Postoperative PainNCT07163065
Evaluation of Systemic Inflammatory Index and Biomarkers in Relation to Inferior Alveolar Nerve Block Success and Postoperative Pain
An observational study of Postoperative Pain and Inferior Alveolar Nerve Block Failure, run by KEZBAN MELTEM ÇOLAK at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship between systemic inflammatory markers and the effectiveness of inferior alveolar nerve block anesthesia in patients undergoing dental treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Inferior Alveolar Nerve Block Failure, Inflammation Biomarkers
- What is being tested?
- Inferior Alveolar Nerve Block Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2024to 15 Oct 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-65 years) requiring mandibular dental treatment under inferior alveolar nerve block anesthesia at Atatürk University Faculty of Dentistry, Department of Endodontics.
Who may be able to join
- Patients aged between 18 and 65 years.
- Patients with a pain score greater than 54 on the Heft-Parker Visual Analog Scale (VAS).
- Patients classified as ASA I according to the American Society of Anesthesiologists (ASA).
- Teeth with probing depths less than 3 mm, suitable for rubber dam placement and restoration.
- Vital mandibular molar teeth with a clinical diagnosis of irreversible pulpitis, confirmed by pulp vitality tests (electric pulp testing and cold testing).
- Presence of bleeding upon access to the pulp chamber.
Show all 9Show fewer
- No use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last 12 hours.
- Absence of allergy to articaine.
- Patient's consent to provide a blood sample.
Who cannot join
- Patients classified as ASA II or higher.
- Pregnant women or those with suspected pregnancy.
- Patients with periodontal pockets greater than 3 mm in the involved tooth.
- Patients who received treatment with NSAIDs within the last 12 hours.
- Patients allergic to articaine.
- Teeth that had undergone previous endodontic treatment.
- Teeth with extensive structural loss preventing rubber dam isolation.
- Presence of internal or external root resorption.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Dentistry, Department of Endodontics
Erzurum, Erzurum, 25240
About this study
Official title: Effect of Systemic Inflammatory Index and Other Biomarkers on Inferior Alveolar Nerve Block Success and Postoperative Pain
This study aims to investigate the relationship between systemic inflammatory markers and the effectiveness of inferior alveolar nerve block anesthesia in patients undergoing dental treatment. The primary focus is on the Systemic Inflammatory Index (SII) and other inflammatory biomarkers, and how they may influence both the success of anesthesia and the intensity of postoperative pain. By analyzing blood samples and clinical outcomes, the study will provide new insights into the role of systemic inflammation in anesthesia effectiveness and postoperative pain control. The findings may help clinicians predict anesthetic success and improve pain management strategies in dental practice.
Read the detailed description
Pulpitis is among the most common causes of orofacial pain. Irreversible pulpitis is characterized by a painful pulpal response to thermal stimuli that does not subside immediately after the removal of the stimulus. Pain is an unpleasant experience associated with actual or potential tissue damage. It is a subjective concept, and the pain threshold varies among individuals. Cold and heat tests are widely used in clinical practice for the diagnosis of symptomatic irreversible pulpitis. Irreversible pulpitis mainly arises due to infection caused by dental caries or the loss of restoration seal and microleakage. Dental trauma, pulpal exposure, and cracks can also lead to severe pulpitis. Pain associated with irreversible pulpitis accounts for more than 45% of emergency dental visits.
A detailed history of pain is essential, and it is often described as severe, dull, and throbbing; this pain may intensify with thermal or postural changes and can result in sleep disturbance. It tends to persist for prolonged periods (minutes to hours) and is generally unresponsive to analgesics. Patients also frequently report spontaneous and unprovoked sharp pains.
Achieving successful pulpal anesthesia during endodontic treatment of teeth with symptomatic irreversible pulpitis is critical for patient pain and stress management; however, this remains particularly challenging in mandibular teeth due to the inability of the inferior alveolar nerve block (IANB) to consistently provide profound anesthesia. Increased acidity in the inflamed pulp reduces the amount of basic anesthetic penetrating the nerve membrane, thereby delaying or preventing pulpal anesthesia.
Lip numbness, which typically occurs after anesthesia (i.e., loss of tactile sensation due to A-beta fiber blockade), is commonly regarded as an indicator that pulpal pain fibers (C and A-delta fibers) are also anesthetized and that the patient is ready for treatment. However, while tactile sensation is mediated by A-beta fibers, pain is transmitted via C and A-delta fibers. Local anesthetics block thick myelinated A-beta fibers and thin myelinated A-delta fibers at much lower concentrations than unmyelinated C fibers. Local anesthetics thus preferentially block myelinated fibers. Therefore, in healthy patients, the presence of lip numbness may be misleading for assessing pulpal anesthesia success. In patients with irreversible pulpitis, this method of assessment is even more unreliable.
**Several theories have been proposed to explain anesthetic failure. However, no studies have investigated the relationship between systemic inflammation and anesthetic success. The systemic immune-inflammation index (SII) is a novel biomarker for inflammation and is calculated as (neutrophil count × platelet count) / lymphocyte count. In our study, SII and other inflammatory markers will be evaluated. These additional inflammatory indices are as follows:
Aggregate index of systemic inflammation (AISI) = neutrophil count × monocyte count × platelet count / lymphocyte count
Platelet-to-lymphocyte ratio (PLR) = platelet count / lymphocyte count
Systemic inflammatory index (SII) = neutrophil count / PLR
Neutrophil-to-lymphocyte ratio (NLR) = neutrophil count / lymphocyte count.**
Moreover, although NLR has been used as an indicator of the inflammatory response in numerous diseases, there are insufficient data regarding its effects on postoperative pain, which is closely associated with acute inflammation. The aim of this study is to investigate the effects of systemic inflammatory markers, particularly SII and NLR, on the success of inferior alveolar nerve block anesthesia and postoperative pain.
- Conditions
- Postoperative Pain, Inferior Alveolar Nerve Block Failure, Inflammation Biomarkers, Dental Anesthesia Complications
- Being tested
- Inferior Alveolar Nerve Block Anesthesia
- Keywords
- Systemic Inflammatory Index (SII), Neutrophil-to-Lymphocyte Ratio (NLR), Dental Anesthesia, Mandibular Block, Endodontic Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Alveolar Nerve Block AnesthesiaProcedure or surgery
Standard inferior alveolar nerve block anesthesia performed with lidocaine and epinephrine for mandibular dental treatment. Success rate and postoperative pain outcomes will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Inferior Alveolar Nerve Block | Adult patients requiring dental treatment under inferior alveolar nerve block anesthesia. Participants will undergo standard IANB anesthesia, and postoperative pain will be evaluated along with systemic inflammatory markers obtained from blood samples. Receives: Procedure: Inferior Alveolar Nerve Block Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Inferior Alveolar Nerve Block Anesthesia
Proportion of patients achieving successful anesthesia, defined as absence of pain during dental treatment following inferior alveolar nerve block.
Measured: Within 15 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start27 Sep 2024
- Primary completion1 Nov 2024
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- 150 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- KEZBAN MELTEM ÇOLAK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, KEZBAN MELTEM ÇOLAK, Ataturk University
- Investigators
- KEZBAN MELTEM ÇOLAK, Principal investigator, Atatürk University, Faculty of Dentistry, Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163065
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/558
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dziedzic EA, Gasior JS, Tuzimek A, Paleczny J, Junka A, Dabrowski M, Jankowski P. Investigation of the Associations of Novel Inflammatory Biomarkers-Systemic Inflammatory Index (SII) and Systemic Inflammatory Response Index (SIRI)-With the Severity of Coronary Artery Disease and Acute Coronary Syndrome Occurrence. Int J Mol Sci. 2022 Aug 23;23(17):9553. doi: 10.3390/ijms23179553.
PubMed 36076952Gibson PH, Croal BL, Cuthbertson BH, Small GR, Ifezulike AI, Gibson G, Jeffrey RR, Buchan KG, El-Shafei H, Hillis GS. Preoperative neutrophil-lymphocyte ratio and outcome from coronary artery bypass grafting. Am Heart J. 2007 Nov;154(5):995-1002. doi: 10.1016/j.ahj.2007.06.043.
PubMed 17967611
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Inflammatory Index and Other Biomarkers on Inferior Alveolar Nerve Block Success and Postoperative Pain
- ClinicalTrials.gov ID
- NCT07163065
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/558
- Conditions
- Postoperative Pain, Inferior Alveolar Nerve Block Failure, Inflammation Biomarkers, Dental Anesthesia Complications
- Keywords
- Systemic Inflammatory Index (SII), Neutrophil-to-Lymphocyte Ratio (NLR), Dental Anesthesia, Mandibular Block, Endodontic Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- KEZBAN MELTEM ÇOLAKUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 9 Sep 2025 (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.
This study aims to investigate the relationship between systemic inflammatory markers and the effectiveness of inferior alveolar nerve block anesthesia in patients undergoing dental treatment. The primary focus is on the Systemic Inflammatory Index (SII) and other inflammatory biomarkers, and how they may influence both the success of anesthesia and the intensity of postoperative pain. By analyzing blood samples and clinical outcomes, the study will provide new insights into the role of systemic inflammation in anesthesia effectiveness and postoperative pain control. The findings may help clinicians predict anesthetic success and improve pain management strategies in dental practice.
Detailed description
Pulpitis is among the most common causes of orofacial pain. Irreversible pulpitis is characterized by a painful pulpal response to thermal stimuli that does not subside immediately after the removal of the stimulus. Pain is an unpleasant experience associated with actual or potential tissue damage. It is a subjective concept, and the pain threshold varies among individuals. Cold and heat tests are widely used in clinical practice for the diagnosis of symptomatic irreversible pulpitis. Irreversible pulpitis mainly arises due to infection caused by dental caries or the loss of restoration seal and microleakage. Dental trauma, pulpal exposure, and cracks can also lead to severe pulpitis. Pain associated with irreversible pulpitis accounts for more than 45% of emergency dental visits.
A detailed history of pain is essential, and it is often described as severe, dull, and throbbing; this pain may intensify with thermal or postural changes and can result in sleep disturbance. It tends to persist for prolonged periods (minutes to hours) and is generally unresponsive to analgesics. Patients also frequently report spontaneous and unprovoked sharp pains.
Achieving successful pulpal anesthesia during endodontic treatment of teeth with symptomatic irreversible pulpitis is critical for patient pain and stress management; however, this remains particularly challenging in mandibular teeth due to the inability of the inferior alveolar nerve block (IANB) to consistently provide profound anesthesia. Increased acidity in the inflamed pulp reduces the amount of basic anesthetic penetrating the nerve membrane, thereby delaying or preventing pulpal anesthesia.
Lip numbness, which typically occurs after anesthesia (i.e., loss of tactile sensation due to A-beta fiber blockade), is commonly regarded as an indicator that pulpal pain fibers (C and A-delta fibers) are also anesthetized and that the patient is ready for treatment. However, while tactile sensation is mediated by A-beta fibers, pain is transmitted via C and A-delta fibers. Local anesthetics block thick myelinated A-beta fibers and thin myelinated A-delta fibers at much lower concentrations than unmyelinated C fibers. Local anesthetics thus preferentially block myelinated fibers. Therefore, in healthy patients, the presence of lip numbness may be misleading for assessing pulpal anesthesia success. In patients with irreversible pulpitis, this method of assessment is even more unreliable.
**Several theories have been proposed to explain anesthetic failure. However, no studies have investigated the relationship between systemic inflammation and anesthetic success. The systemic immune-inflammation index (SII) is a novel biomarker for inflammation and is calculated as (neutrophil count × platelet count) / lymphocyte count. In our study, SII and other inflammatory markers will be evaluated. These additional inflammatory indices are as follows:
Aggregate index of systemic inflammation (AISI) = neutrophil count × monocyte count × platelet count / lymphocyte count
Platelet-to-lymphocyte ratio (PLR) = platelet count / lymphocyte count
Systemic inflammatory index (SII) = neutrophil count / PLR
Neutrophil-to-lymphocyte ratio (NLR) = neutrophil count / lymphocyte count.**
Moreover, although NLR has been used as an indicator of the inflammatory response in numerous diseases, there are insufficient data regarding its effects on postoperative pain, which is closely associated with acute inflammation. The aim of this study is to investigate the effects of systemic inflammatory markers, particularly SII and NLR, on the success of inferior alveolar nerve block anesthesia and postoperative pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Inferior Alveolar Nerve Block | – | Procedure: Inferior Alveolar Nerve Block AnesthesiaAdult patients requiring dental treatment under inferior alveolar nerve block anesthesia. Participants will undergo standard IANB anesthesia, and postoperative pain will be evaluated along with systemic inflammatory markers obtained from blood samples. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-65 years) requiring mandibular dental treatment under inferior alveolar nerve block anesthesia at Atatürk University Faculty of Dentistry, Department of Endodontics.
Key inclusion criteria (9 listed)
- Patients aged between 18 and 65 years.
- Patients with a pain score greater than 54 on the Heft-Parker Visual Analog Scale (VAS).
- Patients classified as ASA I according to the American Society of Anesthesiologists (ASA).
- Teeth with probing depths less than 3 mm, suitable for rubber dam placement and restoration.
- Vital mandibular molar teeth with a clinical diagnosis of irreversible pulpitis, confirmed by pulp vitality tests (electric pulp testing and cold testing).
Key exclusion criteria (8 listed)
- Patients classified as ASA II or higher.
- Pregnant women or those with suspected pregnancy.
- Patients with periodontal pockets greater than 3 mm in the involved tooth.
- Patients who received treatment with NSAIDs within the last 12 hours.
- Patients allergic to articaine.
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 |
|---|---|---|
| Inferior Alveolar Nerve Block AnesthesiaStandard inferior alveolar nerve block anesthesia performed with lidocaine and epinephrine for mandibular dental treatment. Success rate and postoperative pain outcomes will be recorded | Procedure or surgery | Patients Undergoing Inferior Alveolar Nerve Block |
Primary outcome
Success Rate of Inferior Alveolar Nerve Block Anesthesia
Time frame: Within 15 minutes after injection
Proportion of patients achieving successful anesthesia, defined as absence of pain during dental treatment following inferior alveolar nerve block.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publication: PubMed 36076952Dziedzic EA, Gasior JS, Tuzimek A, Paleczny J, Junka A, Dabrowski M, Jankowski P. Investigation of the Associations of Novel Inflammatory Biomarkers-Systemic Inflammatory Index (SII) and Systemic Inflammatory Response Index (SIRI)-With the Severity of Coronary Artery Disease and Acute Coronary Syndrome Occurrence. Int J Mol Sci. 2022 Aug 23;23(17):9553. doi: 10.3390/ijms23179553.
- Results publication: PubMed 17967611Gibson PH, Croal BL, Cuthbertson BH, Small GR, Ifezulike AI, Gibson G, Jeffrey RR, Buchan KG, El-Shafei H, Hillis GS. Preoperative neutrophil-lymphocyte ratio and outcome from coronary artery bypass grafting. Am Heart J. 2007 Nov;154(5):995-1002. doi: 10.1016/j.ahj.2007.06.043.
- 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.
KEZBAN MELTEM ÇOLAK principal investigator
Atatürk University, Faculty of Dentistry, Department of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Inferior Alveolar Nerve Block Failure, run by KEZBAN MELTEM ÇOLAK 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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Success Rate of Inferior Alveolar Nerve Block Anesthesia (time frame: Within 15 minutes after injection). 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 NCT07163065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.