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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07605689
Enrollment
28
Registered
2026-05-26
Start date
2026-09-01
Completion date
2026-10-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carious Primary Molars

Brief summary

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

OTHERGroup 2 :Atraumatic Restorative Treatment

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

OTHERGroup A: Chemo-Mechanical Caries Removal (CMCR)

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Statistician

Eligibility

Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

1. Healthy children aged between 5 and 9 years. 2. Children presenting with occlusal caries in mandibular and/or maxillary primary molars Carious lesions without any pulpal involvement. 3. 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 .

Design outcomes

Primary

MeasureTime frameDescription
Pain Perception Measured by Visual Analog Scale (VAS)immediately after caries removalPain 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

MeasureTime frameDescription
Patient Acceptability Assessed by Likert ScaleImmediately after treatment procedurePatient 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

Countries

Egypt

Contacts

CONTACTMaram Malik Osman Alabd, Bachelor of dental science
maram.alabd@dentistry.cu.edu.eg00201279666507
CONTACTManal Ahmed Elsheikh, prof, PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026