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NCT Number: NCT04527705

Outcome of Endodontic Retreatment in One or Two Visits

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location status: Recruiting

Location contact

Juan G. Olivieri, DDS, PhD

CONTACT

[email protected]

935042000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Surgical Root Canal Retreatment

Procedure

Non-surgical root canal retreatment

Primary outcomes

  1. Clinical post-operative pain

    Time frame: Immediately post treatment

    VAS score (0-10) of patient' level of pain, from no pain to extreme pain

  2. Clinical post-operative pain

    Time frame: 4 hours post-treatment

    VAS score (0-10) of patient' level of pain, from no pain to extreme pain

  3. Clinical post-operative pain

    Time frame: 24 hours post treatment

    VAS score (0-10) of patient' level of pain, from no pain to extreme pain

  4. Clinical post-operative pain

    Time frame: 48 hours post treatment

    VAS score (0-10) of patient' level of pain, from no pain to extreme pain

  5. Clinical signs or symptoms of periapical disease 1

    Time frame: 1 year

    Absence/presence of clinical signs or symptoms of periapical disease

  6. Clinical signs or symptoms of periapical disease 2

    Time frame: 2 years

    Absence/presence of clinical signs or symptoms of periapical disease

  7. Clinical signs or symptoms of periapical disease 4

    Time frame: 4 years

    Absence/presence of clinical signs or symptoms of periapical disease

  8. Clinical signs or symptoms of periapical disease 6

    Time frame: 6 years

    Absence/presence of clinical signs or symptoms of periapical disease

  9. Clinical signs or symptoms of periapical disease 10

    Time frame: 10 years

    Absence/presence of clinical signs or symptoms of periapical disease

  10. Radiographic periapical absence/presence of radiographic apical periodontitis

    Time frame: 1 year

    Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph

  11. Radiographic periapical absence/presence/changes in radiographic apical periodontitis

    Time frame: 2 years

    Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph

  12. Radiographic periapical absence/presence/changes in radiographic apical periodontitis

    Time frame: 4 years

    Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph

  13. Radiographic periapical absence/presence/changes in radiographic apical periodontitis

    Time frame: 6 years

    Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph

  14. Radiographic periapical absence/presence/changes in radiographic apical periodontitis

    Time frame: 10 years

    Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2031
First posted
Aug 26, 2020
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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