Root Canal InfectionNCT04399720
Root Canal Treatment Outcome in Patients Under Bisphosphonate Therapy
An observational study of Root Canal Infection and Bisphosphonate-Associated Osteonecrosis, run by University of Bologna.
Trial summary
The aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Root Canal Infection, Bisphosphonate-Associated Osteonecrosis, Periapical Abscess
- What is being tested?
- Root canal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2009to 15 Dec 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 40 to 85 years
- All sexes
- Adult, Older adult
Study population: Similar geographic provenience
Who may be able to join
- Patients affected by endodontic disease and able to attend a hygiene recall program
Who cannot join
- inability to attend a recall hygien program
About this study
Official title: Root Canal Treatment of Compromised Teeth as Alternative Treatment in Patients Under Bisphosphonate Therapy: 60-month Results of a Prospective Clinical Study
The aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded.
Read the detailed description
The study was conducted in one University Endodontic Clinical Department - Dental School between January 2009 and December 2017.
Root canal treatment was performed according previously reported operative protocols.
- Conditions
- Root Canal Infection, Bisphosphonate-Associated Osteonecrosis, Periapical Abscess, Endodontically Treated Teeth
- Being tested
- Root canal treatment
- Keywords
- success rate, survival rate, endodontic treatment
- Medical subject headings
- Bisphosphonate-Associated Osteonecrosis of the Jaw, Periapical Abscess, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatmentProcedure or surgery
Root canal treatment using a standard manual k file instrumentation and carrier-based root canal filling technique
| Study group | Role | What they receive |
|---|---|---|
| BPS group | patients under Bisphosphonate therapy for at least 24 months Receives: Procedure: Root canal treatment | |
| healthy patients | healthy patients not assuming with no previous Bisphosphonate assumption Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
health patients
assessment of periapical index (PAI)
Measured: 5 years
Secondary outcomes (1)
Complications
extraction periapical re exacerbation during before the endline ( 5 years)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start7 Jan 2009
- Primary completion15 Dec 2016
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Root Canal InfectionStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fausto Zamparini, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399720
- Sponsor's protocol ID
- bifosfonendo
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pirani C, Chersoni S, Montebugnoli L, Prati C. Long-term outcome of non-surgical root canal treatment: a retrospective analysis. Odontology. 2015 May;103(2):185-93. doi: 10.1007/s10266-014-0159-0. Epub 2014 Jun 8.
PubMed 24908421Prati C, Pirani C, Zamparini F, Gatto MR, Gandolfi MG. A 20-year historical prospective cohort study of root canal treatments. A Multilevel analysis. Int Endod J. 2018 Sep;51(9):955-968. doi: 10.1111/iej.12908. Epub 2018 Mar 7.
PubMed 29432651
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Canal Treatment of Compromised Teeth as Alternative Treatment in Patients Under Bisphosphonate Therapy: 60-month Results of a Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04399720
- Acronym / sponsor ID
- bifosfonendo
- Conditions
- Root Canal Infection, Bisphosphonate-Associated Osteonecrosis, Periapical Abscess, Endodontically Treated Teeth
- Keywords
- success rate, survival rate, endodontic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 7 Jan 2009 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 22 May 2020 (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 this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded.
Detailed description
The study was conducted in one University Endodontic Clinical Department - Dental School between January 2009 and December 2017.
Root canal treatment was performed according previously reported operative protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPS group | – | Procedure: Root canal treatmentpatients under Bisphosphonate therapy for at least 24 months |
| healthy patients | – | Procedure: Root canal treatmenthealthy patients not assuming with no previous Bisphosphonate assumption |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- 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 hygiene recall program
Key exclusion criteria (1 listed)
- 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 treatmentRoot canal treatment using a standard manual k file instrumentation and carrier-based root canal filling technique | Procedure or surgery | BPS group, healthy patients |
Primary outcome
health patients
Time frame: 5 years
assessment of periapical index (PAI)
1 secondary outcome
Complications
Time frame: 5 years
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 27 May 2020.
- Results publication: PubMed 24908421Pirani C, Chersoni S, Montebugnoli L, Prati C. Long-term outcome of non-surgical root canal treatment: a retrospective analysis. Odontology. 2015 May;103(2):185-93. doi: 10.1007/s10266-014-0159-0. Epub 2014 Jun 8.
- Results publication: PubMed 29432651Prati C, Pirani C, Zamparini F, Gatto MR, Gandolfi MG. A 20-year historical prospective cohort study of root canal treatments. A Multilevel analysis. Int Endod J. 2018 Sep;51(9):955-968. doi: 10.1111/iej.12908. Epub 2018 Mar 7.
- 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 Infection and Bisphosphonate-Associated Osteonecrosis, 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 27 May 2020. 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: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399720, which also lists 2 linked publications.
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 27 May 2020.