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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06412731
Enrollment
45
Registered
2024-05-14
Start date
2024-01-02
Completion date
2024-07-01
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries in Children

Keywords

CMCR, SDF, Ceramic bur

Brief 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.

Interventions

OTHERCera-bur

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

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

OTHERE-SDF

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

Sponsors

Al-Mustansiriyah University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 8 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse eventduring the first two weeksThe following adverse events will be investigated: Pain, sensitivity, tooth discoloration, burning in the mouth, allergy altered taste of food, irritation of the gums or mucosa
Filling fellow upafter 3 monthsThe evaluation was done using the community periodontal index (CPI)-probe (WHO-probe) and a dental mirror. The treated lesions were classified according to the evaluation scores which were modified from those used by Francis et al.: score 1 - the restoration intact, covering all pits and fissures; score 2 - the restoration partially lost, the tooth is sound (no active/soft caries); score 3 - the restoration partially lost, the tooth is carious(active/soft caries); score 4 - the restoration completely lost, the tooth is sound; and score 5 - the restoration completely lost, the tooth is carious. The tooth was considered sound if its surface felt hard and shiny

Secondary

MeasureTime frameDescription
anxiety levelimmediately after the procedureAnxiety level prescribed by the patient using a facial image scale to measure the children' anxiety. Each kid was instructed to indicate the facial expression that most accurately conveyed their current emotional state, which may be categorized as either (very happy; happy; neutral; unhappy; or very unhappy
TimeThis will take about from 5 to 30 minutesthe time required for the treatment in each group using a digital timer A digital timer which triggers as soon as the tooth brushing starts. During the first appointment starting from dental caries removal until sound dentin reached before Glass ionomer filling placement,

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026