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.
Dr. Tengku Nurfarhana Nadirah Tengku Hamzah(Dr), BDS, MClinDent contact
Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD principal investigator
University of Malaya
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 38% Silver Fluoride (Riva Star Aqua) in people with Dentine Caries, run by University of Malaya at 1 site in Malaysia.
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 9 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: opening soon, as of the sponsor's last update on 31 Aug 2026. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD (+6010-2716747, azlida@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries arrest at tooth surface level (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT07658690, 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 31 Aug 2026.