Dental CariesNCT06861725
CARIES ARREST USING SILVER DIAMINE FLUORIDE VERSUS FISSURE SEALANT IN OCCLUSAL DENTAL CARIOUS LESIONS
A study testing Silver Diamine Fluoride (SDF) and VOCO Fissurit in people with Dental Caries and Caries Arrested, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to evaluate if Silver Diamine Fluoride (SDF) is a more conservative and effective treatment in preventing the progression of mild occlusal caries compared to fissure sealant in patients aged 20-45 years with incipient molar caries. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Dental Caries, Caries Arrested, Silver Diamine Fluoride
- What is being tested?
- Silver Diamine Fluoride (SDF) and VOCO Fissurit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Jun 2026
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient consulting in the outpatient clinic.
- Patients with enamel caries in molars permanent teeth, according to ICDAS 1 and 2.
- Provide informed consent.
- Co-operative patients approving to participate in the trial.
- Patient age (20-45 years old).
Who cannot join
- Tooth mobility.
- Signs of pulpal infection.
- Severe medical conditions that would not allow management in the clinic.
- Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta.
- Known allergies or sensitivities to dental materials, including SDF and fissure sealant.
- Inability to return for recall visits.
- Patients with bad oral hygiene
- Refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CARIES ARREST USING SILVER DIAMINE FLUORIDE VERSUS FISSURE SEALANT IN OCCLUSAL DENTAL CARIOUS LESIONS: RANDOMIZED CONTROLLED TRIAL
The goal of this randomized clinical trial is to evaluate if Silver Diamine Fluoride (SDF) is a more conservative and effective treatment in preventing the progression of mild occlusal caries compared to fissure sealant in patients aged 20-45 years with incipient molar caries. The main question it aims to answer is:
Is SDF more effective in arresting caries progression than fissure sealant? Does SDF prevent the formation of new caries compared to fissure sealant? Researchers will compare SDF treatment to fissure sealant application to see if SDF results in better caries arrest and fewer new carious lesions.
Read more
Participants will:
Be randomly assigned to receive either SDF or fissure sealant. Have follow-up assessments at 1, 3, 6, and 12 months for caries progression, arrest, and new caries formation.
Undergo clinical evaluations using visual and tactile examinations to assess caries arrest and progression and using DIAGNOdent laser fluorescence system .
Read the detailed description
This randomized clinical trial aims to assess the efficacy of Silver Diamine Fluoride (SDF) compared to fissure sealant in arresting mild occlusal caries. The study is focused on patients aged 20 to 45 years who present with incipient caries in the molar teeth, classified under ICDAS 1 and 2. The study will be conducted at the Cairo University Dental Hospital, a tertiary healthcare and referral center.
The null hypothesis is there is no difference in the clinical performance between the application of silver diamine fluoride and fissure sealant in occlusal dental carious lesions.
Participants will be randomly assigned to one of two groups:
SDF Group: Silver Diamine Fluoride (38%) will be applied to the affected tooth surface. The treatment will be carried out by isolating the tooth, drying it thoroughly, applying SDF using a microbrush, and allowing it to remain on the surface for up to 3 minutes. Afterward, any excess will be removed, and the patient will be advised to avoid eating for 30 minutes.
Fissure Sealant Group: Fissure sealant (resin-based) will be applied to the affected occlusal surface. This procedure involves etching the surface with phosphoric acid, applying the sealant, and then curing it using a light-curing device. The sealant will form a protective barrier to prevent further demineralization.
The study will track two primary outcomes:
Caries progression, measured by the presence of visible cavitation or sensitivity during follow-up.
Caries arrest, determined through visual and tactile examination (e.g., probing to assess lesion hardness).
Secondary outcomes will include the formation of new caries, assessed using the DIAGNOdent laser fluorescence system.
Follow-up visits will occur at 1, 3, 6, and 12 months, where participants will be clinically assessed for pain, caries arrest, and new lesions. Clinical evaluations will include:
Visual and tactile examinations: Assessing the presence and activity level of carious lesions.
Caries progression: Identified by tactile detection with a dental explorer. Caries arrest: Lesions that have become hard and smooth will be considered arrested.
New caries: Monitored using the DIAGNOdent system for any signs of new decay. This trial will provide insight into whether SDF, a minimally invasive treatment, can offer a more effective and less expensive alternative to fissure sealants in arresting caries, especially in patients with early-stage occlusal caries.
- Being tested
- Silver Diamine Fluoride (SDF), VOCO Fissurit
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine Fluoride (SDF)Other
Silver Diamine Fluoride has been used extensively around the globe for decades. Advantage Arrest silver diamine fluoride 38% will change how you offer your patients the protection they deserve.
Advantage Arrest:
Provides immediate relief from dentinal hypersensitivity Kills pathogenic organisms Hardens softened dentin making it more acid and abrasion resistant Does not stain sound dentin or enamel Can provide important clinical feedback due to its potential to stain visible or hidden lesions Silver diamine fluoride 38% is indicated for the treatment of dentinal hypersensitivity.
VOCO FissuritOther
Transparent Light-cured pits and fissure sealant, with high stability and good adhesion to enamel
| Study group | Role | What they receive |
|---|---|---|
| VOCO Fissurit | Active comparator | Sealants are restorative dental materials applied to the pit-and-fissure surfaces of teeth. Upon application, the sealant material infiltrates the pits and fissures, subsequently polymerizing to form a hardened layer. This layer serves as a physical barrier, effectively preventing or restricting the penetration of bacteria and nutrients, thereby mitigating the risk of caries formation in these susceptible areas. Pit and fissure sealants: Evidence-based recommendations support the use of sealants for the prevention and management of pit and fissure caries. Sealants are effective and should be applied to the occlusal surfaces of first and second permanent molars. Additionally, non-operative cleaning of fissures with a toothbrush or bristle brush is recommended. Receives: Other: VOCO Fissurit |
| Silver Diamine Fluoride (SDF) | Experimental | Advantage Arrest Silver Diamine Fluoride 38%-SDF is an anti-microbial and remineralizing liquid clinically applied to control and arrest active dental caries and stop hypersensitivity. It is a safe, painless alternative to traditional cavity drilling procedures with the Power of Silver and Fluoride. Silver acts as an antimicrobial agent that simultaneously strengthens the dentin. Fluoride is the active ingredient that puts a stop to tooth decay by remineralising and helps prevent additional decay from appearing. It is also helpful to get relief from hypersensitivity.
The only common side effect is SDF causes black staining, but SDF/KI and NSF may reduce this staining effect. SDF can also stain surfaces that it comes into contact with when being applied, such as clothing or nearby tissues in the mouth. For best results, SDF should be reapplied every 3, 6, or 12 months, If the cavity still progresses. Receives: Other: Silver Diamine Fluoride (SDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria
detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria.
The fissure sealant and SDF will be evaluated at each recall visit for caries arrest through visual and tactile assessment, Arrested caries treated with silver diamine fluoride is clinically characterized by increased hardness and dark brown to black coloration . The clinical examination of fissure sealants involved evaluating the presence of visible cavitation. Although lesions can be seen through sealants.
Active caries will be identified when a blunt probe, applied with light pressure, can easily penetrate the lesion surface. Conversely, inactive (arrested) caries will be observed if the lesion surface is firm, smooth, and free from plaque. The number and percentage of arrested carious lesions will be recorded and assessed.
Measured: 1-3-6 and 12 month
Secondary outcomes (1)
evaluate carries arrest and new caries formation, measured by DIAGNOdent laser fluorescence system
The DIAGNOdent system provides fluorescence scores that range from 0 to 99. These scores indicate the level of caries activity or demineralization in the tooth structure.
-Score 0-13: Healthy Tooth Structure
-Score 14-20: Early Demineralization/Initial Lesion Mild demineralization is present, which may be reversible. These lesions might not be cavitated but show early signs of enamel breakdown..
-Score 21-40: Moderate Demineralization Clear signs of enamel breakdown, but the lesion is still confined to the enamel without progressing to the dentin.
-Score 41-60: Active Lesion Significant demineralization is occurring.
-Score 61-99: Cavitation and Severe Active Caries Indicates severe decay or active caries.
Measured: 1-3-6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abir Atmaz Alsibaee, Cairo University
- Investigators
- Omaima Safwat Hamza, Professor, Study director, Professor of Esthetic and Conservative Dentistry, Faculty of Dentistry, Cairo University in Egypt.Dina Mounir El-Kadi, Study director, Lecturer of Esthetic and Conservative Dentistry, Faculty of Dentistry, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861725
- Sponsor's protocol ID
- SDF VS FS in caries arrest
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARIES ARREST USING SILVER DIAMINE FLUORIDE VERSUS FISSURE SEALANT IN OCCLUSAL DENTAL CARIOUS LESIONS: RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT06861725
- Acronym / sponsor ID
- SDF VS FS in caries arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 6 Mar 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.
The goal of this randomized clinical trial is to evaluate if Silver Diamine Fluoride (SDF) is a more conservative and effective treatment in preventing the progression of mild occlusal caries compared to fissure sealant in patients aged 20-45 years with incipient molar caries. The main question it aims to answer is:
Is SDF more effective in arresting caries progression than fissure sealant? Does SDF prevent the formation of new caries compared to fissure sealant? Researchers will compare SDF treatment to fissure sealant application to see if SDF results in better caries arrest and fewer new carious lesions.
Participants will:
Be randomly assigned to receive either SDF or fissure sealant. Have follow-up assessments at 1, 3, 6, and 12 months for caries progression, arrest, and new caries formation.
Undergo clinical evaluations using visual and tactile examinations to assess caries arrest and progression and using DIAGNOdent laser fluorescence system .
Detailed description
This randomized clinical trial aims to assess the efficacy of Silver Diamine Fluoride (SDF) compared to fissure sealant in arresting mild occlusal caries. The study is focused on patients aged 20 to 45 years who present with incipient caries in the molar teeth, classified under ICDAS 1 and 2. The study will be conducted at the Cairo University Dental Hospital, a tertiary healthcare and referral center.
The null hypothesis is there is no difference in the clinical performance between the application of silver diamine fluoride and fissure sealant in occlusal dental carious lesions.
Participants will be randomly assigned to one of two groups:
SDF Group: Silver Diamine Fluoride (38%) will be applied to the affected tooth surface. The treatment will be carried out by isolating the tooth, drying it thoroughly, applying SDF using a microbrush, and allowing it to remain on the surface for up to 3 minutes. Afterward, any excess will be removed, and the patient will be advised to avoid eating for 30 minutes.
Fissure Sealant Group: Fissure sealant (resin-based) will be applied to the affected occlusal surface. This procedure involves etching the surface with phosphoric acid, applying the sealant, and then curing it using a light-curing device. The sealant will form a protective barrier to prevent further demineralization.
The study will track two primary outcomes:
Caries progression, measured by the presence of visible cavitation or sensitivity during follow-up.
Caries arrest, determined through visual and tactile examination (e.g., probing to assess lesion hardness).
Secondary outcomes will include the formation of new caries, assessed using the DIAGNOdent laser fluorescence system.
Follow-up visits will occur at 1, 3, 6, and 12 months, where participants will be clinically assessed for pain, caries arrest, and new lesions. Clinical evaluations will include:
Visual and tactile examinations: Assessing the presence and activity level of carious lesions.
Caries progression: Identified by tactile detection with a dental explorer. Caries arrest: Lesions that have become hard and smooth will be considered arrested.
New caries: Monitored using the DIAGNOdent system for any signs of new decay. This trial will provide insight into whether SDF, a minimally invasive treatment, can offer a more effective and less expensive alternative to fissure sealants in arresting caries, especially in patients with early-stage occlusal caries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VOCO Fissurit | Active comparator | Other: VOCO FissuritSealants are restorative dental materials applied to the pit-and-fissure surfaces of teeth. Upon application, the sealant material infiltrates the pits and fissures, subsequently polymerizing to form a hardened layer. This layer serves as a physical barrier, effectively preventing or restricting the penetration of bacteria and nutrients, thereby mitigating the risk of caries formation in these susceptible areas. Pit and fissure sealants: Evidence-based recommendations support the use of sealants for the prevention and management of pit and fissure caries. Sealants are effective and should be applied to the occlusal surfaces of first and second permanent molars. Additionally, non-operative cleaning of fissures with a toothbrush or bristle brush is recommended. |
| Silver Diamine Fluoride (SDF) | Experimental | Other: Silver Diamine Fluoride (SDF)Advantage Arrest Silver Diamine Fluoride 38%-SDF is an anti-microbial and remineralizing liquid clinically applied to control and arrest active dental caries and stop hypersensitivity. It is a safe, painless alternative to traditional cavity drilling procedures with the Power of Silver and Fluoride. Silver acts as an antimicrobial agent that simultaneously strengthens the dentin. Fluoride is the active ingredient that puts a stop to tooth decay by remineralising and helps prevent additional decay from appearing. It is also helpful to get relief from hypersensitivity. The only common side effect is SDF causes black staining, but SDF/KI and NSF may reduce this staining effect. SDF can also stain surfaces that it comes into contact with when being applied, such as clothing or nearby tissues in the mouth. For best results, SDF should be reapplied every 3, 6, or 12 months, If the cavity still progresses. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient consulting in the outpatient clinic.
- Patients with enamel caries in molars permanent teeth, according to ICDAS 1 and 2.
- Provide informed consent.
- Co-operative patients approving to participate in the trial.
- Patient age (20-45 years old).
Key exclusion criteria (8 listed)
- Tooth mobility.
- Signs of pulpal infection.
- Severe medical conditions that would not allow management in the clinic.
- Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta.
- Known allergies or sensitivities to dental materials, including SDF and fissure sealant.
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 (SDF)Silver Diamine Fluoride has been used extensively around the globe for decades. Advantage Arrest silver diamine fluoride 38% will change how you offer your patients the protection they deserve. Advantage Arrest: Provides immediate relief from dentinal hypersensitivity Kills pathogenic organisms Hardens softened dentin making it more acid and abrasion resistant Does not stain sound dentin or enamel Can provide important clinical feedback due to its potential to stain visible or hidden lesions Silver diamine fluoride 38% is indicated for the treatment of dentinal hypersensitivity. | Other | Silver Diamine Fluoride (SDF) |
| VOCO FissuritTransparent Light-cured pits and fissure sealant, with high stability and good adhesion to enamel | Other | VOCO Fissurit |
Primary outcome
detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria
Time frame: 1-3-6 and 12 month
detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria. The fissure sealant and SDF will be evaluated at each recall visit for caries arrest through visual and tactile assessment, Arrested caries treated with silver diamine fluoride is clinically characterized by increased hardness and dark brown to black coloration . The clinical examination of fissure sealants involved evaluating the presence of visible cavitation. Although lesions can be seen through sealants. Active caries will be identified when a blunt probe, applied with light pressure, can easily penetrate the lesion surface. Conversely, inactive (arrested) caries will be observed if the lesion surface is firm, smooth, and free from plaque. The number and percentage of arrested carious lesions will be recorded and assessed.
1 secondary outcome
evaluate carries arrest and new caries formation, measured by DIAGNOdent laser fluorescence system
Time frame: 1-3-6 and 12 month
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 20 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
Omaima Safwat Hamza, Professor study director
Professor of Esthetic and Conservative Dentistry, Faculty of Dentistry, Cairo University in Egypt.
Dina Mounir El-Kadi study director
Lecturer of Esthetic and Conservative Dentistry, Faculty of Dentistry, Cairo University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride (SDF) and VOCO Fissurit in people with Dental Caries and Caries Arrested, run by Cairo University at 1 site in Egypt.
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 8 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 20 Jul 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 Egypt. 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?
detect clinical progression done by the presence of visible cavitation and/or sensitivity during follow-up, measured by visual criteria (time frame: 1-3-6 and 12 month). 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 20 Jul 2026.