Periapical PeriodontitisNCT04495270
2-year Treatment Outcomes of Teeth Estimated by Means of Periapical and Endodontic Status Scale
An observational study of Periapical Periodontitis and Treatment Outcome, run by Lithuanian University of Health Sciences.
Trial summary
Objectives: Evaluation of endodontic treatment success is largely based on radiographical assessment of anatomical and treatment-related parameters of teeth with apical periodontitis (AP). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis, Treatment Outcome
- What is being tested?
- Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale"
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2016to 20 Dec 2019
- How long will I take part?
- 2 Years
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study participants were adult patients, admitted for general oral rehabilitation and referred for treatment to a specialist in endodontics
Who may be able to join
- no systemic diseases present;
- at least one tooth with the diagnosis of AP (necrotic pulp and/or filled root canals) present;
- sufficient periodontal support (absence of clinical periodontal inflammation on an anatomically intact or, on a reduced periodontium [13] of the teeth indicated for treatment);
- baseline CBCT images available (performed for general oral rehabilitation planning purposes, no earlier than one month prior to endodontic procedures).
Who cannot join
- Pregnant women;
- immunosuppressed patient
- patients presenting with un-restorable teeth (e.g., deep root caries lesion, coronal cracks, root fracture)
- with the probing depths >5 mm around the marginal bone.
About this study
Official title: Two-year Treatment Outcomes of Teeth With Apical Periodontitis Based on Cone-beam Computed Tomography and Estimated by Means of Periapical and Endodontic Status Scale
Objectives: Evaluation of endodontic treatment success is largely based on radiographical assessment of anatomical and treatment-related parameters of teeth with apical periodontitis (AP). This study aimed to analyse 2-year treatment outcomes of teeth with AP based on radiographical changes, and to evaluate prognostic validity of Periapical and Endodontic Status Scale (PESS).
Materials and Methods: 128 patients (176 teeth) were examined by cone-beam computed tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was evaluated using estimates of periapical radiolucencies in size, relation with anatomical structures and location. Strength of associations between these and treatment-related parameters was tested by logistic regression analysis. Predictive validity of PESS was verified by estimating association between treatment risk groups defined at baseline and negative outcome.
Read the detailed description
Study sample The study participants were adult patients, admitted for general oral rehabilitation to Vilnius Implantology Center, Lithuania, and referred for treatment to a specialist in endodontics during the period December 2016 - December 2019. A total of 140 patients, with 200 teeth with AP, were invited to participate in the study. Ten patients were excluded according to the inclusion criteria, and 2 patients declined to participate. Finally, 128 patients with 176 teeth with AP, agreed to participate in this study. The mean age of the participants was 46 years, range 18-70 years, (SD =12.3).
The inclusion criteria were as follows:
- no systemic diseases present;
- at least one tooth with the diagnosis of AP (necrotic pulp and/or filled root canals) present;
- sufficient periodontal support (absence of clinical periodontal inflammation on an anatomically intact or, on a reduced periodontium of the teeth indicated for treatment);
- baseline CBCT images available (performed for general oral rehabilitation planning purposes, no earlier than one month prior to endodontic procedures).
The diagnosis of apical periodontitis was based on the clinical tests of pulp vitality (sensitivity to heat and cold), percussion, palpation, presence of abnormal bite, swelling, caries, sinus tracts, of unstimulated/stimulated pain, and on the radiological findings. A total of 176 teeth (403 root canals) were subjected to endodontic treatment.
Pregnant women, immunosuppressed patients, and patients presenting with un-restorable teeth (e.g., deep root caries lesion, coronal cracks, root fracture) or, with the probing depths >5 mm around the marginal bone were excluded.
All the participants gave written informed consent to be involved in the clinical trial. The study protocol was approved by the Ethical Committee of Biomedical studies, Lithuania (Protocol No 111; 10.03.2016; edition No BE-2-27; 20.12.2016).
Clinical and radiographic examinations:
All study patients were examined clinically and radiographically at baseline, and in 24 months (further on, referred as "2 years") after endodontic treatment. The intermediate follow-up examinations were set at 12 months' time point, however, only the final study results are discussed in the present report.
The clinical examinations were performed by one examiner (JG) and included standard tests such as percussion, palpation, evaluation of coronal seal, of tooth mobility and of the periodontal probing depth. All diagnostic procedures were performed in a dental chair using a dental mirror and explorer (Dentsply Maillefer, Ballaigues, Switzerland). The case history (presence of clinical symptoms, complaints, the time of the previous treatment) was obtained from every patient.
Radiographical examinations of the patients were performed with CBCT imaging, and with digital radiography. For the present study purposes, only CBCT data were included in the analysis. The baseline CBCT images were already available following the general diagnostic and treatment plan. The follow-up CBCT was performed in 2 years after the endodontic treatment, only for the respective maxillary or mandibular arch. All images were made with i-CAT scanner (Imaging Sciences International Inc., Hatfield, PA, USA), the exposure parameters were as follows: 84 kV, 5 mA, 0.3 mm voxel resolution, 6x16 and 6x6 cm field of view, 18.3s and 5s acquisition time at baseline and at the final examination, respectively. The CBCT images were viewed as an original i-Cat presentation (Apple, Cupertino, CA, USA) on the computers with a 27-inch flat panel display with a pixel resolution of 2.560 x 1.440 with dimmed ambient light, less than 50 lux, without time restrictions. A total of 256 (128 baseline and 128 follow up) CBCT images were coded and analyzed by the same examiner (JG), without knowledge of the clinical data.
The radiographical assessment of the periapical status of the teeth was performed following the Periapical and Endodontic Status Scale (PESS).
- Conditions
- Periapical Periodontitis, Treatment Outcome
- Being tested
- Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale"
- Keywords
- Cone-beam computed tomography, Periapical periodontitis, Scale, Treatment outcome
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale"Diagnostic test
Patients were examined by cone-beam computed tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was evaluated using estimates of periapical radiolucencies in size, relation with anatomical structures and location.
| Study group | Role | What they receive |
|---|---|---|
| Clinical observation | All study patients were examined by 1 endodontist clinically and radiographically at baseline and after follow up of endodontic treatment. Receives: Diagnostic Test: Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale" |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive treatment outcome
Decreased periapical radiolucency, with respect to it's size, or/and relation with anatomical structures, location (respective parameters S, R, and D). Moreover, the unchanged mild severity scores S1, D1, and R1 were regarded as positive outcome as well. The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).
Measured: 24 months
The negative treatment outcome
Increased/unchanged periapical radiolucency in size, or/and in relation with anatomical structures, or/and in location (respective parameters S, R, and D). By comparing the baseline and the final CBCT images all transition events from the lower to the higher scores and the following unchanged scores were considered as negative treatment outcomes.The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start20 Dec 2016
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical 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
- 128 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jelena Gudac, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495270
- Sponsor's protocol ID
- BE-2-27
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-year Treatment Outcomes of Teeth With Apical Periodontitis Based on Cone-beam Computed Tomography and Estimated by Means of Periapical and Endodontic Status Scale
- ClinicalTrials.gov ID
- NCT04495270
- Acronym / sponsor ID
- BE-2-27
- Conditions
- Periapical Periodontitis, Treatment Outcome
- Keywords
- Cone-beam computed tomography, Periapical periodontitis, Scale, Treatment outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 31 Jul 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.
Objectives: Evaluation of endodontic treatment success is largely based on radiographical assessment of anatomical and treatment-related parameters of teeth with apical periodontitis (AP). This study aimed to analyse 2-year treatment outcomes of teeth with AP based on radiographical changes, and to evaluate prognostic validity of Periapical and Endodontic Status Scale (PESS).
Materials and Methods: 128 patients (176 teeth) were examined by cone-beam computed tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was evaluated using estimates of periapical radiolucencies in size, relation with anatomical structures and location. Strength of associations between these and treatment-related parameters was tested by logistic regression analysis. Predictive validity of PESS was verified by estimating association between treatment risk groups defined at baseline and negative outcome.
Detailed description
Study sample The study participants were adult patients, admitted for general oral rehabilitation to Vilnius Implantology Center, Lithuania, and referred for treatment to a specialist in endodontics during the period December 2016 - December 2019. A total of 140 patients, with 200 teeth with AP, were invited to participate in the study. Ten patients were excluded according to the inclusion criteria, and 2 patients declined to participate. Finally, 128 patients with 176 teeth with AP, agreed to participate in this study. The mean age of the participants was 46 years, range 18-70 years, (SD =12.3).
The inclusion criteria were as follows:
- no systemic diseases present;
- at least one tooth with the diagnosis of AP (necrotic pulp and/or filled root canals) present;
- sufficient periodontal support (absence of clinical periodontal inflammation on an anatomically intact or, on a reduced periodontium of the teeth indicated for treatment);
- baseline CBCT images available (performed for general oral rehabilitation planning purposes, no earlier than one month prior to endodontic procedures).
The diagnosis of apical periodontitis was based on the clinical tests of pulp vitality (sensitivity to heat and cold), percussion, palpation, presence of abnormal bite, swelling, caries, sinus tracts, of unstimulated/stimulated pain, and on the radiological findings. A total of 176 teeth (403 root canals) were subjected to endodontic treatment.
Pregnant women, immunosuppressed patients, and patients presenting with un-restorable teeth (e.g., deep root caries lesion, coronal cracks, root fracture) or, with the probing depths >5 mm around the marginal bone were excluded.
All the participants gave written informed consent to be involved in the clinical trial. The study protocol was approved by the Ethical Committee of Biomedical studies, Lithuania (Protocol No 111; 10.03.2016; edition No BE-2-27; 20.12.2016).
Clinical and radiographic examinations:
All study patients were examined clinically and radiographically at baseline, and in 24 months (further on, referred as "2 years") after endodontic treatment. The intermediate follow-up examinations were set at 12 months' time point, however, only the final study results are discussed in the present report.
The clinical examinations were performed by one examiner (JG) and included standard tests such as percussion, palpation, evaluation of coronal seal, of tooth mobility and of the periodontal probing depth. All diagnostic procedures were performed in a dental chair using a dental mirror and explorer (Dentsply Maillefer, Ballaigues, Switzerland). The case history (presence of clinical symptoms, complaints, the time of the previous treatment) was obtained from every patient.
Radiographical examinations of the patients were performed with CBCT imaging, and with digital radiography. For the present study purposes, only CBCT data were included in the analysis. The baseline CBCT images were already available following the general diagnostic and treatment plan. The follow-up CBCT was performed in 2 years after the endodontic treatment, only for the respective maxillary or mandibular arch. All images were made with i-CAT scanner (Imaging Sciences International Inc., Hatfield, PA, USA), the exposure parameters were as follows: 84 kV, 5 mA, 0.3 mm voxel resolution, 6x16 and 6x6 cm field of view, 18.3s and 5s acquisition time at baseline and at the final examination, respectively. The CBCT images were viewed as an original i-Cat presentation (Apple, Cupertino, CA, USA) on the computers with a 27-inch flat panel display with a pixel resolution of 2.560 x 1.440 with dimmed ambient light, less than 50 lux, without time restrictions. A total of 256 (128 baseline and 128 follow up) CBCT images were coded and analyzed by the same examiner (JG), without knowledge of the clinical data.
The radiographical assessment of the periapical status of the teeth was performed following the Periapical and Endodontic Status Scale (PESS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical observation | – | Diagnostic Test: Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale"All study patients were examined by 1 endodontist clinically and radiographically at baseline and after follow up of endodontic treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study participants were adult patients, admitted for general oral rehabilitation and referred for treatment to a specialist in endodontics
Key inclusion criteria (4 listed)
- no systemic diseases present;
- at least one tooth with the diagnosis of AP (necrotic pulp and/or filled root canals) present;
- sufficient periodontal support (absence of clinical periodontal inflammation on an anatomically intact or, on a reduced periodontium [13] of the teeth indicated for treatment);
- baseline CBCT images available (performed for general oral rehabilitation planning purposes, no earlier than one month prior to endodontic procedures).
Key exclusion criteria (4 listed)
- Pregnant women;
- immunosuppressed patient
- patients presenting with un-restorable teeth (e.g., deep root caries lesion, coronal cracks, root fracture)
- with the probing depths >5 mm around the marginal bone.
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 |
|---|---|---|
| Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale"Patients were examined by cone-beam computed tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was evaluated using estimates of periapical radiolucencies in size, relation with anatomical structures and location. | Diagnostic test | Clinical observation |
Primary outcome
The positive treatment outcome
Time frame: 24 months
Decreased periapical radiolucency, with respect to it's size, or/and relation with anatomical structures, location (respective parameters S, R, and D). Moreover, the unchanged mild severity scores S1, D1, and R1 were regarded as positive outcome as well. The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).
The negative treatment outcome
Time frame: 24 months
Increased/unchanged periapical radiolucency in size, or/and in relation with anatomical structures, or/and in location (respective parameters S, R, and D). By comparing the baseline and the final CBCT images all transition events from the lower to the higher scores and the following unchanged scores were considered as negative treatment outcomes.The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).
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 31 Jul 2020.
- 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 Periapical Periodontitis and Treatment Outcome, run by Lithuanian University of Health Sciences.
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 4 inclusion and 4 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 31 Jul 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?
The positive treatment outcome (time frame: 24 months). The study lists 2 primary outcomes in all. 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 31 Jul 2020.