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NCT Number: NCT04528979

Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of treatment and retreatment of canals using BioRoot ™ RCS cement compared with AH Plus up to 6 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment of root canals filled with BioRoot ™ RCS compared to gutta-percha and AH Plus sealer.

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Endodontically Treated Teeth 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: Yes

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.
  • Diagnosis of irreversible pulpitis or apical symptomatic / asymptomatic periodontitis.
  • Retreatment cases due to an endodontic failure.
  • 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 primary or secondary root canal treatment is not the treatment of choice.

Treatment and study plan

BioRoot RCS® root canal sealer

Other

Root canal obturation with guttapercha and BioRoot RCS® root canal sealer

AH Plus® root canal sealer

Other

Root canal obturation with guttapercha and AH Plus® root canal sealer

Primary outcomes

  1. Clinical post-operative pain

    Time frame: Immediately post-treatment.

    VAS score of patient' level of pain, from no pain to extreme pain

  2. Clinical post-operative pain

    Time frame: 4 hours post-treatment

    VAS score of patient' level of pain, from no pain to extreme pain

  3. Clinical post-operative pain

    Time frame: 24 hours post treatment

    VAS score of patient' level of pain, from no pain to extreme pain

  4. Clinical post-operative pain

    Time frame: 48 hours post treatment

    VAS score of patient' level of pain, from no pain to extreme pain

  5. Clinical signs or symptoms of periapical disease

    Time frame: 1 year

    Absence/presence of clinical signs or symptoms of periapical disease

  6. Clinical signs or symptoms of periapical disease

    Time frame: 2 years

    Absence/presence of clinical signs or symptoms of periapical disease

  7. Clinical signs or symptoms of periapical disease

    Time frame: 4 years

    Absence/presence of clinical signs or symptoms of periapical disease

  8. Clinical signs or symptoms of periapical disease

    Time frame: 6 years

    Absence/presence of clinical signs or symptoms of periapical disease

  9. Radiographic periapical healing

    Time frame: 1 year

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

  10. Radiographic periapical healing

    Time frame: 2 years

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

  11. Radiographic periapical healing

    Time frame: 4 years

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

  12. Radiographic periapical healing

    Time frame: 6 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

    Time frame: 1 year

    Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having clinical signs or symptoms of periapical disease

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

    Time frame: 2 years

    Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having clinical signs or symptoms of periapical disease

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

    Time frame: 4 years

    Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having clinical signs or symptoms of periapical disease

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

    Time frame: 6 years

    Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with having clinical signs or symptoms of periapical disease

  5. Correlation of prognostic factors and radiographic periapical healing

    Time frame: 1 year

    Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to radiographic periapical Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing

  6. Correlation of prognostic factors and radiographic periapical healing

    Time frame: 2 years

    Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing

  7. Correlation of prognostic factors and radiographic periapical healing

    Time frame: 4 years

    Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing

  8. Correlation of prognostic factors and radiographic periapical healing

    Time frame: 6 years

    Correlation of Pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist with radiographic periapical healing

Sponsors and collaborators

Lead sponsor

Juan Gonzalo Olivieri

Other

Registry information

Official study title

The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2027
First posted
Aug 27, 2020
Registry last updated
Aug 31, 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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