Irreversible PulpitisNCT05277246
Effect of Using Different Concentrations of NaOCI on IL-8 Level
A study testing Irrigant concentration and NaOCI in people with Irreversible Pulpitis, run by Yuzuncu Yil University.
Trial summary
The objective is to compare various concentrations of NAOCL during Root canal treatment and their effect on IL-8 at the gingival crevicular fluid. Despite the current advancement of beneficial endodontic diagnostic methods, such as pulp sensitivity tests and periapical radiographs, clinical outcomes do not always… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Irrigant concentration and NaOCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2022to 20 Jul 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Who cannot join
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Using Different Concentrations of NaOCI on IL-8 Level During Endodontic Treatment of Teeth With Irreversible Pulpitis
The objective is to compare various concentrations of NAOCL during Root canal treatment and their effect on IL-8 at the gingival crevicular fluid. Despite the current advancement of beneficial endodontic diagnostic methods, such as pulp sensitivity tests and periapical radiographs, clinical outcomes do not always correspond with the arrangement of the histological condition of the pulp. At this point, the need for other ways to help diagnose pathological pulpal disease has arisen. This situation has influenced researchers to use molecular evaluation as an alternative route in endodontic diagnosis. Biomarkers, functional at the cellular and molecular level, are crucial elements within the pathological process. Detection of molecular markers is considered an ancillary method for diagnosing the pathological condition of the pulp tissue.An increase in inflammatory cells in the carious or traumatized dentinal pulp complex has been reported. In the presence of bacteria, immune cells produce interleukin-6 (IL6), interleukin-8 (CXCL8), and tumor necrosis factor-alpha (TNF) in the pulp. Interleukin-8 is frequently expressed in endothelial cells of inflamed pulp and rarely in the normal pulp. Karapanou et al. (2008) revealed that interleukin-8 was more greatly released in teeth with irreversible pulpitis than in the control group in a research in which gingival crevicular fluid with acute pulpitis was analyzed. the pulp tissue and gingival crevicular fluid of teeth with symptomatic irreversible pulpitis were dramatically augmented by these indicators compared with healthy teeth. Furthermore, they concluded that the levels of NKA, SP, IL8, and MMP8 in the gingival crevicular fluid decreased one week after endodontic treatment of teeth with pulpitis. Subsequently, it has been reported that patients with symptomatic irreversible pulpitis with high initial pain scores have higher levels of SP, IL8, and MMP8 in the pulp tissue samples than those with low pain scores.It is recommended to use NaOCl concentration between 0.5% and 5.25% as an irrigation solution in root canal treatment (6). The effectiveness of NaOCl increases with increasing concentration, but its toxicity is known to be proportional to concentration.
Therefore, there is no consensus on the optimal concentration of NaOCL. When articles were reviewed, it was found that inflammation of the pulp and biomarker levels are correlated. For this reason, we believe that whether or not NaOCl solution at various concentrations causes inflammation can be analyzed by the level of IL-8. Upon review of the literature, it was found that no studies investigated the influence of NaOCl solution on biomarkers in the gingival crevicular fluid. The research described below contributes to the literature on the optimal concentration of NaOCl to use.
Read the detailed description
The study is to be carried out in 84 medically fit patients, aged 18-50 years, who were diagnosed and followed up at Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Endodontics, (The number of patients was determined according to "power analysis.") Lower first and second molars (36,37,46,47) diagnosed with irreversible pulpitis will be included in the study as an experimental group.
As the control group, the contralateral teeth of the related teeth will be evaluated. Patients with periapical lesions and open apex teeth will not be included in the study group. Before treatment, patients will be asked to determine their pain level according to a 0-10 VAS scale, and this value will be recorded for comparison with post-treatment. Teeth (experimental and control ) to be sampled from the gingival crevicular fluid will be isolated with a cotton roll and saliva ejector.
The supragingival plaque will be carefully removed using a curette. The teeth to be inspected will be dried with air for 10 seconds. A Periopaper strip (Oraflow, Smithtown, NY, USA) will be placed in the interproximal mesial gingival sulcus of the affected tooth until slight resistance is confronted and is removed after 1 min. Samples contaminated with blood or saliva will not be involved in the study. All collected periopaper strips will be placed in 1.5 ml Eppendorf tubes (Labosel, Istanbul, Turkey) and stored at -80 ° C until analysis.
After applying 2ml local anesthesia (Maxicaine DS strong (Vem, İstanbul, Türkiye)), the access cavity will be opened with diamond bur. The working length will be determined using the apex locator (DentsplyMaillefer, UK) and the radiographic x-ray by placing a K file #15 (Mani Inc, Tochigi, Japan) into the root canals until the apical constriction.
The shaping process of the root canals will be accomplished by ProTaperNext (DentsplyMaillefer, Baillagues, Switzerland) up to the X3 instrument as standard in each patient. The study will be randomly divided into 3 groups (n= ) according to the irrigation solution used during shaping (G1: 1% NaOCl; G2: 2.5% NaOCl; G3: 5.25% NaOCl). 2 ml of irrigation solution will be applied after each file.
A 2 ml dental injector with a 27 gauge dental needle will be used; the tip of the needle will be adjusted to reach two-thirds of the working length. For the final irrigation of the root canals that have completed the shaping process, 5 ml of 17% EDTA solution and NaOCl solution will be used, respectively. Later on, the canals will be dried with sterile paper points.
Root canals will be obturated with sterile gutta-perchas and AH+ (Dentsply De Trey, Konstanz, Germany) root canal sealer using the single cone technique.
Finally, the teeth will be restored using composite. One week after treatment, the patient will be called for a follow-up appointment.
The patients will be asked to determine the pain level according to the VAS scale, and it will be recorded. A specimen of gingival crevicular fluid will be taken from the root canal treated teeth in the same manner as at the commencement and stored. The amount of IL-8 in the gingival crevicular fluid will be measured with an enzyme-linked immunoassay (ELISA) kit (Cayman, Ann Arbor, MI).
- Conditions
- Irreversible Pulpitis
- Being tested
- Irrigant concentration, NaOCI
- Keywords
- Gingival cervicular fluidi, IL-8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigant concentrationOther
The success of endodontic treatment is directly related to infection control. In successful endodontic treatment, it is necessary to perform an ideal irrigation both in order to gain a better understanding of the complex anatomical structure of the root canals and to increase the efficiency of the instruments and methods used during the canal preparation. Sodium hypochlorite (NaOCl) solution is the standard irrigation agent for cleaning and disinfection of root canal. In this study, the effect of NaOCI on level of IL-8 different concentration will be evaluated.
NaOCIDrug
NaOCI
| Study group | Role | What they receive |
|---|---|---|
| 1% NaOCIL | Active comparator | 2 ml of 1% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Receives: Other: Irrigant concentration; Drug: NaOCI |
| 2.5% NaOCI | Active comparator | 2 ml of 2.5% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Receives: Other: Irrigant concentration; Drug: NaOCI |
| 5.25% NaOCI | Active comparator | 2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Receives: Other: Irrigant concentration; Drug: NaOCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-8 Level
Concentration of IL-8 in GCF
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start20 Mar 2022 (estimated)
- Primary completion20 Jun 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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
- Model description
- Group 1; 2 ml of 1% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 2: 2 ml of 2.5% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 3; 2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Özlek, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277246
- Sponsor's protocol ID
- 11/15.12.2021
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 14 Mar 2022
- 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 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Different Concentrations of NaOCI on IL-8 Level During Endodontic Treatment of Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05277246
- Acronym / sponsor ID
- 11/15.12.2021
- Conditions
- Irreversible Pulpitis
- Keywords
- Gingival cervicular fluidi, IL-8
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 Mar 2022 (estimated)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 14 Mar 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 objective is to compare various concentrations of NAOCL during Root canal treatment and their effect on IL-8 at the gingival crevicular fluid. Despite the current advancement of beneficial endodontic diagnostic methods, such as pulp sensitivity tests and periapical radiographs, clinical outcomes do not always correspond with the arrangement of the histological condition of the pulp. At this point, the need for other ways to help diagnose pathological pulpal disease has arisen. This situation has influenced researchers to use molecular evaluation as an alternative route in endodontic diagnosis. Biomarkers, functional at the cellular and molecular level, are crucial elements within the pathological process. Detection of molecular markers is considered an ancillary method for diagnosing the pathological condition of the pulp tissue.An increase in inflammatory cells in the carious or traumatized dentinal pulp complex has been reported. In the presence of bacteria, immune cells produce interleukin-6 (IL6), interleukin-8 (CXCL8), and tumor necrosis factor-alpha (TNF) in the pulp. Interleukin-8 is frequently expressed in endothelial cells of inflamed pulp and rarely in the normal pulp. Karapanou et al. (2008) revealed that interleukin-8 was more greatly released in teeth with irreversible pulpitis than in the control group in a research in which gingival crevicular fluid with acute pulpitis was analyzed. the pulp tissue and gingival crevicular fluid of teeth with symptomatic irreversible pulpitis were dramatically augmented by these indicators compared with healthy teeth. Furthermore, they concluded that the levels of NKA, SP, IL8, and MMP8 in the gingival crevicular fluid decreased one week after endodontic treatment of teeth with pulpitis. Subsequently, it has been reported that patients with symptomatic irreversible pulpitis with high initial pain scores have higher levels of SP, IL8, and MMP8 in the pulp tissue samples than those with low pain scores.It is recommended to use NaOCl concentration between 0.5% and 5.25% as an irrigation solution in root canal treatment (6). The effectiveness of NaOCl increases with increasing concentration, but its toxicity is known to be proportional to concentration.
Therefore, there is no consensus on the optimal concentration of NaOCL. When articles were reviewed, it was found that inflammation of the pulp and biomarker levels are correlated. For this reason, we believe that whether or not NaOCl solution at various concentrations causes inflammation can be analyzed by the level of IL-8. Upon review of the literature, it was found that no studies investigated the influence of NaOCl solution on biomarkers in the gingival crevicular fluid. The research described below contributes to the literature on the optimal concentration of NaOCl to use.
Detailed description
The study is to be carried out in 84 medically fit patients, aged 18-50 years, who were diagnosed and followed up at Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Endodontics, (The number of patients was determined according to "power analysis.") Lower first and second molars (36,37,46,47) diagnosed with irreversible pulpitis will be included in the study as an experimental group.
As the control group, the contralateral teeth of the related teeth will be evaluated. Patients with periapical lesions and open apex teeth will not be included in the study group. Before treatment, patients will be asked to determine their pain level according to a 0-10 VAS scale, and this value will be recorded for comparison with post-treatment. Teeth (experimental and control ) to be sampled from the gingival crevicular fluid will be isolated with a cotton roll and saliva ejector.
The supragingival plaque will be carefully removed using a curette. The teeth to be inspected will be dried with air for 10 seconds. A Periopaper strip (Oraflow, Smithtown, NY, USA) will be placed in the interproximal mesial gingival sulcus of the affected tooth until slight resistance is confronted and is removed after 1 min. Samples contaminated with blood or saliva will not be involved in the study. All collected periopaper strips will be placed in 1.5 ml Eppendorf tubes (Labosel, Istanbul, Turkey) and stored at -80 ° C until analysis.
After applying 2ml local anesthesia (Maxicaine DS strong (Vem, İstanbul, Türkiye)), the access cavity will be opened with diamond bur. The working length will be determined using the apex locator (DentsplyMaillefer, UK) and the radiographic x-ray by placing a K file #15 (Mani Inc, Tochigi, Japan) into the root canals until the apical constriction.
The shaping process of the root canals will be accomplished by ProTaperNext (DentsplyMaillefer, Baillagues, Switzerland) up to the X3 instrument as standard in each patient. The study will be randomly divided into 3 groups (n= ) according to the irrigation solution used during shaping (G1: 1% NaOCl; G2: 2.5% NaOCl; G3: 5.25% NaOCl). 2 ml of irrigation solution will be applied after each file.
A 2 ml dental injector with a 27 gauge dental needle will be used; the tip of the needle will be adjusted to reach two-thirds of the working length. For the final irrigation of the root canals that have completed the shaping process, 5 ml of 17% EDTA solution and NaOCl solution will be used, respectively. Later on, the canals will be dried with sterile paper points.
Root canals will be obturated with sterile gutta-perchas and AH+ (Dentsply De Trey, Konstanz, Germany) root canal sealer using the single cone technique.
Finally, the teeth will be restored using composite. One week after treatment, the patient will be called for a follow-up appointment.
The patients will be asked to determine the pain level according to the VAS scale, and it will be recorded. A specimen of gingival crevicular fluid will be taken from the root canal treated teeth in the same manner as at the commencement and stored. The amount of IL-8 in the gingival crevicular fluid will be measured with an enzyme-linked immunoassay (ELISA) kit (Cayman, Ann Arbor, MI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Group 1; 2 ml of 1% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 2: 2 ml of 2.5% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 3; 2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.
| Arm | Type | Receives |
|---|---|---|
| 1% NaOCIL | Active comparator | Other: Irrigant concentration, Drug: NaOCI2 ml of 1% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. |
| 2.5% NaOCI | Active comparator | Other: Irrigant concentration, Drug: NaOCI2 ml of 2.5% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. |
| 5.25% NaOCI | Active comparator | Other: Irrigant concentration, Drug: NaOCI2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Key exclusion criteria (6 listed)
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
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 |
|---|---|---|
| Irrigant concentrationThe success of endodontic treatment is directly related to infection control. In successful endodontic treatment, it is necessary to perform an ideal irrigation both in order to gain a better understanding of the complex anatomical structure of the root canals and to increase the efficiency of the instruments and methods used during the canal preparation. Sodium hypochlorite (NaOCl) solution is the standard irrigation agent for cleaning and disinfection of root canal. In this study, the effect of NaOCI on level of IL-8 different concentration will be evaluated. | Other | 1% NaOCIL, 2.5% NaOCI, 5.25% NaOCI |
| NaOCINaOCI | Drug | 1% NaOCIL, 2.5% NaOCI, 5.25% NaOCI |
Primary outcome
IL-8 Level
Time frame: 6 months
Concentration of IL-8 in GCF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigant concentration and NaOCI in people with Irreversible Pulpitis, run by Yuzuncu Yil University.
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 6 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hacer Aydınyurt, PhD (905304589710, hacersahin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-8 Level (time frame: 6 months). 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 14 Mar 2022.