An interventional study of Group A: Chemo-Mechanical Caries Removal (CMCR) and Group 2 :Atraumatic Restorative Treatment in Carious Primary Molars, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 5 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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?
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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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 .
Participants in this arm will receive chemo-mechanical caries removal using REMOVE gel. The procedure includes cleaning the tooth surface with wet cotton pellets, application of REMOVE gel into the cavity, and allowing it to act for approximately 30 seconds. The softened carious tissue is then removed gently without pressure. Remaining Caries become fluorescence under light cure source, and the absence of color change indicates complete removal. Residual gel is removed using sterile wet cotton pellets. Finally, the cavity is restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions.
Other: Group A: Chemo-Mechanical Caries Removal (CMCR)
Participants in this arm will receive atraumatic restorative treatment (ART). The procedure involves opening the cavity and removal of carious dentin using a dental excavator . The cavity is clinically evaluated using a sharp explorer, and caries removal is considered complete when the explorer does not stick to dentin or produce a tug-back sensation. The cavity is then restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions.
Other: Group 2 :Atraumatic Restorative Treatment
Removal of dental caries using REMOVE gel followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
Removal of dental caries using hand instruments followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
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
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
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
Plan to share: No
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Cairo University