A Phase 2 interventional study of Silver Diamine Fluoride (SDF, 38%) gel and Sodium Fluoride with CPP-ACP (MI varnish) in Early Childhood Caries (ECC), Color Stability of Restoration and Caries Arrested, sponsored by University of Jazan. Completed at 1 site in Saudi Arabia. Open to participants aged 3 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University of Jazan · Phase 2, Interventional, and Treatment
Among 26 studies testing silver diamine fluoride in Dental Caries — 4 open to participants now, 4 under way, none of them phase 3. silver diamine fluoride · Dental Caries.
Among the 26 studies testing silver diamine fluoride in Dental Caries, this one is the 9th largest by enrollment, is one of 3 that started in 2024, is one of 6 in phase 2, and was the 25th registered.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →4 of the 26 studies testing silver diamine fluoride in Dental Caries are open now, in 3 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.
This study: 3 Years to 9 Years · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2024.
Median enrollment 60 across the 26 interventional studies. Of the 16 that completed or were terminated, 5 (31%) have results posted.
4 of 26 have an industry lead sponsor. The 10 most frequent:
University of Jazan is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
University of Jazan has 3 studies filed under Dental Caries — fewer than ten, so there is no comparison to draw.
2 of the studies testing silver diamine fluoride in Dental Caries that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07194629Université de MontréalPilot and Feasibility Study of Impact of SDF 38% Application on Oral Health of Elderly With Autonomy Loss | 2026-11-15 |
| NCT07903155Cairo UniversityClinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars | 2027-11 |
Among the 26 studies testing silver diamine fluoride in Dental Caries, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Reversible pulpitis
Drug: Silver Diamine Fluoride (SDF, 38%) gel · Drug: Sodium Fluoride with CPP-ACP (MI varnish)
Reversible pulpitis
Drug: Calcium Hydroxide (CH)
Silver diamine fluoride is applied in gel form
Drug pages: Sodium Fluoride · Casein phosphopeptide-amorphous calcium phosphate nanocomplex
Sodium fluoride with RECALDENT
Dycal is the gold standard material used for pulp capping, hence this will be used in active comparator arm
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.
Time frame: 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.
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.
Plan to share: No — There is no plan to share the IPD because the study can be continued for long term in future
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Silver diamine fluoride · Sodium Fluoride · Casein phosphopeptide-amorphous calcium phosphate nanocomplex
University of Jazan