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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
RECRUITINGvisual examination
Clinical examination.Data will be recorded in terms of clinical signs of success.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination.
Time frame: 12 months
Radiographic Success
RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis or pathology root resorption.
Time frame: 12 months
Radicular Radiolucency
RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.
Time frame: 12 months
Internal Resorption
RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.
Time frame: 12 months
External Resorption
RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.
Time frame: 12 months
Furcation Radiolucency
RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.
Time frame: 12 months
Symptoms of pain
Clinical examination,The patient will be recalled for control . Data will be recorded in terms of presence of symptoms, clinical and radiographic signs of success / failure, vertical and lateral percussion, periodontal probing and periapical and bitewing be implemented following the same methodology as in the initial evaluation.Clinical failure was determined by the subjective symptoms as explained by the participants.
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Time frame: 12 months
Swelling
Clinical examination . Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including swelling.
Time frame: 12 months
Fistulation
Clinical and RX examination,The patient will be recalled for control .Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including abscess.
Time frame: 12 months
Pathological Mobility
Clinical examination,The patient will be recalled for control.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including mobility.
Time frame: 12 months