Outcome of Endodontic Retreatment in One or Two Visits
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversitat Internacional de Catalunya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Non-surgical root canal retreatment
Procedure/SurgeryNon-surgical root canal retreatment
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: 1-vist endodontic retreatmentActive comparator 1 intervention
Group B: 2-vist endodontic retreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical post-operative pain
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Time frame
Immediately post treatment2
Clinical post-operative pain
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Time frame
4 hours post-treatment3
Clinical post-operative pain
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Time frame
24 hours post treatment4
Clinical post-operative pain
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Time frame
48 hours post treatmentSecondary outcomes
1
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 1
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
Time frame
1 year2
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 2
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
Time frame
2 years3
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 4
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
Time frame
4 years4
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 6
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
Time frame
6 yearsSponsors and contacts
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Source ClinicalTrials.gov