Reversible Pulpitis Clinical Trial
Official title:
Randomized Blind Clinical Trial, Two-armed, Parallel of Indirect Pulp Capping With Biodentine and TheraCal LC in Permanent Mature Molars With Deep Carious Lesions
NCT number | NCT03741816 |
Other study ID # | 1/2018 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 7, 2019 |
Est. completion date | January 2022 |
Management of deep carious lesions in permanent mature molars with reversible pulpitis
represents a challenge for clinicians. Vital pulp therapy includes indirect and direct pulp
capping, partial pulpotomy and full pulpotomy. Indirect pulp capping is a procedure in which
a material is placed on a thin layer of remaining soft dentin that, if removed, might expose
the pulp. The objective is dentin bridge formation and pulp vitality preservation.
The aim of this randomized clinical trial is to evaluate the success rate of indirect pulp
capping with Biodentine and TheraCal LC in mature permanent molars with deep carious lesions
at one-year follow-up examination. The null hypothesis tested will be that there is no
statistically significant difference in success rate between both materials in indirect pulp
capping of permanent mature molars with deep carious lesions.
Status | Recruiting |
Enrollment | 212 |
Est. completion date | January 2022 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Patient = 18 years without any systemic disease. 2. Presence of a deep carious lesion in a permanent mature molar without periapical pathology that penetrates radiographically into the inner dentin half or even third/ quarter. 3. Preoperative diagnosis of reversible pulpitis. 4. After selective caries removal to soft dentin with a high-speed diamond bur and Cariosolv gel and hand instruments, no pulpal exposure occurred. Exclusion Criteria: 1. Negative response to pulp sensibility tests. 2. Clinical symptoms of irreversible pulpitis or pulp necrosis. 3. Presence of fistula, swelling, tenderness to percussion, tooth mobility. 4. Presence of periapical pathology on periapical radiographs (internal or external root resorption, abscence of normal appearance of periodontal ligament, presence of interradicular or periapical radiolucencies). 5. Pregnant women. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response to pulp sensibility testing ( thermal and electric pulp testing) | abscence of clinical signs and/or symptoms and radiographic findings of pulp degeneration | one year |
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