Carious Tissue Selective Removal on Permanent Posterior Teeth.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJuan Gonzalo Olivieri
About this trial
This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of selective removal of carious tissue in deep lesions of posterior teeth. Three different materials will be used as liners (VitreBond ™Plus, BioDentine™, and Theracal™ LC). Post-operative pain, clinical, and radiographic success will be evaluated at one, two, and five-year follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment with the three materials used.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
Understands and is willing to comply with all study procedures and restrictions.
Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
Diagnosis of normal pulp or reversible pulpitis.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Carious tissue selective removal
Procedure/SurgeryCarious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration
Treatment groups
111 Participants
are divided into 3 treatment groupsGroup A: VitreBond LCExperimental treatment 1 intervention
Group B: BiodentineExperimental treatment 1 intervention
Group C: TheracalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Time frame
Immediately post-treatment2
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Time frame
8 hours post-treatment3
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Time frame
24 hours post-treatment4
Clinical post-operative pain
VAS score of patient' level of pain, from no pain to extreme pain
Time frame
48 hours post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Juan Gonzalo Olivieri
Lead sponsor
Universitat Internacional de Catalunya
Sponsor institution
Source ClinicalTrials.gov