Evaluating and comparing two agents namely- Silver Diamine Fluoride (SDF) and Universal Bonding Agent (UBA) in reducing dental caries and dental hypersensitivity in decayed hypoplastic (weak) permanent molar teeth.

Comparative evaluation of Silver Diamine Fluoride (SDF) and Universal Bonding Agent (UBA) in reducing dental caries and dental hypersensitivity in cariously affected (ICDAS 1-4) Molar Incisor Hypoplastic (MIH) permanent molar teeth.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/043762

Enrollment

178

Registered

2022-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: K025- Dental caries on pit and fissure surface Health Condition 2: K026- Dental caries on smooth surface Health Condition 3: K004- Disturbances in tooth formation

Interventions

Intervention1: Universal bonding agent: Application of any commercially available Universal Bonding Agent on hypoplastic (MIH) decayed permanent teeth to arrest progression. Control Intervention1: Sil

Eligibility

Inclusion criteria

Inclusion criteria: children aged 6- 14 years of age MIH teeth with ICDAS- 2 score containing first digit 0, second digit scores of 1-4

Exclusion criteria

Exclusion criteria: 1. Teeth that have undergone any kind of restoration coded as per ICDAS restoration/ sealant code 1 to 9 (first digit) 2. history of spontaneous or elicited pain from caries. 3. pathological tooth mobility 4. signs of pulpal infection 5. children with severe medical conditions. 6. hereditary developmental defects like amelogenesis imperfecta or dentinogenesis imprefecta. 7. teeth with fluorotic hypoplasia 8. known allergies or sensitivities to dental materials used in the study (like SDF/ UBA) 9. definitely uncooperative children (Frankl definitely negative)

Design outcomes

Primary

Measure	Time frame
Assessing for caries arrest: Positive outcomes - Dark, hard, and black lesions with no pain or infection Negative outcomes -Progression of the lesion, a yellow, brown, soft lesion with or without pain or infection. Assessing dental hypersensitivity: (Schiff Cold Air Sensitivity Scale (SCASS) and / or VAS scores will used to assess the presence of hypersensitivity). Positive outcomes – Improvement in SCASS and / or VAS scores Negative outcomes- No improvement or worsening of SCASS and / or VAS scores Timepoint: Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months	—

Measure

Time frame

Assessing for caries arrest: Positive outcomes - Dark, hard, and black lesions with no pain or infection Negative outcomes -Progression of the lesion, a yellow, brown, soft lesion with or without pain or infection. Assessing dental hypersensitivity: (Schiff Cold Air Sensitivity Scale (SCASS) and / or VAS scores will used to assess the presence of hypersensitivity). Positive outcomes – Improvement in SCASS and / or VAS scores Negative outcomes- No improvement or worsening of SCASS and / or VAS scores Timepoint: Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months

—

Secondary

Measure	Time frame
aesthetic outcome: Likert-scale questionnaire shall be used in children to know outcome.Timepoint: Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months	—

Countries

India

Contacts

Public ContactCHERANJEEVI JAYAM

All India Institute Of Medical Sciences Mangalagiri

cheranjeevij@gmail.com8894337313

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026