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.

Phase 2

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

• Registration Number: CTRI/2022/07/043762
• Lead Sponsor: ALL INDIA INSTITUTE OF MEDICAL SCIENCES MANGALAGIRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 220

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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