Faulty of Dentistry Cairo University
Cairo, 12613, Egypt
NCT Number: NCT07605689
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?
Trial opening soon.
Get Notified5 year–9 year
All sexes
Interventional
Not applicable
Cairo, 12613, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 .
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)
Time frame: immediately after caries removal
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 treatment procedure
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.
Time frame: During the caries removal procedure
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.
Contact information is provided by the study sponsor or research team.
Manal Ahmed Elsheikh, prof, PhD
CONTACT
Maram Malik Osman Alabd, Bachelor of dental science
CONTACT
Cairo University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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