Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Adverse event
Study Overview
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:
- Arrestment of caries lesion and the emergence of a new one
- Time required for the treatment
- Adverse events
- 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:
- Duration of treatment
- (feeling of pain) and the need for anesthetic
- Incidents with negative outcomes that have been officially documented
- 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 8 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Adverse event
Time Frame: during the first two weeks
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
Filling fellow up
Time Frame: after 3 months
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
Secondary Outcomes
- anxiety level(immediately after the procedure)
- Time(This will take about from 5 to 30 minutes)
Investigators
Alhamzah thaer hasan Ankaz
BDS
Al-Mustansiriyah University