Apical PeriodontitisNCT06629545
The Efficacy of Two Different Irrigation Methods on PGE2, NO and IL-6 Levels
A study testing irrigation activation with PUI and irrigation with sonic activation in people with Apical Periodontitis and Inflammatory Markers, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Today, debates about the effectiveness of Passive Ultrasonic Irrigation (PUI) and Sonically Activated Irrigation (SAI) techniques used to increase the success of endodontic treatment in chronic apical periodontitis (AP) are still ongoing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Inflammatory Markers
- What is being tested?
- irrigation activation with PUI and irrigation with sonic activation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2023to 1 Apr 2024
- Phase
- Interventional
- 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
Who may be able to join
- For control group
- People who come for a check-up, are healthy in terms of dental and periodontal health, do not have any systemic acute or chronic disease (such as infection, kidney disease, cardiovascular disease, inflammatory and rheumatic disease, diabetes and local or widespread tissue damage) and have similar values in terms of gender, age and weight to the study groups, For experimental groups
- Being systemically healthy,
- Patients between the ages of 18-65,
- Those having a PAI score of 3-5 For both study and control groups
- The volunteer wishes to participate in the research by signing the \'Informed Consent Form\'.
Who cannot join
- Those who have used nonsteroidal anti-inflammatory drugs and/or immunosuppressive drugs, steroids in the last 48 hours as this may affect the test results, and those who have a history of using high doses of biotin vitamin as this may affect the test results,
- Those who were either pregnant, lactating, morbidly obese, presence of malignancy, presence of concomitant infection other than AP, presence of acute or chronic inflammatory disease,
- Those with periodontal disease (with periodontal pockets and attachment levels exceeding 4 mm.),
- Those having inadequate crown structures for isolation with a rubber dam,
- Those with a history of previous endodontic treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Faculty of Dentistry
Istanbul, Esenler
About this study
Official title: Comparison of Passive Ultrasonic and Sonically Activated Irrigation Methods in the Treatment of Apical Periodontitis: Evaluation of PGE2, NO and IL-6 Levels
Today, debates about the effectiveness of Passive Ultrasonic Irrigation (PUI) and Sonically Activated Irrigation (SAI) techniques used to increase the success of endodontic treatment in chronic apical periodontitis (AP) are still ongoing.
In this study, the effectiveness of PUI and SAI systems was investigated in AP patients with similar infection burden and periapical lesion size (PLS) based on changes in prostaglandin E2 (PGE2), nitric oxide (NO) and interleukin-6 (IL-6) levels, which are important biomarkers of inflammatory response in gingival crevicular fluid (GCF) samples.
The study was planned as a single-center cross-sectional analytical study. A total of 60 patients with AP requiring root canal treatment [PUI (n:30) and SAI (n:30)] and 30 healthy controls were included in the study between January and June 2024. Demographic characteristics of the patients as well as clinical and radiographic findings (PLS and PAI score) were recorded. GCF (preGCF), PGE2, NO and IL-6 levels were measured in all participants before irrigation. The same procedure was repeated in GCF samples 1 week after treatment (postGCF), except for the control group. In addition, 1st order most commonly seen bacteria (FMCB) typing was performed on swab samples taken from the root canals of the patients.
Read the detailed description
The diagnosis was established according to the patient's history, clinical inspection including palpation, tenderness to percussion, pulpal sensitivity testing, and radiographic examination. Demographic characteristics of the participants (age, gender, chronic disease status, etc.) as well as clinical and radiographic findings [pain level, number of crowns (NC), number of fillings (NF), number of root canal fillings (NRC), and number of missing teeth (NMT)] were recorded. Panoramic and periapical dental radiographs were taken. The presence of radiolucent images associated with the periapical region and radiographic bone loss were evaluated. Radiographs were examined with the help of Kodak Dental Imaging Software. The presence of periapical radiolucency without periodontal disease was considered sufficient criteria for the diagnosis of AP. The largest diameter of the lesion was measured on preoperative periapical radiographs and recorded as periapical lesion size (PLS). In addition, periapical index (PAI) score defined by Ørstavik et al (Ørstavik et al., 1986) and abscess scoring based on the periapical index (AS-PAI) were recorded for patients with AP. AS-PAI was determined as follows: AS-PAI-0 if PAI<5, AS-PAI-1 if only 1 tooth with PAI 5 and AS-PAI-2 if >2 teeth with PAI 5
- Conditions
- Apical Periodontitis, Inflammatory Markers
- Being tested
- irrigation activation with PUI, irrigation with sonic activation
- Keywords
- apical periodontitis, passive ultrasonic irrigation, Sonically Activated Irrigation, Gingival crevicular fluid, PGE, IL-6
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irrigation activation with PUIOther
The irrigation solution was used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device. The power setting of the ultrasonic device was 30% (VDW Ultra; VDW, Munich, Germany). The tip was activated a total of three times, with each cycle lasting 20 s and involving the use of 1 ml of 2.5% NaOCl. Then, 2 ml of 17% EDTA solution was activated for 1 min as describe above. The ultrasonic tip was placed 1 mm behind the working length without touching the canal walls.
irrigation with sonic activationOther
A suitable-size activator tip (#25/.04) attached to an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA) was inserted into the canal 1 mm short of the working length. 3 ml of 2.5% NaOCl solution was activated in three periods of 20 s (1 ml of 2.5% NaOCl in each cycle). Then, the same procedure was repeated with 2 ml of 17% EDTA solution.
| Study group | Role | What they receive |
|---|---|---|
| Passive ultrasonic irrigation | Experimental | The irrigation solution was agitated by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device. Receives: Other: irrigation activation with PUI |
| Sonic activated irrigation | Experimental | The irrigation solution was agitated by a suitable-size activator tip (#25/.04) attached to an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). Receives: Other: irrigation with sonic activation |
| Control group | No intervention | Pre-treatment GCF (preGCF) samples were collected for all participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
ELISA Analysis of Biochemical Parameters
ELISA assay was performed to measure preGCF and postGCF-PGE2, NO and IL-6 levels
Measured: Up to 36 weeks
Secondary outcomes (1)
Genomic DNA isolation and measurement of DNA concentration
Pretreatment bacteria number and bacteria species of samples taken from root canals measured via PCR and Sanger sequencing
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start2 Aug 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda Ersahan, DDS, PhD, Istanbul Medipol University Hospital
- Investigators
- Seyda Ersahan, Assoc.Prof., Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629545
- Sponsor's protocol ID
- 2023
- Status last verified
- Jun 2024
- First submitted
- 1 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Passive Ultrasonic and Sonically Activated Irrigation Methods in the Treatment of Apical Periodontitis: Evaluation of PGE2, NO and IL-6 Levels
- ClinicalTrials.gov ID
- NCT06629545
- Acronym / sponsor ID
- 2023
- Conditions
- Apical Periodontitis, Inflammatory Markers
- Keywords
- apical periodontitis, passive ultrasonic irrigation, Sonically Activated Irrigation, Gingival crevicular fluid, PGE, IL-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 8 Oct 2024 (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.
Today, debates about the effectiveness of Passive Ultrasonic Irrigation (PUI) and Sonically Activated Irrigation (SAI) techniques used to increase the success of endodontic treatment in chronic apical periodontitis (AP) are still ongoing.
In this study, the effectiveness of PUI and SAI systems was investigated in AP patients with similar infection burden and periapical lesion size (PLS) based on changes in prostaglandin E2 (PGE2), nitric oxide (NO) and interleukin-6 (IL-6) levels, which are important biomarkers of inflammatory response in gingival crevicular fluid (GCF) samples.
The study was planned as a single-center cross-sectional analytical study. A total of 60 patients with AP requiring root canal treatment [PUI (n:30) and SAI (n:30)] and 30 healthy controls were included in the study between January and June 2024. Demographic characteristics of the patients as well as clinical and radiographic findings (PLS and PAI score) were recorded. GCF (preGCF), PGE2, NO and IL-6 levels were measured in all participants before irrigation. The same procedure was repeated in GCF samples 1 week after treatment (postGCF), except for the control group. In addition, 1st order most commonly seen bacteria (FMCB) typing was performed on swab samples taken from the root canals of the patients.
Detailed description
The diagnosis was established according to the patient's history, clinical inspection including palpation, tenderness to percussion, pulpal sensitivity testing, and radiographic examination. Demographic characteristics of the participants (age, gender, chronic disease status, etc.) as well as clinical and radiographic findings [pain level, number of crowns (NC), number of fillings (NF), number of root canal fillings (NRC), and number of missing teeth (NMT)] were recorded. Panoramic and periapical dental radiographs were taken. The presence of radiolucent images associated with the periapical region and radiographic bone loss were evaluated. Radiographs were examined with the help of Kodak Dental Imaging Software. The presence of periapical radiolucency without periodontal disease was considered sufficient criteria for the diagnosis of AP. The largest diameter of the lesion was measured on preoperative periapical radiographs and recorded as periapical lesion size (PLS). In addition, periapical index (PAI) score defined by Ørstavik et al (Ørstavik et al., 1986) and abscess scoring based on the periapical index (AS-PAI) were recorded for patients with AP. AS-PAI was determined as follows: AS-PAI-0 if PAI<5, AS-PAI-1 if only 1 tooth with PAI 5 and AS-PAI-2 if >2 teeth with PAI 5
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Passive ultrasonic irrigation | Experimental | Other: irrigation activation with PUIThe irrigation solution was agitated by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device. |
| Sonic activated irrigation | Experimental | Other: irrigation with sonic activationThe irrigation solution was agitated by a suitable-size activator tip (#25/.04) attached to an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). |
| Control group | No intervention | –Pre-treatment GCF (preGCF) samples were collected for all participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For control group
- People who come for a check-up, are healthy in terms of dental and periodontal health, do not have any systemic acute or chronic disease (such as infection, kidney disease, cardiovascular disease, inflammatory and rheumatic disease, diabetes and local or widespread tissue damage) and have similar values in terms of gender, age and weight to the study groups, For experimental groups
- Being systemically healthy,
- Patients between the ages of 18-65,
- Those having a PAI score of 3-5 For both study and control groups
Key exclusion criteria (5 listed)
- Those who have used nonsteroidal anti-inflammatory drugs and/or immunosuppressive drugs, steroids in the last 48 hours as this may affect the test results, and those who have a history of using high doses of biotin vitamin as this may affect the test results,
- Those who were either pregnant, lactating, morbidly obese, presence of malignancy, presence of concomitant infection other than AP, presence of acute or chronic inflammatory disease,
- Those with periodontal disease (with periodontal pockets and attachment levels exceeding 4 mm.),
- Those having inadequate crown structures for isolation with a rubber dam,
- Those with a history of previous endodontic treatment.
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 |
|---|---|---|
| irrigation activation with PUIThe irrigation solution was used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device. The power setting of the ultrasonic device was 30% (VDW Ultra; VDW, Munich, Germany). The tip was activated a total of three times, with each cycle lasting 20 s and involving the use of 1 ml of 2.5% NaOCl. Then, 2 ml of 17% EDTA solution was activated for 1 min as describe above. The ultrasonic tip was placed 1 mm behind the working length without touching the canal walls. | Other | Passive ultrasonic irrigation |
| irrigation with sonic activationA suitable-size activator tip (#25/.04) attached to an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA) was inserted into the canal 1 mm short of the working length. 3 ml of 2.5% NaOCl solution was activated in three periods of 20 s (1 ml of 2.5% NaOCl in each cycle). Then, the same procedure was repeated with 2 ml of 17% EDTA solution. | Other | Sonic activated irrigation |
Primary outcome
ELISA Analysis of Biochemical Parameters
Time frame: Up to 36 weeks
ELISA assay was performed to measure preGCF and postGCF-PGE2, NO and IL-6 levels
1 secondary outcome
Genomic DNA isolation and measurement of DNA concentration
Time frame: Up to 36 weeks
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 8 Oct 2024.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
Seyda Ersahan, Assoc.Prof. principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing irrigation activation with PUI and irrigation with sonic activation in people with Apical Periodontitis and Inflammatory Markers, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 8 Oct 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 Turkey (Türkiye). 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?
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?
ELISA Analysis of Biochemical Parameters (time frame: Up to 36 weeks). 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 8 Oct 2024.