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

Al-Mustansiriyah University

Status: Completed

Conditions: Dental Caries in Children

Treatments: Other: Brix3000; Other: Cera-bur; Other: E-SDF

Study type: Interventional

Funder types: Other

Identifiers

NCT06412731

MUPRU004

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 7 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Each child should have primary molars with open carious lesions, either on the occlusal surface or Proximal one with the absence of a neighboring tooth.
• These lesions should affect the dentin but not expose the pulp.
• The depth of the cavities should measure between 40-99 using a DIAGNOdent caries detection instrument for standardization

Exclusion criteria

• Children were excluded if parents were unwilling to be assigned to any of the approaches
• Children that had any abnormal medical condition or silver or papain allergy
• Chose molars with clinical or radiographic signals of pulp involvement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Ceramic bur (Cerabur) C

Active Comparator group

Description:

Cera bur (Ceramic Bur) Komet, Lemgo, Germany

Treatment:

Other: Cera-bur

Silver Diamine Fluoride (e-SDF) S

Active Comparator group

Description:

e-SDF (SDF 38%) E-kids, India

Treatment:

Other: E-SDF

CMCR gel (Brix3000) B

Active Comparator group

Description:

Brix3000 (Papain based gel) S.R.L., Argentina

Treatment:

Other: Brix3000