RecruitingNot Applicable

Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

Spain220 participantsStarted 2019-09-20

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical post-operative pain

Timeframe: Immediately post-treatment.

Clinical post-operative pain

Timeframe: 4 hours post-treatment

Clinical post-operative pain

Timeframe: 24 hours post treatment

Clinical post-operative pain

Timeframe: 48 hours post treatment

Clinical signs or symptoms of periapical disease

Timeframe: 1 year

Clinical signs or symptoms of periapical disease

Timeframe: 2 years

Clinical signs or symptoms of periapical disease

Timeframe: 4 years

Clinical signs or symptoms of periapical disease

Trial details

NCT IDNCT04528979

SponsorJuan Gonzalo Olivieri

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01

View on ClinicalTrials.gov More Endodontic Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clinical post-operative pain

Timeframe: Immediately post-treatment.

Clinical post-operative pain

Timeframe: 4 hours post-treatment

Clinical post-operative pain

Timeframe: 24 hours post treatment

Clinical post-operative pain

Timeframe: 48 hours post treatment

Clinical signs or symptoms of periapical disease

Timeframe: 1 year

Clinical signs or symptoms of periapical disease

Timeframe: 2 years

Clinical signs or symptoms of periapical disease

Timeframe: 4 years

Clinical signs or symptoms of periapical disease