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RecruitingNCT04528979Updated Aug 31, 2020

Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

An interventional study of BioRoot RCS® root canal sealer and AH Plus® root canal sealer in Endodontic Disease and Endodontically Treated Teeth, sponsored by Juan Gonzalo Olivieri. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-31.

Sponsored by Juan Gonzalo Olivieri · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2021, 5 years 9 months ago, but the record still lists the study as recruiting.
  • Registered 8 months after the study started (first participant enrolled Sep 2019, registered May 2020).
  • Started Sep 2019; still recruiting 7 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Endodontic Disease
  • Endodontically Treated Teeth

Keywords

  • Primary root canal treatment
  • Secondary root canal treatment
  • Outcome
  • Root canal sealer
03

In context

Tooth, Nonvital

113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.

This study's planned enrollment of 220 is above the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

Juan Gonzalo Olivieri is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Primary root canal treatment

    Primary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers

    Other: BioRoot RCS® root canal sealer · Other: AH Plus® root canal sealer

  • Experimental
    Secondary root canal treatment

    Secondary root canal treatment sealed with guttapercha and AH Plus® or BioRoot RCS® root canal sealers

    Other: BioRoot RCS® root canal sealer · Other: AH Plus® root canal sealer

Interventions

  • OtherBioRoot RCS® root canal sealer

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

  • OtherAH Plus® root canal sealer

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

06

What researchers measure

Primary outcomes

  1. Clinical post-operative pain

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

    Time frame: Immediately post-treatment.

  2. Clinical post-operative pain

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

    Time frame: 4 hours post-treatment

  3. Clinical post-operative pain

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

    Time frame: 24 hours post treatment

  4. Clinical post-operative pain

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

    Time frame: 48 hours post treatment

  5. Clinical signs or symptoms of periapical disease

    Absence/presence of clinical signs or symptoms of periapical disease

    Time frame: 1 year

  6. Clinical signs or symptoms of periapical disease

    Absence/presence of clinical signs or symptoms of periapical disease

    Time frame: 2 years

  7. Clinical signs or symptoms of periapical disease

    Absence/presence of clinical signs or symptoms of periapical disease

    Time frame: 4 years

  8. Clinical signs or symptoms of periapical disease

    Absence/presence of clinical signs or symptoms of periapical disease

    Time frame: 6 years

  9. Radiographic periapical healing

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

    Time frame: 1 year

  10. Radiographic periapical healing

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

    Time frame: 2 years

  11. Radiographic periapical healing

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

    Time frame: 4 years

  12. Radiographic periapical healing

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

    Time frame: 6 years

Secondary outcomes

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

    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

    Time frame: 1 year

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

    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

    Time frame: 2 years

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

    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

    Time frame: 4 years

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

    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

    Time frame: 6 years

  5. Correlation of prognostic factors and radiographic periapical healing

    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

    Time frame: 1 year

  6. Correlation of prognostic factors and radiographic periapical healing

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

    Time frame: 2 years

  7. Correlation of prognostic factors and radiographic periapical healing

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

    Time frame: 4 years

  8. Correlation of prognostic factors and radiographic periapical healing

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

    Time frame: 6 years

07

Study locations

1 of 1 sites recruiting
  • Universitat Internacional de Catalunya
    Sant Cugat Del Vallès, Barcelona 08195, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04528979
Lead sponsor
Juan Gonzalo Olivieri
Responsible party
Juan Gonzalo Olivieri (Principal investigator, Universitat Internacional de Catalunya) — Sponsor-investigator
First posted
Aug 27, 2020
Start date
Sep 20, 2019
Primary completion
Jan 2021 (estimated)
Completion
Jan 2027 (estimated)
Last update
Aug 31, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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