Root Canal TreatmentENDOBO20NCT03215225
Endodontic Root-canal Treatments Evaluated After Long-term Time
An observational study of Root Canal Treatment and Endodontic Disease, run by University of Bologna.
Trial summary
The aim of the study was to evaluate the root canal treatments performed from 1989 to 1995. Type of complication, success, new endodontic diseases and number of success were reported. Mean clinical parameters were clinical symptoms and presence/absence of apical radiolucency. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Treatment, Endodontic Disease
- What is being tested?
- Root canal orthograde treatment
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 1989to 2 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Similar geographic provenience
Who may be able to join
- Patients affected by endodontic disease and able to attend a recall hygien program
Who cannot join
- Sistemic disease Cancer Inability to attend a recall hygien program
About this study
Official title: Long-term Evaluation of Endodontic Root Canal Treatments: Complication, Factors Affecting Failure, New Disease and Success
The aim of the study was to evaluate the root canal treatments performed from 1989 to 1995. Type of complication, success, new endodontic diseases and number of success were reported. Mean clinical parameters were clinical symptoms and presence/absence of apical radiolucency.
Read the detailed description
See previous papers (Pirani et al., Odontology, 2015)
- Conditions
- Root Canal Treatment, Endodontic Disease
- Being tested
- Root canal orthograde treatment
- Keywords
- Endodontology, Endodontics
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal orthograde treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment | Not described Receives: Procedure: Root canal orthograde treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Patients
patients with periapical disease and/or pulpal disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Dec 1989
- Primary completion20 Dec 2016
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Prati, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215225
- Sponsor's protocol ID
- Endo master treatment
- Acronym
- ENDOBO20
- Status last verified
- Jul 2017
- First submitted
- 9 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of Endodontic Root Canal Treatments: Complication, Factors Affecting Failure, New Disease and Success
- ClinicalTrials.gov ID
- NCT03215225
- Acronym / sponsor ID
- ENDOBO20 / Endo master treatment
- Conditions
- Root Canal Treatment, Endodontic Disease
- Keywords
- Endodontology, Endodontics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Dec 1989 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to evaluate the root canal treatments performed from 1989 to 1995. Type of complication, success, new endodontic diseases and number of success were reported. Mean clinical parameters were clinical symptoms and presence/absence of apical radiolucency.
Detailed description
See previous papers (Pirani et al., Odontology, 2015)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment | – | Procedure: Root canal orthograde treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Similar geographic provenience
Key inclusion criteria (1 listed)
- Patients affected by endodontic disease and able to attend a recall hygien program
Key exclusion criteria (1 listed)
- Sistemic disease Cancer Inability to attend a recall hygien program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root canal orthograde treatment | Procedure or surgery | Root canal treatment |
Primary outcome
Health Patients
Time frame: 2 years
patients with periapical disease and/or pulpal disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Root Canal Treatment and Endodontic Disease, run by University of Bologna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.