NCT07163065

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

September 1, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

Systemic Inflammatory Index (SII)Neutrophil-to-Lymphocyte Ratio (NLR)Dental AnesthesiaMandibular BlockEndodontic Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 15 minutes after injection

Study Arms (1)

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.

Procedure: Inferior Alveolar Nerve Block Anesthesia

Interventions

Standard inferior alveolar nerve block anesthesia performed with lidocaine and epinephrine for mandibular dental treatment. Success rate and postoperative pain outcomes will be recorded

Patients Undergoing Inferior Alveolar Nerve Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Faculty of Dentistry, Department of Endodontics

Erzurum, Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 36076952BACKGROUND
  • Gibson 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.

    PMID: 17967611BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples for hematological and inflammatory marker analysis.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • KEZBAN MELTEM ÇOLAK

    Atatürk University, Faculty of Dentistry, Department of Endodontics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Endodontics, Principal Investigator

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 9, 2025

Study Start

September 27, 2024

Primary Completion

November 1, 2024

Study Completion

October 15, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations