Actively Recruiting
The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study
Led by Juan Gonzalo Olivieri · Updated on 2020-08-31
220
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the success rates of initial and repeat root canal treatments using two different sealers: BioRoot RCS and AH Plus. This prospective randomized controlled study aims to compare these sealers over a follow-up period of up to six years to see if there are significant differences in treatment success. The study focuses on patients diagnosed with irreversible pulpitis or apical periodontitis, including retreatment cases due to previous endodontic failure. Participants will receive either primary or secondary root canal treatment sealed with gutta-percha combined with either BioRoot RCS or AH Plus root canal sealers. The study groups are randomized to assess and compare the outcomes of these two sealers. Treatments are performed according to standard endodontic procedures, and follow-up assessments will take place over several years to monitor healing and treatment success. During the study, participants will undergo evaluations of clinical post-operative pain at multiple time points immediately after treatment and up to 48 hours later. Clinical signs or symptoms of periapical disease and radiographic healing will be assessed at 1, 2, 4, and 6 years post-treatment. Researchers will also analyze how prognostic factors correlate with clinical and radiographic outcomes throughout the follow-up period. Participants' involvement may last up to six years, including regular check-ups and imaging studies to monitor long-term treatment results.
CONDITIONS
Brief Title
Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who understand the study and willingly sign informed consent
- Willingness to comply with all study procedures and restrictions
- No clinically significant abnormalities in medical history or oral exam
- Diagnosis of irreversible pulpitis or apical symptomatic/asymptomatic periodontitis
- Retreatment cases due to previous endodontic failure
- Treatment involves single or bi-radicular teeth
You will not qualify if you...
- Patients with systemic diseases, diabetes, immunocompromised, or pregnant women
- Presence of clinically significant oral abnormalities
- Cases with root resorption or root fractures
- Cases where restoration is not possible
- Situations where root canal treatment is not the appropriate option
AI-Screening
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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 treatment session with immediate post-treatment assessments
Participants undergo primary or secondary root canal treatment sealed with either BioRoot RCS® or AH Plus® root canal sealers.
1 visit (in-person) for treatment and immediate post-treatment pain assessment
Duration - Up to 6 years
Participants are monitored for clinical signs or symptoms of periapical disease and radiographic periapical healing over several years.
Visits at 4 hours, 24 hours, 48 hours post-treatment; and follow-up visits at 1 year, 2 years, 4 years, and 6 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
2
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