Outcome of Endodontic Retreatment in One or Two Visits

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04527705
• Other study ID #: UICENDECL201501
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: July 20, 2031

Study information

• Verified date: August 2020
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 20, 2031
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Endodontically Treated Teeth
• Root Canal Infection
• Tooth, Nonvital

Intervention

Procedure:
• Non-surgical root canal retreatment
Non-surgical root canal retreatment

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat Del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

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