Outcome of Endodontic Retreatment in One or Two Visits

NCT ID: NCT04527705

Last Updated: 2020-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2031-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Endodontic Disease Endodontically Treated Teeth Root Canal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1-vist endodontic retreatment

Non-surgical root canal retreatment performed in one visit

Group Type ACTIVE_COMPARATOR

Non-surgical root canal retreatment

Intervention Type PROCEDURE

Non-surgical root canal retreatment

2-vist endodontic retreatment

Non-surgical root canal retreatment performed in two visits

Group Type ACTIVE_COMPARATOR

Non-surgical root canal retreatment

Intervention Type PROCEDURE

Non-surgical root canal retreatment

Interventions

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Non-surgical root canal retreatment

Non-surgical root canal retreatment

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Juan Gonzalo Olivieri

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Juan G. Olivieri, DDS, PhD

Role: primary

935042000

Other Identifiers

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UICENDECL201501

Identifier Type: -

Identifier Source: org_study_id

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