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

NCT06412731 | Completed

• 1 other identifier: MUPRU004
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 1.Arrestment of caries lesion and the emergence of a new one
2. 2.Time required for the treatment
3. 3.Adverse events
4. 4.Children's anxiety

Conditions

Dental Caries in Children

Keywords

CMCR; SDF; Ceramic bur

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• anxiety level

  immediately after the procedure

• Time

  This will take about from 5 to 30 minutes

Study Arms (3)

Ceramic bur (Cerabur) C

ACTIVE COMPARATOR

Cera bur (Ceramic Bur) Komet, Lemgo, Germany

Other: Cera-bur

Silver Diamine Fluoride (e-SDF) S

ACTIVE COMPARATOR

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

Other: E-SDF

CMCR gel (Brix3000) B

ACTIVE COMPARATOR

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

Other: Brix3000

Interventions

Cera-bur OTHER

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

Also known as: Ceramic bur

Ceramic bur (Cerabur) C

Brix3000 OTHER

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

Also known as: Papain-based CMCR

CMCR gel (Brix3000) B

E-SDF OTHER

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

Also known as: 38% Silver Diamine fluoride

Silver Diamine Fluoride (e-SDF) S

Eligibility Criteria

• Age: 7 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

College of Dentistry, Mustansiriyah University

Baghdad, Al-karkh, 10011, Iraq

Location

Related 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. 2022 Apr-Jun;59(2):217-223. doi: 10.17219/dmp/143547.

  PMID: 35506381 BACKGROUND

• 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 arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4.

  PMID: 31279925 BACKGROUND

Related 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)

MeSH Terms

Interventions

silver diamine fluoride

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BDS

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 14, 2024
• Study Start: January 2, 2024
• Primary Completion: May 23, 2024
• Study Completion: July 1, 2024
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)