Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID04527705

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

Led by Universitat Internacional de Catalunya · Updated on 2020-08-26

110

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the success rate of non-surgical root canal retreatment performed in one visit compared to two visits in patients with periapical disease who require retreatment due to endodontic failure. This randomized controlled study aims to determine if there is any significant difference in treatment outcomes over a follow-up period of up to 10 years. The study is led by Universitat Internacional de Catalunya and focuses on endodontic diseases including root canal infection and endodontically treated teeth. Participants will receive non-surgical root canal retreatment either in a single visit or two separate visits. The study groups are randomized and treatment is administered by dental professionals following standardized procedures. The study monitors patients immediately after treatment and at several intervals up to 10 years to assess both clinical signs and radiographic evidence related to periapical disease. During the study, participants will be assessed for post-operative pain at various times: immediately, 4 hours, 24 hours, and 48 hours after treatment. Clinical symptoms and radiographic changes related to apical periodontitis will be evaluated at 1, 2, 4, 6, and 10 years. Researchers will also study correlations between prognostic factors and clinical outcomes. Safety and treatment success will be monitored over the long term, requiring participants to attend scheduled follow-up visits throughout the study period.

CONDITIONS

Brief Title

Outcome of Endodontic Retreatment in One or Two Visits

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who understand the study and willingly provide signed informed consent
  • Willingness to comply with all study procedures and restrictions
  • No clinically significant abnormalities in medical history or oral exam
  • Cases of retreatment due to endodontic failure
  • Diagnosis of apical periodontitis
  • Single or bi-radicular teeth requiring retreatment
Not Eligible

You will not qualify if you...

  • Patients with systemic diseases, diabetes, immunocompromised status, or pregnancy
  • Presence of clinically significant or relevant oral abnormalities
  • Root resorption or root fractures
  • Impossibility of restoration
  • Cases where secondary root canal treatment is not the treatment of choice

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 to 2 visits

Participants receive non-surgical root canal retreatment, either in one or two visits depending on their assigned group.

1 to 2 visits (in-person)

Follow-up

Duration - Up to 10 years

Participants are monitored for clinical signs or symptoms of periapical disease and radiographic changes over several years after treatment.

Multiple visits for assessments at 1, 2, 4, 6, and 10 years post-treatment

Trial Site Locations

Total: 1 location

1

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain, 08195

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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