Pain Perception of Novel Chemo-mechanical Caries Remove Versus Atraumatic Restorative Treatment Method in Primary Molars

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-9
SponsorCairo University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Group A: Chemo-Mechanical Caries Removal (CMCR)

    Other intervention

    Removal of dental caries using REMOVE gel followed by restoration with high-viscosity glass ionomer cement (Fuji IX)

  • Group 2 :Atraumatic Restorative Treatment

    Other intervention

    Removal of dental caries using hand instruments followed by restoration with high-viscosity glass ionomer cement (Fuji IX)

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Group A: Chemo-Mechanical Caries Removal (CMCR)Experimental treatment 1 intervention
Group B: Group B: Atraumatic Restorative Treatment (ART)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
immediately after caries removal

Secondary outcomes

1

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

Time frame
Immediately after treatment procedure

Other outcomes

1

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.

Time frame
During the caries removal procedure

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: