Endodontically Treated Teeth, Endodontic Disease
Conditions
Keywords
Primary root canal treatment, Secondary root canal treatment, Outcome, Root canal sealer
Brief summary
This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of treatment and retreatment of canals using BioRoot ™ RCS cement compared with AH Plus up to 6 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment of root canals filled with BioRoot ™ RCS compared to gutta-percha and AH Plus sealer.
Interventions
OTHERBioRoot RCS® root canal sealer
Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
OTHERAH Plus® root canal sealer
Root canal obturation with guttapercha and AH Plus® root canal sealer
Sponsors
Juan Gonzalo Olivieri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 irreversible pulpitis or apical symptomatic / asymptomatic periodontitis. * Retreatment cases due to an endodontic failure. * Single or bi-radicular teeth.
Exclusion criteria
* General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities. * Specific: root resorption, root fractures, impossibility of restoration and cases were primary or secondary root canal treatment is not the treatment of choice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical post-operative pain | Immediately post-treatment. | VAS score of patient' level of pain, from no pain to extreme pain |
| Clinical signs or symptoms of periapical disease | 1 year | Absence/presence of clinical signs or symptoms of periapical disease |
| Radiographic periapical healing | 1 year | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease | 1 year | Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having clinical signs or symptoms of periapical disease |
| Correlation of prognostic factors and radiographic periapical healing | 1 year | Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to radiographic periapical Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing |
Countries
Spain
Outcome results
None listed