Irreversible PulpitisNCT06237985
Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments
A study testing ProTaper Gold file system, OneShape file system and TruNatomy file system in people with Irreversible Pulpitis, run by Saglik Bilimleri Universitesi.
Trial summary
The goal of this clinical trial is to evaluate the expression of inflammatory mediators in the crevicular fluid and periodontal ligament after one-visit root canal treatment of mandibular molars of patients with asymptomatic irreversible pulpitis using 3 different file systems. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- ProTaper Gold file system, OneShape file system and TruNatomy file system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 30 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-60
- Patients with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination
- Patients with pain pain between 0 and 3 on the VAS scale
- Patients without any systemic disease
- Mandibular first and second molar teeth without complex root canal anatomy, calcifications, periapical lesions, deep periodontal pockets (PAI<2), and any fractures or cracks
Who cannot join
- Patients with acute symptoms
- Patients who have a history of taking analgesics 48 h or antibiotics within 1 month prior to the visit
- Patients who are being pregnant and lactating
- Patients with several periodontal problems
- Patients with systemic disease
- Teeth with immature root apexes
- Trauma cases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments: a Randomized Clinical Trial
The goal of this clinical trial is to evaluate the expression of inflammatory mediators in the crevicular fluid and periodontal ligament after one-visit root canal treatment of mandibular molars of patients with asymptomatic irreversible pulpitis using 3 different file systems.
The main question it aims to answer is: Does conservative root canal preparation cause decreased expression of inflammatory mediators compared to conventional root canal preparation?
In this context, patients will be divided into 3 groups based on the file systems as follows: ProTaper Gold, OneShape, and TruNatomy up to apical size #25. Both inflammatory mediator expression and postoperative VAS values will be compared.
Read the detailed description
The below-mentioned steps will be performed in the scope of this study:
- Ethical approval has been obtained.
- The sample size calculation was performed (90% power, 0.597 effect size, 20 patients per group)
- Patients aged 18-60 with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination and without any systemic disease will be included.
- Only mandibular first and second molar teeth that do not have complex anatomy, periapical lesions, deep periodontal pockets (PAI<2), and any fractures or cracks will be included.
- Patients with acute symptoms, a history of taking analgesics 48 hours or antibiotics within 1 month prior to the visit, being pregnant and lactating, and having several periodontal problems will be excluded.
- Immature apexes and trauma cases will also be excluded. 6) Selected patients will be informed about the study, and written consent will be obtained from all patients.
- Patients will be randomly distributed into groups using a software (www.randomizer.org). Moreover, patients will be blinded regarding the file system they use.
- A single operator will perform all endodontic treatments in the same clinical conditions.
- Before starting the treatment, the baseline Visual Analogue Scale (VAS) values will be recorded.
- For baseline inflammatory mediator assessment, gingival crevicular fluid samples from mesial and distal surfaces from teeth with #20 paper points for 30 seconds and paper points will be placed into Eppendorf tubes and kept at -80 ° until the analysis is performed.
- After the administration of the local anaesthesia, teeth will be isolated with a rubber dam, and access cavities will be prepared. Then, teeth will be allotted to one of the following file systems:
- Group 1 (ProTaper Gold file system): Sx-S1-S2-F1-F2 (for mesial canals), F3 (for distal canal)
- Group 2 (OneShape file system): 25/.06 (for mesial canals), additional file for distal canal if needed.
- Group 3 (TruNatomy file system): 17/.02, 20/.04 ve 26/.04 (for mesial canals), 36/.03 (for distal canal.)
- 2 mL 2.5% sodium hypochlorite (NaOCl) will be used between files and final irrigation will be performed using 5 mL NaOCL, 5 mL 17% ethylenediaminetetraacetic acid (EDTA), and 5 mL distilled water with 31-G side vented needle.
- After drying the canals, #15 paper point will be placed inside mesial canals for 1 minute, 2 mm beyond the apex. Afterwards, paper points will be placed into Eppendorf tubes and kept at -80 ° until the analysis is performed.
- Root canals will be obturated with resin-based sealer and gutta-percha. 15) Permanent restoration will be done using composite. 16) Patients will be recalled at 24 and 72 hours, and gingival crevicular fluid samples from mesial and distal surfaces will be obtained using an above-mentioned method.
- Measurement of postoperative pain after treatment with a VAS scale at 24, 48, and 72 hours will also be recorded.
- Measurement of pain mediators (Substance P, Prostaglandin E2, interleukin (IL) 6, and IL-10) will be performed with ELISA kits. All samples will be analyzed in duplicate.
- Based on the readings obtained from the spectrophotometer, results will be fitted to the standard curve and presented in the form of picograms per millilitre (pg/mL).
- Statistical analysis will be conducted.
- Conditions
- Irreversible Pulpitis
- Being tested
- ProTaper Gold file system, OneShape file system, TruNatomy file system
- Keywords
- postoperative pain, endodontics, ELISA, conservative instrumentation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTaper Gold file systemProcedure or surgery
According to the manufacturers ' instructions, root canal treatments will be conducted with the ProTaper Gold rotary file system up to F2 for mesial canals.
OneShape file systemProcedure or surgery
According to the manufacturers ' instructions, root canal treatments will be conducted with the OneShape rotary file system up to 25/.06 for mesial canals.
TruNatomy file systemProcedure or surgery
According to the manufacturers ' instructions, root canal treatments will be conducted with the TruNatomy rotary file system up to 26/.04 for mesial canals.
| Study group | Role | What they receive |
|---|---|---|
| ProTaper Gold file system | Experimental | Sx-S1-S2-F1-F2 files for mesial canals and F3 file for distal canal with 350 rpm speed and 2 Ncm torque will be used via an endodontic motor. Receives: Procedure: ProTaper Gold file system |
| OneShape file system | Experimental | 25/.06 file for mesial canals with 350 rpm and 4 Ncm torque will be used via an endodontic motor. Receives: Procedure: OneShape file system |
| TruNatomy file system | Experimental | 17/.02, 20/.04 ve 26/.04 files for mesial canals and 36/.03 file for distal canal with 500 rpm speed and 1.5 Ncm torque will be used via an endodontic motor. Receives: Procedure: TruNatomy file system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Substance P
Measurement of Substance P
Measured: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Prostaglandin E2
Measurement of Prostaglandin E2
Measured: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Release of inflammatory mediators
Measurement of Prostaglandin IL-6
Measured: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of IL-10
Measurement of IL-10
Measured: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Secondary outcomes (1)
Postoperative pain assessment using visual analog scale
Postoperative pain assessment using visual analog scale
Measured: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion15 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Patients will be divided into 3 different file system randomly in order to measure the inflammatory mediators and postoperative pain.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla Nur Usta, Saglik Bilimleri Universitesi
- Investigators
- Serpil Karaoğlanoğlu, Professor, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237985
- Sponsor's protocol ID
- SBU-GFOD-ENDO-SILANURUSTA-001
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Within the scope of the necessity of protecting the individual information of the patients, it is considered that the recorded data will not be shared.
Publications
Kasikci S, Turker SA, Guven B. Effect of different retreatment files using different kinematics on the release of inflammatory mediators in root canal retreatment of single-rooted teeth: a randomized clinical trial. Clin Oral Investig. 2023 Jun;27(6):3189-3196. doi: 10.1007/s00784-023-04930-6. Epub 2023 Mar 1.
PubMed 36856848Bicakci H, Capar ID, Genc S, Ihtiyar A, Sutcu R. Influence of Rotary Instrumentation with Continuous Irrigation on Pain and Neuropeptide Release Levels: A Randomized Clinical Trial. J Endod. 2016 Nov;42(11):1613-1619. doi: 10.1016/j.joen.2016.08.010.
PubMed 27788771Nunez N, Erdogan O, Casey SM, Hernandez R, Tan S, Gibbs JL. Elevated Cytokine Levels in Gingival Crevicular Fluid of Teeth with Apical Periodontitis. J Endod. 2023 Jun;49(6):657-663. doi: 10.1016/j.joen.2023.03.010. Epub 2023 Mar 24.
PubMed 36965768Shin SJ, Lee W, Lee JI, Baek SH, Kum KY, Shon WJ, Bae KS. Matrix metalloproteinase-8 and substance P levels in gingival crevicular fluid during endodontic treatment of painful, nonvital teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Oct;112(4):548-54. doi: 10.1016/j.tripleo.2011.04.026. Epub 2011 Aug 10.
PubMed 21831678Canakci BC, Er O, Genc Sen O, Sut N. The effect of two rotary and two reciprocating NiTi systems on postoperative pain after root canal retreatment on single-rooted incisor teeth: A randomized controlled trial. Int Endod J. 2021 Nov;54(11):2016-2024. doi: 10.1111/iej.13609. Epub 2021 Aug 29.
PubMed 34383324
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06237985
- Acronym / sponsor ID
- SBU-GFOD-ENDO-SILANURUSTA-001
- Conditions
- Irreversible Pulpitis
- Keywords
- postoperative pain, endodontics, ELISA, conservative instrumentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 2 Feb 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.
The goal of this clinical trial is to evaluate the expression of inflammatory mediators in the crevicular fluid and periodontal ligament after one-visit root canal treatment of mandibular molars of patients with asymptomatic irreversible pulpitis using 3 different file systems.
The main question it aims to answer is: Does conservative root canal preparation cause decreased expression of inflammatory mediators compared to conventional root canal preparation?
In this context, patients will be divided into 3 groups based on the file systems as follows: ProTaper Gold, OneShape, and TruNatomy up to apical size #25. Both inflammatory mediator expression and postoperative VAS values will be compared.
Detailed description
The below-mentioned steps will be performed in the scope of this study:
- Ethical approval has been obtained.
- The sample size calculation was performed (90% power, 0.597 effect size, 20 patients per group)
- Patients aged 18-60 with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination and without any systemic disease will be included.
- Only mandibular first and second molar teeth that do not have complex anatomy, periapical lesions, deep periodontal pockets (PAI<2), and any fractures or cracks will be included.
- Patients with acute symptoms, a history of taking analgesics 48 hours or antibiotics within 1 month prior to the visit, being pregnant and lactating, and having several periodontal problems will be excluded.
- Immature apexes and trauma cases will also be excluded. 6) Selected patients will be informed about the study, and written consent will be obtained from all patients.
- Patients will be randomly distributed into groups using a software (www.randomizer.org). Moreover, patients will be blinded regarding the file system they use.
- A single operator will perform all endodontic treatments in the same clinical conditions.
- Before starting the treatment, the baseline Visual Analogue Scale (VAS) values will be recorded.
- For baseline inflammatory mediator assessment, gingival crevicular fluid samples from mesial and distal surfaces from teeth with #20 paper points for 30 seconds and paper points will be placed into Eppendorf tubes and kept at -80 ° until the analysis is performed.
- After the administration of the local anaesthesia, teeth will be isolated with a rubber dam, and access cavities will be prepared. Then, teeth will be allotted to one of the following file systems:
- Group 1 (ProTaper Gold file system): Sx-S1-S2-F1-F2 (for mesial canals), F3 (for distal canal)
- Group 2 (OneShape file system): 25/.06 (for mesial canals), additional file for distal canal if needed.
- Group 3 (TruNatomy file system): 17/.02, 20/.04 ve 26/.04 (for mesial canals), 36/.03 (for distal canal.)
- 2 mL 2.5% sodium hypochlorite (NaOCl) will be used between files and final irrigation will be performed using 5 mL NaOCL, 5 mL 17% ethylenediaminetetraacetic acid (EDTA), and 5 mL distilled water with 31-G side vented needle.
- After drying the canals, #15 paper point will be placed inside mesial canals for 1 minute, 2 mm beyond the apex. Afterwards, paper points will be placed into Eppendorf tubes and kept at -80 ° until the analysis is performed.
- Root canals will be obturated with resin-based sealer and gutta-percha. 15) Permanent restoration will be done using composite. 16) Patients will be recalled at 24 and 72 hours, and gingival crevicular fluid samples from mesial and distal surfaces will be obtained using an above-mentioned method.
- Measurement of postoperative pain after treatment with a VAS scale at 24, 48, and 72 hours will also be recorded.
- Measurement of pain mediators (Substance P, Prostaglandin E2, interleukin (IL) 6, and IL-10) will be performed with ELISA kits. All samples will be analyzed in duplicate.
- Based on the readings obtained from the spectrophotometer, results will be fitted to the standard curve and presented in the form of picograms per millilitre (pg/mL).
- Statistical analysis will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be divided into 3 different file system randomly in order to measure the inflammatory mediators and postoperative pain.
| Arm | Type | Receives |
|---|---|---|
| ProTaper Gold file system | Experimental | Procedure: ProTaper Gold file systemSx-S1-S2-F1-F2 files for mesial canals and F3 file for distal canal with 350 rpm speed and 2 Ncm torque will be used via an endodontic motor. |
| OneShape file system | Experimental | Procedure: OneShape file system25/.06 file for mesial canals with 350 rpm and 4 Ncm torque will be used via an endodontic motor. |
| TruNatomy file system | Experimental | Procedure: TruNatomy file system17/.02, 20/.04 ve 26/.04 files for mesial canals and 36/.03 file for distal canal with 500 rpm speed and 1.5 Ncm torque will be used via an endodontic motor. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18-60
- Patients with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination
- Patients with pain pain between 0 and 3 on the VAS scale
- Patients without any systemic disease
- Mandibular first and second molar teeth without complex root canal anatomy, calcifications, periapical lesions, deep periodontal pockets (PAI<2), and any fractures or cracks
Key exclusion criteria (7 listed)
- Patients with acute symptoms
- Patients who have a history of taking analgesics 48 h or antibiotics within 1 month prior to the visit
- Patients who are being pregnant and lactating
- Patients with several periodontal problems
- Patients with systemic disease
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 |
|---|---|---|
| ProTaper Gold file systemAccording to the manufacturers ' instructions, root canal treatments will be conducted with the ProTaper Gold rotary file system up to F2 for mesial canals. | Procedure or surgery | ProTaper Gold file system |
| OneShape file systemAccording to the manufacturers ' instructions, root canal treatments will be conducted with the OneShape rotary file system up to 25/.06 for mesial canals. | Procedure or surgery | OneShape file system |
| TruNatomy file systemAccording to the manufacturers ' instructions, root canal treatments will be conducted with the TruNatomy rotary file system up to 26/.04 for mesial canals. | Procedure or surgery | TruNatomy file system |
Primary outcome
Measurement of Substance P
Time frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Substance P
Measurement of Prostaglandin E2
Time frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Prostaglandin E2
Release of inflammatory mediators
Time frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Prostaglandin IL-6
Measurement of IL-10
Time frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of IL-10
1 secondary outcome
Postoperative pain assessment using visual analog scale
Time frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Results publication: PubMed 36856848Kasikci S, Turker SA, Guven B. Effect of different retreatment files using different kinematics on the release of inflammatory mediators in root canal retreatment of single-rooted teeth: a randomized clinical trial. Clin Oral Investig. 2023 Jun;27(6):3189-3196. doi: 10.1007/s00784-023-04930-6. Epub 2023 Mar 1.
- Results publication: PubMed 27788771Bicakci H, Capar ID, Genc S, Ihtiyar A, Sutcu R. Influence of Rotary Instrumentation with Continuous Irrigation on Pain and Neuropeptide Release Levels: A Randomized Clinical Trial. J Endod. 2016 Nov;42(11):1613-1619. doi: 10.1016/j.joen.2016.08.010.
- Results publication: PubMed 36965768Nunez N, Erdogan O, Casey SM, Hernandez R, Tan S, Gibbs JL. Elevated Cytokine Levels in Gingival Crevicular Fluid of Teeth with Apical Periodontitis. J Endod. 2023 Jun;49(6):657-663. doi: 10.1016/j.joen.2023.03.010. Epub 2023 Mar 24.
- Results publication: PubMed 21831678Shin SJ, Lee W, Lee JI, Baek SH, Kum KY, Shon WJ, Bae KS. Matrix metalloproteinase-8 and substance P levels in gingival crevicular fluid during endodontic treatment of painful, nonvital teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Oct;112(4):548-54. doi: 10.1016/j.tripleo.2011.04.026. Epub 2011 Aug 10.
- Results publication: PubMed 34383324Canakci BC, Er O, Genc Sen O, Sut N. The effect of two rotary and two reciprocating NiTi systems on postoperative pain after root canal retreatment on single-rooted incisor teeth: A randomized controlled trial. Int Endod J. 2021 Nov;54(11):2016-2024. doi: 10.1111/iej.13609. Epub 2021 Aug 29.
- Individual participant dataSharing planned: No. Within the scope of the necessity of protecting the individual information of the patients, it is considered that the recorded data will not be shared.
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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.
Serpil Karaoğlanoğlu, Professor study director
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
A study testing ProTaper Gold file system, OneShape file system and TruNatomy file system in people with Irreversible Pulpitis, run by Saglik Bilimleri Universitesi.
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 5 inclusion and 7 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 2 Feb 2024. 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 Sıla Usta, DDS (0090 507 279 5558, silandeniz29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Substance P (time frame: Before root canal treatment (Day 0), at 24 hours, and at 72 hours). The study lists 4 primary outcomes in all. 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 NCT06237985, which also lists 5 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 2 Feb 2024.