Outcome of Endodontic Retreatment in One or Two Visits

Not Applicable

Recruiting

• Conditions: Endodontically Treated Teeth; Endodontic Disease; Root Canal Infection
• Interventions: Procedure: Non-surgical root canal retreatment

• Registration Number: NCT04527705
• Lead Sponsor: Universitat Internacional de Catalunya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-20
• Status Verified: 2020-08
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-23
• Last Update Submitted: 2020-08-23
• Study First Posted: 2020-08-26
• Last Update Posted: 2020-08-26
• Primary Completion: 2021-07-20
• Study Completion: 2031-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-vist endodontic retreatment	Non-surgical root canal retreatment	Non-surgical root canal retreatment performed in two visits
1-vist endodontic retreatment	Non-surgical root canal retreatment	Non-surgical root canal retreatment performed in one visit

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation of prognostic factors and clinical signs or symptoms of periapical disease 1	1 year	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	6 years	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	2 years	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	4 years	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	10 years	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

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat Del Vallès, Barcelona, Spain