Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars

Dental Caries in Children Clinical Trial

Official title: Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars

Status Active, not recruiting

Clinical Trial Summary

This study aims to investigate the efficacy of silver diamine fluoride (SDF) and Papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children. by investigating the following outcomes:

1. Arrestment of caries lesion and the emergence of a new one

2. Time required for the treatment

3. Adverse events

4. Children's anxiety

Clinical Trial Description

The traditional approach to removing caries with dental burs is the most often used technique in the treatment of dental caries. However, this method is continuously associated with many disadvantages, such as patients finding drilling uncomfortable, the frequent need for local anesthetic, and detrimental heat effects on the pulp.

The purpose of this research was to evaluate three minimally invasive therapies via the assessment of:

1. Duration of treatment

2. (feeling of pain) and the need for anesthetic

3. Incidents with negative outcomes that have been officially documented

4. Filling material adhesiveness fellow up

The null hypothesis was that there was no difference among Silver Diamine Fluoride, Brix3000 Papain based Chemico-mechanical caries removal product, and ceramic burr in time, anxiety, and pain, reported side effect

Randomized control clinical trial will be allocated into 3 groups: S group (treatment with SDF), B group (treatment with Brix3000 Papain based gel), and C group as control (treatment by rotary handpiece Smart bur)

Setting:

Sample collection: the samples are to be collected at The College of Dentistry, Al-Mustansiriyah University - Iraq- Baghdad Subject The sample size will be 45 children aged 7-8 years with primary molars with occlusal active caries lesions. ;

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

• NCT number: NCT06412731
• Study type: Interventional
• Source: Al-Mustansiriyah University
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2024
• Completion date: June 1, 2024