Outcome of Endodontic Retreatment in One or Two Visits

Universitat Internacional de Catalunya110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Endodontic Disease Endodontically Treated Teeth Root Canal Infection

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical post-operative pain

VAS score (0-10) of patient' level of pain, from no pain to extreme pain

Time frame: Immediately post treatment

Clinical post-operative pain

VAS score (0-10) of patient' level of pain, from no pain to extreme pain

Time frame: 4 hours post-treatment

Clinical post-operative pain

VAS score (0-10) of patient' level of pain, from no pain to extreme pain

Time frame: 24 hours post treatment

Clinical post-operative pain

VAS score (0-10) of patient' level of pain, from no pain to extreme pain

Time frame: 48 hours post treatment

Clinical signs or symptoms of periapical disease 1

Absence/presence of clinical signs or symptoms of periapical disease

Time frame: 1 year

Clinical signs or symptoms of periapical disease 2

Absence/presence of clinical signs or symptoms of periapical disease

Time frame: 2 years

Clinical signs or symptoms of periapical disease 4

Absence/presence of clinical signs or symptoms of periapical disease

Time frame: 4 years

Clinical signs or symptoms of periapical disease 6

Absence/presence of clinical signs or symptoms of periapical disease

Time frame: 6 years

Clinical signs or symptoms of periapical disease 10

Absence/presence of clinical signs or symptoms of periapical disease

Time frame: 10 years

Radiographic periapical absence/presence of radiographic apical periodontitis