Outcome of Endodontic Retreatment in One or Two Visits

NCT04527705 | Recruiting DMC

• 1 other identifier: UICENDECL201501
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Disease; Endodontically Treated Teeth; Root Canal Infection

Keywords

Primary root canal treatment; Secondary root canal treatment; Periapical healing; Outcome

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (5)

• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 1

  1 year

• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 2

  2 years

• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 4

  4 years

• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 6

  6 years

• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 10

  10 years

Study Arms (2)

1-vist endodontic retreatment

ACTIVE COMPARATOR

Non-surgical root canal retreatment performed in one visit

Procedure: Non-surgical root canal retreatment

2-vist endodontic retreatment

ACTIVE COMPARATOR

Non-surgical root canal retreatment performed in two visits

Procedure: Non-surgical root canal retreatment

Interventions

Non-surgical root canal retreatment PROCEDURE

Non-surgical root canal retreatment

1-vist endodontic retreatment; 2-vist endodontic retreatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases; Tooth, Nonvital

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 26, 2020
• Study Start: September 20, 2018
• Primary Completion: July 20, 2021
• Study Completion (Estimated): July 20, 2031
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)