Evaluating pulpotomies in children's primary molars using tricalcium silicate cements
Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.
NA · Universitat Internacional de Catalunya · NCT04902495
This study is testing if different types of materials used in pulpotomies can help save children's back teeth and how well they work.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya (other) |
| Locations | 1 site (Sant Cugat del Valles, Barcelona) |
| Trial ID | NCT04902495 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the success rates of pulpotomies performed on primary molars in children, utilizing various hemostatic agents and pulp capping materials made from tricalcium silicates. Conducted at the Pediatric Dentistry Department of Universitat Internacional de Catalunya, the study will involve a randomized approach with a sample size of approximately 63 participants per group. Data will be collected and analyzed using statistical software to determine the effectiveness of the different materials used in the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years of age with asymptomatic, vital primary molars that have experienced pulp exposure during caries removal.
Not a fit: Patients with systemic health issues, significant oral abnormalities, or a history of allergic reactions to the study materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the outcomes of vital pulp therapy in children, leading to better dental health and reduced need for more invasive treatments.
How similar studies have performed: While there is ongoing research in the field of pediatric dentistry, this specific approach using tricalcium silicate cements in pulpotomies is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Responsible patients or parents or guardians who demonstrate that they understand the study and are willing to participate, as evidenced by signing the voluntary informed consent and receiving a signed and dated copy of the informed consent form. * Children under 18 years of age with informed parental consent, correctly understood. * Patient understands and is willing to comply with all study procedures and restrictions. * Absence of clinical and radiographic evidence of pulp degeneration such as excessive bleeding, internal and / or external root resorption, destruction of the furcation. * Asymptomatic and vital primary molars whose pulp exposure occurred during caries removal. Exclusion Criteria: * Patients with systemic pathologies (diabetes, inmunosuppresed or any clinically significant or relevant oral abnormality). * Previous history of allergic reaction to local anesthesics or to the different constituents of the pulp agents to be studied. * Pulp diagnosis of irreversible pulpits or pulp necrosis, root resorption, root fractures, pathological mobility, spontaneous pain, impossibility of restoration, and if pulpotomy is not the treatment of choice.
Where this trial is running
Sant Cugat del Valles, Barcelona
- Universitat Internacional de Catalunya — Sant Cugat del Valles, Barcelona, Spain (RECRUITING)
Study contacts
- Study coordinator: Francisco Guinot Jimeno, DDS, MsC
- Email: fguinot79@hotmail.com
- Phone: 0034 93 504 50 00
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: Primary Molar Pulpotomy