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Comparative evaluation of efficacy of SDF modified with Potassium iodide and Glutathione on tooth discoloration after biannual application among children aged 6 to 9 years A Randomized controlled trial

Comparative evaluation of efficacy of SDF modified with Potassium iodide and Glutathione on tooth discoloration after biannual application among children aged 6 to 9 years A Randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101470
Enrollment
70
Registered
2026-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Silver diamine fluoride and glutathione: SDF as a preventive procedure have also been effective in reducing anxiety in both parents and children as it is noninvasive procedure thereby i

Sponsors

Uzma Parveen Qureshi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. Patient aged 6 to 9 years ii. Incipient caries involving maxillary canine & 1st decidious molar iii. Earliest lesion that can be identified as the initial stages of demineralization (Mount & Hume classification 1997). iv. Minimal surface cavitation with involvement of dentine just beyond treatment by remineralization alone (Mount & Hume classification 1997)

Exclusion criteria

Exclusion criteria: i. Patient with systemic diseases ii. Non-restorable or pulpally involved teeth either clinically or radiographically. iii. Primary teeth with developmental disturbance. iv. Patient who refuses to come for follow up.

Design outcomes

Primary

MeasureTime frame
Caries arrest effectiveness of SDF modified with KI versus SDF modified with GSH Measured by clinical arrest of carious lesions at 12 months Indicators include Hardness of the lesion on probing Absence of progression to pulpal involvement Need (or no need) for further operative treatmentTimepoint: outcome will be assessed at baseline 3 months 6 months 12 months

Secondary

MeasureTime frame
Tooth Discoloration Change in color of the treated carious lesion after Initial application Reapplication at 6 months Final evaluation at 12 months Comparison of discoloration severity between Group A (SDF + KI) Group B (SDF + GSH) Tooth Survival Survival rate of treated primary teeth over 12 months Defined as Teeth remaining functional No clinical or radiographic signs of pulpal failure No requirement for extraction or endodontic intervention Analyzed using survival analysisTimepoint: baseline 3 months 6 & 12 months

Countries

India

Contacts

Public ContactUZMA PARVEEN QURESHI

Dr DY Patil dental college hospital Pimpri Pune

ladusingh.rajpurohit@dpu.edu.in7057810131

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026