Endodontically Treated Teeth, Endodontic Disease, Root Canal Infection
Conditions
Keywords
Primary root canal treatment, Secondary root canal treatment, Periapical healing, Outcome
Brief summary
This study is a prospective randomized controlled study of patients who come to the University and non-surgical root canal retreatment is considered as the election of choice in presence of periapical disease. The aim is to evaluate the success rate of non-surgical retreatment performed in one compared to two visit treatment up to 10 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of success, when performing root canal non-surgical retreatment in one or two visits.
Interventions
PROCEDURENon-surgical root canal retreatment
Non-surgical root canal retreatment
Sponsors
Universitat Internacional de Catalunya
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
No
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. * Retreatment cases due to an endodontic failure. * Diagnosis of apical periodontitis. * 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 secondary root canal treatment is not the treatment of choice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic periapical absence/presence/changes in radiographic apical periodontitis | 2 years | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph |
| Clinical signs or symptoms of periapical disease 2 | 2 years | Absence/presence of clinical signs or symptoms of periapical disease |
| Clinical signs or symptoms of periapical disease 4 | 4 years | Absence/presence of clinical signs or symptoms of periapical disease |
| Clinical signs or symptoms of periapical disease 6 | 6 years | Absence/presence of clinical signs or symptoms of periapical disease |
| Clinical signs or symptoms of periapical disease 10 | 10 years | Absence/presence of clinical signs or symptoms of periapical disease |
| Radiographic periapical absence/presence of radiographic apical periodontitis | 1 year | Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph |
| Clinical post-operative pain | Immediately post treatment | VAS score (0-10) of patient' level of pain, from no pain to extreme pain |
| Clinical signs or symptoms of periapical disease 1 | 1 year | Absence/presence of clinical signs or symptoms of periapical disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 2 | 2 years | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease |
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 4 | 4 years | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease |
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 6 | 6 years | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease |
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 10 | 10 years | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease |
| Correlation of prognostic factors and clinical signs or symptoms of periapical disease 1 | 1 year | Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease |
Countries
Spain
Outcome results
None listed