NCT06412731

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Al-Mustansiriyah University · Academic / Other
• Sex: All
• Age: 7 Years – 8 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
OTHER	Cera-bur	Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material
OTHER	Brix3000	Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material
OTHER	E-SDF	Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling

Timeline

• Start date: 2024-01-02
• Primary completion: 2024-05-23
• Completion: 2024-07-01
• First posted: 2024-05-14
• Last updated: 2025-05-08

Locations

1 site across 1 country: Iraq