NCT04528979

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Sep 2019Jan 2027

Study Start

First participant enrolled

September 20, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

May 21, 2020

Last Update Submit

August 27, 2020

Conditions

Endodontic DiseaseEndodontically Treated Teeth

Keywords

Primary root canal treatmentSecondary root canal treatmentOutcomeRoot canal sealer

Outcome Measures

Primary Outcomes (12)

  • Clinical post-operative pain

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

    Immediately post-treatment.

  • Clinical post-operative pain

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

    4 hours post-treatment

  • Clinical post-operative pain

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

    24 hours post treatment

  • Clinical post-operative pain

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

    48 hours post treatment

  • Clinical signs or symptoms of periapical disease

    Absence/presence of clinical signs or symptoms of periapical disease

    1 year

  • Clinical signs or symptoms of periapical disease

    Absence/presence of clinical signs or symptoms of periapical disease

    2 years

  • Clinical signs or symptoms of periapical disease

    Absence/presence of clinical signs or symptoms of periapical disease

    4 years

  • Clinical signs or symptoms of periapical disease

    Absence/presence of clinical signs or symptoms of periapical disease

    6 years

  • Radiographic periapical healing

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

    1 year

  • Radiographic periapical healing

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

    2 years

  • Radiographic periapical healing

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

    4 years

  • Radiographic periapical healing

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

    6 years

Secondary Outcomes (8)

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

    1 year

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

    2 years

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

    4 years

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

    6 years

  • Correlation of prognostic factors and radiographic periapical healing

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Primary root canal treatment

EXPERIMENTAL

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

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

Secondary root canal treatment

EXPERIMENTAL

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

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

Interventions

BioRoot RCS® root canal sealerOTHER

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

Primary root canal treatmentSecondary root canal treatment
AH Plus® root canal sealerOTHER

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

Primary root canal treatmentSecondary root canal treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.
  • Diagnosis of irreversible pulpitis or apical symptomatic / asymptomatic periodontitis.
  • Retreatment cases due to an endodontic failure.
  • 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 primary or secondary root canal treatment is not the treatment of choice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Dental Pulp DiseasesTooth, Nonvital

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic 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
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 21, 2020

First Posted

August 27, 2020

Study Start

September 20, 2019

Primary Completion

January 1, 2021

Study Completion (Estimated)

January 1, 2027

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)