Evaluating the effectiveness of papain-based agents for removing dental caries in children
Clinical Evaluation and Antimicrobial Effect of Papain Based Chemo-mechanical Caries Removal Agents in Young Permanent Molars (A Randomized Controlled Clinical Trial)
NA · Alexandria University · NCT05983900
This study is testing if papain-based treatments can safely and effectively remove cavities in children aged 8 to 10, compared to the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 8 Years to 10 Years |
| Sex | All |
| Sponsor | Alexandria University (other) |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT05983900 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation focuses on the use of papain-based chemo-mechanical caries removal agents, specifically Brix 3000 and Papacarie duo gel, to treat deep carious lesions in children aged 8 to 10. The study compares these agents to the traditional Atraumatic Restorative Treatment (ART) hand excavation method in terms of time efficiency, patient pain response, radiographic success, and antimicrobial effects. Participants will undergo microbiological analysis of dentin samples before and after the caries removal procedure to assess the effectiveness of the treatments. The goal is to promote minimally invasive dentistry while preserving healthy dental tissue.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children aged 8 to 10 with at least one deep carious class 1 lesion in their first permanent molar.
Not a fit: Children with signs of pulpal infection, pain from caries, or special health care needs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less painful and more effective method for treating dental caries in children.
How similar studies have performed: Previous studies have shown promise in using chemo-mechanical methods for caries removal, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy children aged 8-10 years old. 2. The presence of at least one deep carious class 1 lesion in the first permanent molar with a score of 5 or 6 according to the International Detection and Assessment System (ICDAS), detected by visual-tactile inspection to assess lesion severity Exclusion Criteria: 1. Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling or abscess. 2. Pulpal exposure or bleeding during the excavation procedure 3. Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow. 4. Allergy or sensitivity to any of the materials included in the study
Where this trial is running
Alexandria
- Faculty of Dentistry — Alexandria, Egypt (RECRUITING)
Study contacts
- Study coordinator: Passant HM Hassanein, MSC
- Email: passant.metwally@alexu.edu.eg
- Phone: +201007749463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Caries