About this trial
The goal of this clinical trial is to compare pain Perception, patient acceptability, and cavity preparation time between chemo-mechanical caries removal and Atraumatic restorative treatment Method in Primary Molars.
The main questions it aims to answer: "Does chemo-mechanical caries removal show similar results compared to Atraumatic restorative treatment Method in terms of pain perception in Primary Molars?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy children aged between 5 and 9 years.
Children presenting with occlusal caries in mandibular and/or maxillary primary molars Carious lesions without any pulpal involvement.
Children whose parents or guardians have provided written informed consent.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Group A: Chemo-Mechanical Caries Removal (CMCR)
Other interventionRemoval of dental caries using REMOVE gel followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
Group 2 :Atraumatic Restorative Treatment
Other interventionRemoval of dental caries using hand instruments followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
Treatment groups
Trial outcomes
Primary outcomes
Pain Perception Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). Higher scores represent greater pain intensity. 0: No pain 1-3: mild 4-5: moderate 6-7: Severe 8-9: very severe 10: Worst Pain possible
Secondary outcomes
Patient Acceptability Assessed by Likert Scale
Patient acceptability will be evaluated using a 5-point Likert Scale ranging from 1 to 5, where 1 indicates very happy and 5 indicates very unhappy. Higher scores indicate lower patient acceptability. 1. Very Happy 2. Happy 3. Neither 4. Unhappy 5. Very Unhappy
Other outcomes
Caries removal time measured by stopwatch per minutes
The duration of the treatment procedure will be measured in minutes from the beginning of caries removal until completion of the restorative procedure. Higher values indicate longer treatment time.
Sponsors and contacts
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