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Outcome of Endodontic Retreatment in One or Two Visits

Primary Purpose

Endodontic Disease, Endodontically Treated Teeth, Root Canal Infection

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non-surgical root canal retreatment
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Disease focused on measuring Primary root canal treatment, Secondary root canal treatment, Periapical healing, Outcome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitat Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1-vist endodontic retreatment

2-vist endodontic retreatment

Arm Description

Non-surgical root canal retreatment performed in one visit

Non-surgical root canal retreatment performed in two visits

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
August 13, 2020
Last Updated
August 23, 2020
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT04527705
Brief Title
Outcome of Endodontic Retreatment in One or Two Visits
Official Title
Clinical and Radiographic Outcome of Endodontic Retreatment in One or Two Visits: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
July 20, 2021 (Anticipated)
Study Completion Date
July 20, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease, Endodontically Treated Teeth, Root Canal Infection
Keywords
Primary root canal treatment, Secondary root canal treatment, Periapical healing, Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1-vist endodontic retreatment
Arm Type
Active Comparator
Arm Description
Non-surgical root canal retreatment performed in one visit
Arm Title
2-vist endodontic retreatment
Arm Type
Active Comparator
Arm Description
Non-surgical root canal retreatment performed in two visits
Intervention Type
Procedure
Intervention Name(s)
Non-surgical root canal retreatment
Intervention Description
Non-surgical root canal retreatment
Primary Outcome Measure Information:
Title
Clinical post-operative pain
Description
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Time Frame
Immediately post treatment
Title
Clinical post-operative pain
Description
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Time Frame
4 hours post-treatment
Title
Clinical post-operative pain
Description
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Time Frame
24 hours post treatment
Title
Clinical post-operative pain
Description
VAS score (0-10) of patient' level of pain, from no pain to extreme pain
Time Frame
48 hours post treatment
Title
Clinical signs or symptoms of periapical disease 1
Description
Absence/presence of clinical signs or symptoms of periapical disease
Time Frame
1 year
Title
Clinical signs or symptoms of periapical disease 2
Description
Absence/presence of clinical signs or symptoms of periapical disease
Time Frame
2 years
Title
Clinical signs or symptoms of periapical disease 4
Description
Absence/presence of clinical signs or symptoms of periapical disease
Time Frame
4 years
Title
Clinical signs or symptoms of periapical disease 6
Description
Absence/presence of clinical signs or symptoms of periapical disease
Time Frame
6 years
Title
Clinical signs or symptoms of periapical disease 10
Description
Absence/presence of clinical signs or symptoms of periapical disease
Time Frame
10 years
Title
Radiographic periapical absence/presence of radiographic apical periodontitis
Description
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Time Frame
1 year
Title
Radiographic periapical absence/presence/changes in radiographic apical periodontitis
Description
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Time Frame
2 years
Title
Radiographic periapical absence/presence/changes in radiographic apical periodontitis
Description
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Time Frame
4 years
Title
Radiographic periapical absence/presence/changes in radiographic apical periodontitis
Description
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Time Frame
6 years
Title
Radiographic periapical absence/presence/changes in radiographic apical periodontitis
Description
Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 1
Description
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 year
Title
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 2
Description
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 years
Title
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 4
Description
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 years
Title
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 6
Description
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 years
Title
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 10
Description
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
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan G. Olivieri, DDS, PhD
Phone
935042000
Email
jgolivieri@uic.es

12. IPD Sharing Statement

Plan to Share IPD
No

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Outcome of Endodontic Retreatment in One or Two Visits

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