Apical PeriodontitisNCT05221450
Factors Affecting the Endodontic Treatment Outcome
An observational study of Apical Periodontitis and Apical Granuloma, run by Odontos, Specialisticna Zobna Ambulanta, d.o.o. at 1 site in Slovenia.
Trial summary
The aim of this prospective cohort observational study is: (i) to assess the endodontic treatment outcome in a private specialist endodontic office in Slovenia; (ii) to estimate the effect of various pre-, intra- and postoperative factors onto endodontic treatment outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Periodontitis, Apical Granuloma, Apical Cyst
- What is being tested?
- primary endodontic treatment
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2008to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample population will include patients who are referred from a general dental practices in Slovenia to a private specialist endodontic practice for endodontic treatment, from the beginning of January 2008 on. All patients will be over 18 years of age at the beginning of the endodontic treatment and will attent a follow-up examination at least 1-4 years after endodontic treatment. Teeth will not be included in the study if (i) they have preoperative advanced periodontal disease, (ii) prior microsurgical root-end resection was performed, or (iii) the apex / apices of the tooth are not clearly discernible on any of the periapical radiographs. Teeth will be excluded from the study if (i) they will be extracted for non-endodontic reason or (ii) the patient will not attend a follow-up examination.
Who may be able to join
- patients referred to the private endodontic specialist office for endodontic treatment
- written informed consent was obtained prior beginning of the treatment.
Who cannot join
- preoperative advanced periodontal disease
- prior microsurgical root-end resection performed
- apices of the tooth were not clearly discernible on any of periapical radiographs
- endodontic treated teeth were extracted for non-endodontic reason
- the patient did not attend a follow-up examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Janja Jan, Prof. contact
Slovenia1 site, 1 recruiting
- Recruiting
Odontos, specialistična zobna ambulanta, d.o.o.
Ljubljana, 1000
Rok Juric, DMD, +386 1 2323231, rok.juric@odontos.si
Janja Jan, Prof., +386 1 5222770
About this study
The aim of this prospective cohort observational study is: (i) to assess the endodontic treatment outcome in a private specialist endodontic office in Slovenia; (ii) to estimate the effect of various pre-, intra- and postoperative factors onto endodontic treatment outcome.
- Conditions
- Apical Periodontitis, Apical Granuloma, Apical Cyst
- Being tested
- primary endodontic treatment
- Keywords
- root canal treatment, outcome, success
- Medical subject headings
- Periapical Periodontitis, Periapical Granuloma, Radicular Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary endodontic treatmentProcedure or surgery
Also called secondary endodontic treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment outcome based on strict combined radiographic and clinical criteria
Successful treatment outcome is defined as an absence of radiographic sign of apical periodontitis (periapical index PAI <= 2) and clinical signs of inflamation (swelling, sinus tract, tenderness to periapical palpation and percussion, pain) on follow-up examination 1-4 years postoperatively
Measured: 1-4 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jan 2008
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odontos, Specialisticna Zobna Ambulanta, d.o.o.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221450
- Sponsor's protocol ID
- 0120-402/2019/5
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anonymised IPD that uderlie the results in the publication will we shared to other researcher on reasonable request
Publications
Ng YL, Mann V, Gulabivala K. A prospective study of the factors affecting outcomes of nonsurgical root canal treatment: part 1: periapical health. Int Endod J. 2011 Jul;44(7):583-609. doi: 10.1111/j.1365-2591.2011.01872.x. Epub 2011 Mar 2.
PubMed 21366626Friedman S, Abitbol S, Lawrence HP. Treatment outcome in endodontics: the Toronto Study. Phase 1: initial treatment. J Endod. 2003 Dec;29(12):787-93. doi: 10.1097/00004770-200312000-00001.
PubMed 14686806European Society of Endodontology. Quality guidelines for endodontic treatment: consensus report of the European Society of Endodontology. Int Endod J. 2006 Dec;39(12):921-30. doi: 10.1111/j.1365-2591.2006.01180.x.
PubMed 17180780Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature - part 1. Effects of study characteristics on probability of success. Int Endod J. 2007 Dec;40(12):921-39. doi: 10.1111/j.1365-2591.2007.01322.x. Epub 2007 Oct 10.
PubMed 17931389Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10.
PubMed 17931388Ricucci D, Russo J, Rutberg M, Burleson JA, Spangberg LS. A prospective cohort study of endodontic treatments of 1,369 root canals: results after 5 years. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):825-42. doi: 10.1016/j.tripleo.2011.08.003.
PubMed 22099859
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Endodontic Treatment Outcome
- ClinicalTrials.gov ID
- NCT05221450
- Acronym / sponsor ID
- 0120-402/2019/5
- Conditions
- Apical Periodontitis, Apical Granuloma, Apical Cyst
- Keywords
- root canal treatment, outcome, success
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Odontos, Specialisticna Zobna Ambulanta, d.o.o.University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Feb 2022 (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 prospective cohort observational study is: (i) to assess the endodontic treatment outcome in a private specialist endodontic office in Slovenia; (ii) to estimate the effect of various pre-, intra- and postoperative factors onto endodontic treatment outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample population will include patients who are referred from a general dental practices in Slovenia to a private specialist endodontic practice for endodontic treatment, from the beginning of January 2008 on. All patients will be over 18 years of age at the beginning of the endodontic treatment and will attent a follow-up examination at least 1-4 years after endodontic treatment. Teeth will not be included in the study if (i) they have preoperative advanced periodontal disease, (ii) prior microsurgical root-end resection was performed, or (iii) the apex / apices of the tooth are not clearly discernible on any of the periapical radiographs. Teeth will be excluded from the study if (i) they will be extracted for non-endodontic reason or (ii) the patient will not attend a follow-up examination.
Key inclusion criteria (2 listed)
- patients referred to the private endodontic specialist office for endodontic treatment
- written informed consent was obtained prior beginning of the treatment.
Key exclusion criteria (5 listed)
- preoperative advanced periodontal disease
- prior microsurgical root-end resection performed
- apices of the tooth were not clearly discernible on any of periapical radiographs
- endodontic treated teeth were extracted for non-endodontic reason
- the patient did not attend a follow-up examination.
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 |
|---|---|---|
| primary endodontic treatmentAlso: secondary endodontic treatment | Procedure or surgery | – |
Primary outcome
Treatment outcome based on strict combined radiographic and clinical criteria
Time frame: 1-4 years postoperatively
Successful treatment outcome is defined as an absence of radiographic sign of apical periodontitis (periapical index PAI <= 2) and clinical signs of inflamation (swelling, sinus tract, tenderness to periapical palpation and percussion, pain) on follow-up examination 1-4 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Background: PubMed 21366626Ng YL, Mann V, Gulabivala K. A prospective study of the factors affecting outcomes of nonsurgical root canal treatment: part 1: periapical health. Int Endod J. 2011 Jul;44(7):583-609. doi: 10.1111/j.1365-2591.2011.01872.x. Epub 2011 Mar 2.
- Background: PubMed 14686806Friedman S, Abitbol S, Lawrence HP. Treatment outcome in endodontics: the Toronto Study. Phase 1: initial treatment. J Endod. 2003 Dec;29(12):787-93. doi: 10.1097/00004770-200312000-00001.
- Background: PubMed 17180780European Society of Endodontology. Quality guidelines for endodontic treatment: consensus report of the European Society of Endodontology. Int Endod J. 2006 Dec;39(12):921-30. doi: 10.1111/j.1365-2591.2006.01180.x.
- Background: PubMed 17931389Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature - part 1. Effects of study characteristics on probability of success. Int Endod J. 2007 Dec;40(12):921-39. doi: 10.1111/j.1365-2591.2007.01322.x. Epub 2007 Oct 10.
- Background: PubMed 17931388Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10.
- Background: PubMed 22099859Ricucci D, Russo J, Rutberg M, Burleson JA, Spangberg LS. A prospective cohort study of endodontic treatments of 1,369 root canals: results after 5 years. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):825-42. doi: 10.1016/j.tripleo.2011.08.003.
- Individual participant dataSharing planned: Yes. anonymised IPD that uderlie the results in the publication will we shared to other researcher on reasonable request
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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.
Janja Jan, Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Periodontitis and Apical Granuloma, run by Odontos, Specialisticna Zobna Ambulanta, d.o.o. at 1 site in Slovenia.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rok Juric, DMD (+386 1 2323231, rok.juric@odontos.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment outcome based on strict combined radiographic and clinical criteria (time frame: 1-4 years postoperatively). 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 NCT05221450, which also lists 6 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 9 Apr 2024.