Early Childhood Caries (ECC)Phase 2SDFNCT07893756
Evaluation of Silver Diamine Fluoride, Sodium Fluoride With Casein Phosphopeptide-Amorphous Calcium Phosphate(MI Varnish) and Dycal to Arrest Caries When Used in Indirect Pulp Capping Procedures in Children
A Phase 2 study testing Silver Diamine Fluoride (SDF, 38%) gel, Sodium Fluoride with CPP-ACP (MI varnish) and Calcium Hydroxide (CH) in people with Early Childhood Caries (ECC) and Color Stability of Restoration, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
Early childhood caries is a serious public health issue often neglected and goes untreated having detrimental effects on the child and their family. Hence, multiple teeth are affected with dental caries approaching close to pulp. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Early Childhood Caries (ECC), Color Stability of Restoration, Caries Arrested
- What is being tested?
- Silver Diamine Fluoride (SDF, 38%) gel, Sodium Fluoride with CPP-ACP (MI varnish) and Calcium Hydroxide (CH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 May 2024to 16 Jun 2026
- Phase
- Phase 2
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 3 to 9 years
- Presenting with at least one untreated cavitated active Class I carious lesion in a primary mandibular second molar were considered for inclusion. Diagnosis of carious lesions was based on Nyvad's clinical criteria (Level 3), indicating dentinal involvement without pulp exposure or symptoms of irreversible pulpitis, which was confirmed with an intra-oral periapical radiograph.
- Only systemically healthy children, as confirmed by medical history, were included.
Who cannot join
- Children with irreversible pulpitis, spontaneous pain, periapical abscess, sinus tract, fistula, or tooth mobility were excluded from the study.
- Those with special healthcare needs or systemic illnesses Children of whose parents declined consent, were also excluded.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Dentistry, Jazan University
Jizan, Jazan Region, 45142
About this study
Early childhood caries is a serious public health issue often neglected and goes untreated having detrimental effects on the child and their family. Hence, multiple teeth are affected with dental caries approaching close to pulp. Unfortunately, there is insufficient clinical studies evidence to demonstrate the indirect pulp capping efficacy of the available remineralizing dental materials and the color stability of restorations placed over them over a period of time.
Read the detailed description
Children from 3 to 6 years age having Early Childhood Caries, and children from 6-9 years will undergo indirect pulp treatment in teeth showing signs of irreversible pulpitis.
This randomized controlled clinical trial will evaluate and compare the efficacy of SDF gel+ KI , NaF + CPP- ACP (MI varnish) and dycal as indirect pulp capping procedures in children. In addition, data was collected to assess the color stability of the aesthetic restorations following the application of these pulp capping materials.
- Conditions
- Early Childhood Caries (ECC), Color Stability of Restoration, Caries Arrested, Caries,Dental
- Being tested
- Silver Diamine Fluoride (SDF, 38%) gel, Sodium Fluoride with CPP-ACP (MI varnish), Calcium Hydroxide (CH)
- Keywords
- SILVER DIAMINE FLUORIDE, Indirect pulp capping
- 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, 38%) gelDrug
Silver diamine fluoride is applied in gel form
Sodium Fluoride with CPP-ACP (MI varnish)Drug
Sodium fluoride with RECALDENT
Calcium Hydroxide (CH)Drug
Dycal is the gold standard material used for pulp capping, hence this will be used in active comparator arm
| Study group | Role | What they receive |
|---|---|---|
| cavitated caries lesions involving enamel and dentin but not pulp with experimental drugs | Experimental | Reversible pulpitis Receives: Drug: Silver Diamine Fluoride (SDF, 38%) gel; Drug: Sodium Fluoride with CPP-ACP (MI varnish) |
| cavitated caries lesions involving enamel and dentin but not pulp with Calcium hydroxide | Active comparator | Reversible pulpitis Receives: Drug: Calcium Hydroxide (CH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of pulpitis to determine success of indirect pulp capping procedure
All teeth after intervention will be clinically assessed for success of pulp capping procedure.
Clinical assessment of pulpitis was done based on following criteria
- Tenderness to percussion or palpation
- Tooth mobility
- Signs of soft tissue inflammation, sinus tract, or fistula formation
- Presence or absence of postoperative pain If the tooth is asymptomatic with no signs of pulpitis , then the tooth is recorded as treatment positive.
If any tooth shows any above signs of pulpitis it will be evaluated as treatment negative.
Measured: The outcomes will be clinically assessed from the date of intervention up to 3 months for success of pulp capping procedure.
Assessment of color stability of restorations placed after indirect pulp capping procedure
Color evaluation of the carious site was performed using both an intraoral spectrophotometer (VITA Easyshade® Advance) and a smartphone-based digital system (Chromatcher) using CIELAB( all perceptible colors using three values) scores . The change in visual perception was calculated with the Delta E (▲E) values for both Spectrophotometer and Smartphone- based digital system.
Measured: The outcome will be assessed before intervention, immediately after placing the restoration up to 3 months using both Spectrophotometer and Smartphone- based digital system.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start6 May 2024
- Primary completion2 Jun 2025
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood Caries (ECC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This three-arm phase 2 clinical trial will be conducted to evaluate the effectiveness of silver diamine fluoride (SDF) gel and MI varnish when used as indirect pulp capping agent and the color stability of restorations placed above them.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Renuga Lakshmi, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893756
- Sponsor's protocol ID
- CODJU 22121
- Other IDs
- CODJU 22121
- Acronym
- SDF
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the IPD because the study can be continued for long term in future
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Silver Diamine Fluoride, Sodium Fluoride With Casein Phosphopeptide-Amorphous Calcium Phosphate(MI Varnish) and Dycal to Arrest Caries When Used in Indirect Pulp Capping Procedures in Children
- ClinicalTrials.gov ID
- NCT07893756
- Acronym / sponsor ID
- SDF / CODJU 22121
- Conditions
- Early Childhood Caries (ECC), Color Stability of Restoration, Caries Arrested, Caries,Dental
- Keywords
- SILVER DIAMINE FLUORIDE, Indirect pulp capping
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 6 May 2024 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 26 Oct 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.
Early childhood caries is a serious public health issue often neglected and goes untreated having detrimental effects on the child and their family. Hence, multiple teeth are affected with dental caries approaching close to pulp. Unfortunately, there is insufficient clinical studies evidence to demonstrate the indirect pulp capping efficacy of the available remineralizing dental materials and the color stability of restorations placed over them over a period of time.
Detailed description
Children from 3 to 6 years age having Early Childhood Caries, and children from 6-9 years will undergo indirect pulp treatment in teeth showing signs of irreversible pulpitis.
This randomized controlled clinical trial will evaluate and compare the efficacy of SDF gel+ KI , NaF + CPP- ACP (MI varnish) and dycal as indirect pulp capping procedures in children. In addition, data was collected to assess the color stability of the aesthetic restorations following the application of these pulp capping materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This three-arm phase 2 clinical trial will be conducted to evaluate the effectiveness of silver diamine fluoride (SDF) gel and MI varnish when used as indirect pulp capping agent and the color stability of restorations placed above them.
| Arm | Type | Receives |
|---|---|---|
| cavitated caries lesions involving enamel and dentin but not pulp with experimental drugs | Experimental | Drug: Silver Diamine Fluoride (SDF, 38%) gel, Drug: Sodium Fluoride with CPP-ACP (MI varnish)Reversible pulpitis |
| cavitated caries lesions involving enamel and dentin but not pulp with Calcium hydroxide | Active comparator | Drug: Calcium Hydroxide (CH)Reversible pulpitis |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 3 to 9 years
- Presenting with at least one untreated cavitated active Class I carious lesion in a primary mandibular second molar were considered for inclusion. Diagnosis of carious lesions was based on Nyvad's clinical criteria (Level 3), indicating dentinal involvement without pulp exposure or symptoms of irreversible pulpitis, which was confirmed with an intra-oral periapical radiograph.
- Only systemically healthy children, as confirmed by medical history, were included.
Key exclusion criteria (2 listed)
- Children with irreversible pulpitis, spontaneous pain, periapical abscess, sinus tract, fistula, or tooth mobility were excluded from the study.
- Those with special healthcare needs or systemic illnesses Children of whose parents declined consent, were also excluded.
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, 38%) gelSilver diamine fluoride is applied in gel form | Drug | cavitated caries lesions involving enamel and dentin but not pulp with experimental drugs |
| Sodium Fluoride with CPP-ACP (MI varnish)Sodium fluoride with RECALDENT | Drug | cavitated caries lesions involving enamel and dentin but not pulp with experimental drugs |
| Calcium Hydroxide (CH)Dycal is the gold standard material used for pulp capping, hence this will be used in active comparator arm | Drug | cavitated caries lesions involving enamel and dentin but not pulp with Calcium hydroxide |
Primary outcome
Clinical assessment of pulpitis to determine success of indirect pulp capping procedure
Time frame: The outcomes will be clinically assessed from the date of intervention up to 3 months for success of pulp capping procedure.
All teeth after intervention will be clinically assessed for success of pulp capping procedure. Clinical assessment of pulpitis was done based on following criteria * Tenderness to percussion or palpation * Tooth mobility * Signs of soft tissue inflammation, sinus tract, or fistula formation * Presence or absence of postoperative pain If the tooth is asymptomatic with no signs of pulpitis , then the tooth is recorded as treatment positive. If any tooth shows any above signs of pulpitis it will be evaluated as treatment negative.
Assessment of color stability of restorations placed after indirect pulp capping procedure
Time frame: The outcome will be assessed before intervention, immediately after placing the restoration up to 3 months using both Spectrophotometer and Smartphone- based digital system.
Color evaluation of the carious site was performed using both an intraoral spectrophotometer (VITA Easyshade® Advance) and a smartphone-based digital system (Chromatcher) using CIELAB( all perceptible colors using three values) scores . The change in visual perception was calculated with the Delta E (▲E) values for both Spectrophotometer and Smartphone- based digital 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 26 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to share the IPD because the study can be continued for long term in future
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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.
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 2 study testing Silver Diamine Fluoride (SDF, 38%) gel, Sodium Fluoride with CPP-ACP (MI varnish) and Calcium Hydroxide (CH) in people with Early Childhood Caries (ECC) and Color Stability of Restoration, run by University of Jazan at 1 site in Saudi Arabia.
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 2 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 26 Oct 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 Saudi Arabia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinical assessment of pulpitis to determine success of indirect pulp capping procedure (time frame: The outcomes will be clinically assessed from the date of intervention up to 3 months for success of pulp capping procedure.). 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?
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 26 Oct 2026.