Clinical trial NCT06412731: Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: CMCR
SDF
Ceramic bur
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse event
timeFrame: during the first two weeks
measure: Filling fellow up
timeFrame: after 3 months
Secondary outcomes:
measure: anxiety level
timeFrame: immediately after the procedure
measure: Time
timeFrame: This will take about from 5 to 30 minutes
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry, Mustansiriyah University
state: Al-karkh
Study officials:
References:
citation: 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.
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 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.