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

NCT07605689 | Not Yet Recruiting

• 1 other identifier: PP-NCV-VSART
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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?

Conditions

Carious Primary Molars

Outcome Measures

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

  immediately after caries removal

Secondary Outcomes (1)

• Patient Acceptability Assessed by Likert Scale

  Immediately after treatment procedure

Other Outcomes (1)

• Caries removal time measured by stopwatch per minutes

  During the caries removal procedure

Study Arms (2)

Group A: Chemo-Mechanical Caries Removal (CMCR)

EXPERIMENTAL

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)

Group B: Atraumatic Restorative Treatment (ART)

EXPERIMENTAL

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

Interventions

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

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

Group A: Chemo-Mechanical Caries Removal (CMCR)

Group 2 :Atraumatic Restorative Treatment OTHER

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

Group B: Atraumatic Restorative Treatment (ART)

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faulty of Dentistry Cairo University

Cairo, 12613, Egypt

Location

Related Publications (1)

• -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

  BACKGROUND

Central Study Contacts

Maram Malik Osman Alabd, Bachelor of dental science

CONTACT

00201279666507; maram.alabd@dentistry.cu.edu.eg

Manal Ahmed Elsheikh, prof, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)