Comparison of two methods to arrest(stop) caries in milk teeth of children

Phase 3

Not yet recruiting

• Conditions: Dental caries on smooth surface,

• Registration Number: CTRI/2025/05/086881
• Lead Sponsor: Abhishna P

Brief Summary

This is a non inferiority randomized controlled trial using a parallel study design comparing nano silver modified atraumatic restorative technique with silver diamine modified atraumatic restorative technique in terms of clinical success ,degree of discoloration and parental satisfaction at follow up visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-20
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• 1.Apparently healthy children in the age group 4-9 years.
• 2.Asymptomatic dentinal cavitated lesions accessible to hand instrumentation in at least one primary molar.
• 3.Children with Frankl behavior rating scale positive or definitely positive.
• 4.Children whose parents have consented to take part in the study and whose parents accept to report for the scheduled follow up.

Exclusion Criteria

• 1.Teeth with a history of pain in the tooth of interest, signs of pulpal and periapical pathology, such as having an abscess, fistula or sinus.
• 2.Children with developmental defects/hypoplasia in relation to the selected tooth.
• 3.Physiologic tooth mobility due to root resorption.
• 4.Children with known allergy to silver.
• 5.Children with designated molars having more than two surfaces involved with caries.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the success of atraumatic restorative technique on asymptomatic cavitated carious lesions in primary molars following pretreatment with either nano silver fluoride or silver diamine fluoride solution.	6 and 12 months

Secondary Outcome Measures

Name	Time	Method
To evaluate & compare the degree of discolouration caused by the two atruamatic restorative techniques.	6 & 12 months
To compare & measure the parental satisfaction with the children’s dental appearance after treatment with two restorative techniques	6 & 12 months

Trial Locations

Locations (1)

Centre for dental education and research; 🇮🇳 Delhi, DELHI, India

Centre for dental education and research

🇮🇳Delhi, DELHI, India

Dr Abhishna P

Principal investigator

9895077423

abhishnaabhi2@gmail.com