Actively Recruiting
Carious Tissue Selective Removal on Permanent Posterior Teeth. A Randomized Controlled Clinical Study.
Led by Juan Gonzalo Olivieri · Updated on 2020-08-31
111
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized controlled study to evaluate the success of selectively removing decayed tissue from deep cavities in permanent back teeth. The study compares three different liner materials: VitreBond Plus, BioDentine, and Theracal LC, to see if there are differences in treatment success. Patients will be followed up for one, two, and five years to assess results, including post-treatment pain and clinical and X-ray signs of dental health. Participants will undergo a procedure where decayed tissue is selectively removed from deep lesions in posterior teeth. After this, one of the three liners will be applied under a final composite tooth restoration. The study groups correspond to each liner material being tested. This design is double-blinded and randomized, ensuring unbiased evaluation of each material. During the study, participants will be monitored for pain immediately after treatment and at intervals up to 48 hours. Further clinical and radiographic checks will occur at one, two, and five years to observe any signs of pulp or periapical disease. The trial involves regular dental exams and imaging to track treatment success and safety over time. The total participation duration spans up to five years after treatment.
CONDITIONS
Brief Title
Carious Tissue Selective Removal on Permanent Posterior Teeth.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who understand the study and agree to participate by signing informed consent
- Willingness to comply with all study procedures and restrictions
- No clinically significant or relevant abnormalities in medical history or oral exam
- Diagnosis of normal pulp or reversible pulpitis
- No periapical periodontitis present
- Posterior teeth involved
You will not qualify if you...
- Patients with systemic diseases, diabetes, or immunocompromised conditions
- Pregnant women
- Presence of clinically significant or relevant oral abnormalities
- Teeth that cannot be restored
- Diagnosis of irreversible pulpitis or pulp necrosis
- Presence of preoperative pain
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-treatment period
Participants undergo selective removal of carious tissue in posterior teeth and receive one of three liners (VitreBond LC, Biodentine, or Theracal) under a composite restoration.
1 treatment visit and 3 follow-up visits within 48 hours
Duration - Up to 5 years
Participants are monitored for clinical and radiographic signs of pulp or periapical disease over several years after treatment.
Follow-up visits at 1 year, 2 years, 4 years, and 5 years
Trial Site Locations
Total: 1 location
1
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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