Outcome of Endodontic Retreatment in One or Two Visits

Clinical and Radiographic Outcome of Endodontic Retreatment in One or Two Visits: A Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Endodontic Disease; Endodontically Treated Teeth; Root Canal Infection
• Intervention / Treatment: Procedure: Non-surgical root canal retreatment

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08195
      • Recruiting
      • Universitat Internacional de Catalunya
      • Contact: Juan G. Olivieri, DDS, PhD; Phone Number: 935042000; Email: jgolivieri@uic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1-vist endodontic retreatment; Non-surgical root canal retreatment performed in one visit	Procedure: Non-surgical root canal retreatment; Non-surgical root canal retreatment
Active Comparator: 2-vist endodontic retreatment; Non-surgical root canal retreatment performed in two visits	Procedure: Non-surgical root canal retreatment; Non-surgical root canal retreatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical post-operative pain	VAS score (0-10) of patient' level of pain, from no pain to extreme pain	Immediately post treatment
Clinical post-operative pain	VAS score (0-10) of patient' level of pain, from no pain to extreme pain	4 hours post-treatment
Clinical post-operative pain	VAS score (0-10) of patient' level of pain, from no pain to extreme pain	24 hours post treatment
Clinical post-operative pain	VAS score (0-10) of patient' level of pain, from no pain to extreme pain	48 hours post treatment
Clinical signs or symptoms of periapical disease 1	Absence/presence of clinical signs or symptoms of periapical disease	1 year
Clinical signs or symptoms of periapical disease 2	Absence/presence of clinical signs or symptoms of periapical disease	2 years
Clinical signs or symptoms of periapical disease 4	Absence/presence of clinical signs or symptoms of periapical disease	4 years
Clinical signs or symptoms of periapical disease 6	Absence/presence of clinical signs or symptoms of periapical disease	6 years
Clinical signs or symptoms of periapical disease 10	Absence/presence of clinical signs or symptoms of periapical disease	10 years
Radiographic periapical absence/presence of radiographic apical periodontitis	Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph	1 year
Radiographic periapical absence/presence/changes in radiographic apical periodontitis	Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph	2 years
Radiographic periapical absence/presence/changes in radiographic apical periodontitis	Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph	4 years
Radiographic periapical absence/presence/changes in radiographic apical periodontitis	Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph	6 years
Radiographic periapical absence/presence/changes in radiographic apical periodontitis	Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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	2 years
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	4 years
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	6 years
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 10	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	10 years

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Anticipated): July 20, 2021
• Study Completion (Anticipated): July 20, 2031

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Outcome; Primary root canal treatment; Secondary root canal treatment; Periapical healing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: UICENDECL201501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No