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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06412731
• Other study ID #: MUPRU004
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Al-Mustansiriyah University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: June 1, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

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

Locations

Country	Name	City	State
Iraq	College of Dentistry, Mustansiriyah University	Baghdad	Al-karkh

Sponsors (1)

Lead Sponsor	Collaborator
Al-Mustansiriyah University

Country where clinical trial is conducted

Iraq, 

References & Publications (2)

Satyarup D, Mohanty S, Nagarajappa R, Mahapatra I, Dalai RP. Comparison of the effectiveness of 38% silver diamine fluoride and atraumatic restorative treatment for treating dental caries in a school setting: A randomized clinical trial. Dent Med Probl. 2 — View Citation

Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestme — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event	The 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	during the first two weeks
Primary	Filling fellow up	The 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	after 3 months
Secondary	anxiety level	Anxiety 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	immediately after the procedure
Secondary	Time	the 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,	This will take about from 5 to 30 minutes

External Links

•   Comparative Evaluation of 'Less Invasive Approach' of caries excavation and 'Only Arrest And No Excavation Approach' in dental caries management in primary molars- A Randomised Controlled Trial
•   Evaluation of the Efficacy of Caries Removal Using Papain Gel (Brix 3000) and Smart Preparation Bur(in vivo Comparative Study)