Pain Perception of Novel Chemo-mechanical Caries Remove Versus Atraumatic Restorative Treatment Method in Primary Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group A: Chemo-Mechanical Caries Removal (CMCR), Group 2 :Atraumatic Restorative Treatment.
- Who it may be relevant to
- Registry conditions: Carious Primary Molars. Basic parameters: 5 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
Detailed description
The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques "high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia
Atraumatic Restorative Treatment (ART) is one of the approaches based on this philosophy. It involves the manual removal of carious tissue without the use of local anesthesia or rotary instruments, followed by restoration with glass ionomer cement, an adhesive material that chemically bonds to tooth structure and releases fluoride, promoting remineralization.
Chemo mechanical caries removal (CMCR) is another minimally invasive technique that utilizes chemical agents with proteolytic action to degrade denatured collagen within carious dentin, facilitating its removal without the need for rotary instruments. This technique reduces pain, discomfort, and anxiety, making it particularly suitable for pediatric patients. Additionally, CMCR minimizes the risk of unnecessary removal of healthy tooth structure and may reduce the need for local anesthesia, thereby improving patient cooperation and the overall treatment experience.
Interventions
- Other Group A: Chemo-Mechanical Caries Removal (CMCR)
Removal of dental caries using REMOVE gel followed by restoration with high-viscosity glass ionomer cement (Fuji IX) - Other Group 2 :Atraumatic Restorative Treatment
Removal of dental caries using hand instruments followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
Primary outcome measures
- Pain Perception Measured by Visual Analog Scale (VAS) [Time frame: immediately after caries removal]
Secondary outcome measures (1)
- Patient Acceptability Assessed by Likert Scale [Time frame: Immediately after treatment procedure]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
1-Children with teeth exhibiting: pulpal exposure, mobility, spontaneous pain, swelling or fistula adjacent to the tooth, furcation involvement, ervical lesions, teeth with sealants, restorations, or enamel defects also exclude .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faulty of Dentistry Cairo University — Cairo
Publications
- -Abdel Sattar, R., Nasr, R., Hanafy, R. (2026). 'Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial', Egyptian Dental Journal, 72(1), pp. 25-33. doi: 10.21608/edj.2025.417407.3615
Identifiers
NCT: NCT07605689 · PP-NCV-VSART