Comparing two methods for treating dental pulp disease in children's molars
Comparison and Effectiveness of the Manual File System, the Multi-file Rotating System and the Single File Reciprocating System in Temporal Molars
This study is testing two different ways to treat dental pulp disease in children's back teeth to see which method works better for kids aged 4 to 8.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 8 Years |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya Academic / other |
| Locations | 1 site (Sant Cugat del Vallès, Barcelona) |
| Trial ID | NCT04793477 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different instrumentation techniques, the reciprocating system Reciproc Blue and the rotating system VDW.ROTATE, in performing pulpectomies on primary molars in children aged 4 to 8 years. Conducted at the International University of Catalonia, the study involves a randomized controlled design with 60 participants divided into three groups, each receiving a different treatment approach. The students in the master's program in Pediatric Dentistry will perform the procedures under supervision, ensuring standardized training and calibration. Data will be collected and analyzed to determine the success rates of each technique.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 8 years with vital or non-vital temporary lower second molars that meet specific radiographic criteria.
Not a fit: Patients with systemic diseases, special needs, or those who are very uncooperative may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for children with pulp disease in their primary molars.
How similar studies have performed: Previous studies have shown varying success with different instrumentation techniques in pediatric dentistry, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Vital or non-vital temporary lower second molars. * Radiographic absence of external or internal pathological reabsorption. * Absence of interadicular radioluscience and/or periapical lesion. * Temporary teeth with at least 2/3 of the root intact or a minimum root length of 8mm. * Remaining dental structure sufficient for the subsequent placement of a stainless steel crown. * Children who have already undergone some previous restorative treatment in the Department of Pediatric Dentistry. Exclusion Criteria: * Molars that have less than 2/3 radicular lenght. * Have taken analgesics or anti-inflammatories in the last 12 hours. * Very uncooperative patients, who require some type of anxiety to be treated. * Patients with systemic diseases. * Patients with special needs.
Where this trial is running
Sant Cugat del Vallès, Barcelona
- Universitat Internacional de Catalunya — Sant Cugat del Vallès, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Francisco Guinot Jimeno, DDS, MsC
- Email: fguinot@uic.es
- Phone: 935042000
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.