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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2024-07-01

Brief Summary

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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

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Detailed Description

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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

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ceramic bur (Cerabur) C

Cera bur (Ceramic Bur) Komet, Lemgo, Germany

Group Type ACTIVE_COMPARATOR

Cera-bur

Intervention Type OTHER

Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material

Silver Diamine Fluoride (e-SDF) S

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

Group Type ACTIVE_COMPARATOR

E-SDF

Intervention Type OTHER

Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling

CMCR gel (Brix3000) B

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

Group Type ACTIVE_COMPARATOR

Brix3000

Intervention Type OTHER

Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material

Interventions

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Cera-bur

Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material

Intervention Type OTHER

Brix3000

Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material

Intervention Type OTHER

E-SDF

Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling

Intervention Type OTHER

Other Intervention Names

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Ceramic bur Papain-based CMCR 38% Silver Diamine fluoride

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes