Clinical trial NCT04902495: Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements
Official title: Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Molar Pulpotomy
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 61
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the success rate of pulpotomies in temporary molars using different types of hemostats and pulp coating materials based on tricalcium silicates, in patients who have attended the Dental Clinic of the International University of Catalonia (UIC).

Detailed description: This prospective randomized clinical trial study has been approved by the

Scientific Committee in January of 2017 and by Ethics Committee (END-ECL- 2017-01) . It will be conducted in patients needing a vital pulp

therapy treatment at the Pediatric Dentistry Department of Universitat Internacional de Catalunya (Sant Cugat del Vallés, Barcelona, Spain). The necessary statistical sample size assuming an alpha risk of 0.05, a beta risk of 0.05 and a power of 95% sample, the required sample obtained by group resulted in 52. Given an estimate upwards of 20% of drop-outs in controls, the final size results in 62.4 (63 cases per group).

The data collection will be recollected using Excel program. Statgraphics Centurion XV software (StatPoint Technologies, Inc., Warrenton, VA, USA) will be used for statistical analysis. The chi-square test will be used and logistic regression analysis of the results will be performed to assess differences between groups with a significance level of P \<0.05.

Eligibility 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.

Primary outcomes:
measure: visual examination
timeFrame: 12 months
measure: Radiographic Success
timeFrame: 12 months
Secondary outcomes:
measure: Radicular Radiolucency
timeFrame: 12 months
measure: Internal Resorption
timeFrame: 12 months
measure: External Resorption
timeFrame: 12 months
measure: Furcation Radiolucency
timeFrame: 12 months
measure: Symptoms of pain
timeFrame: 12 months
measure: Swelling
timeFrame: 12 months
measure: Fistulation
timeFrame: 12 months
measure: Pathological Mobility
timeFrame: 12 months
Other outcomes:
Locations:
city: Sant Cugat del Valles
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References: