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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Other: Cera-bur; Other: E-SDF; Other: Brix3000

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Al-karkh
    • Baghdad, Al-karkh, Iraq, 10011
      • College of Dentistry, Mustansiriyah University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ceramic bur (Cerabur) C; Cera bur (Ceramic Bur) Komet, Lemgo, Germany	Other: Cera-bur; Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material; Other Names: Ceramic bur
Active Comparator: Silver Diamine Fluoride (e-SDF) S; e-SDF (SDF 38%) E-kids, India	Other: E-SDF; Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling; Other Names: 38% Silver Diamine fluoride
Active Comparator: CMCR gel (Brix3000) B; Brix3000 (Papain based gel) S.R.L., Argentina	Other: Brix3000; Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material; Other Names: Papain-based CMCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful 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)

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): May 23, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: SDF; CMCR; Ceramic bur
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: MUPRU004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No