An observational study in Dental Pain, Pulpitis and Pulpal Inflammation, sponsored by Kahramanmaras Sutcu Imam University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Kahramanmaras Sutcu Imam University · Observational
This observational cross-sectional study is designed to evaluate pulpal and salivary levels of Substance P (SP) and Calcitonin Gene-Related Peptide (CGRP) in individuals with and without dental pain. The study aims to assess the associations between neuropeptide levels, pain severity, histopathological pulpal inflammation, and psychological status including depression, anxiety, and stress. By integrating biological and psychosocial parameters, this study seeks to contribute to a comprehensive understanding of the multifactorial nature of dental pain.
Dental pain is a multifactorial condition influenced by peripheral inflammatory processes, neurogenic mechanisms, and psychological factors. Neuropeptides such as Substance P (SP) and Calcitonin Gene-Related Peptide (CGRP) are known to play an important role in pain transmission and pulpal inflammatory responses. However, the invasive nature of pulpal sampling limits the routine clinical application of pulpal biomarkers, emphasizing the need to investigate non-invasive biological media such as saliva.
This observational cross-sectional study includes adult participants who require endodontic treatment and are categorized into painful and painless groups based on clinical examination and pain assessment using the Verbal Rating Scale (VRS). Pulp tissue samples are obtained during routine endodontic access procedures, and unstimulated saliva samples are collected before and after the clinical procedure. Levels of SP and CGRP in pulp and saliva samples are measured using enzyme-linked immunosorbent assay (ELISA).
Psychological status is evaluated using the Depression Anxiety Stress Scale-21 (DASS-21) to assess levels of depression, anxiety, and stress. Pulpal inflammation is evaluated through histopathological examination of pulp tissue samples using a semi-quantitative scoring system.
The primary objective of this study is to evaluate the relationship between dental pain and pulpal and salivary neuropeptide levels. Secondary objectives include assessing the associations between neuropeptides, psychological status, pain severity, and histopathological pulpal inflammation. The study is designed to provide descriptive and associative data without intervention, supporting a biopsychosocial framework for understanding dental pain and exploring the potential clinical relevance of salivary biomarkers.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's enrollment of 72 is below the median of 100 across 15 observational studies indexed under Toothache.
Browse Toothache studies →Kahramanmaras Sutcu Imam University is the lead sponsor of 198 studies on the registry; 40 are open to participants now.
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The study population consists of adult individuals aged 18 to 65 years who present to a university dental hospital and require endodontic treatment for permanent teeth. Participants include individuals with dental pain and individuals without dental pain, classified based on clinical examination and pain assessment. All participants are systemically healthy or have ASA physical status I or II and provide written informed consent prior to participation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants presenting with dental pain who require endodontic treatment and report pain based on clinical examination and Verbal Rating Scale assessment.
Participants without dental pain who require endodontic treatment and report no pain based on clinical examination and Verbal Rating Scale assessment.
Pulpal Calcitonin Gene-Related Peptide (CGRP) Concentration
Calcitonin Gene-Related Peptide (CGRP) concentration measured in pulpal tissue samples collected during routine endodontic access. CGRP levels are quantified using enzyme-linked immunosorbent assay (ELISA) and expressed as picograms per milligram of pulp tissue (pg/mg). Higher values indicate increased neurogenic activity and pulpal stress.
Time frame: Periprocedural (single assessment at the time of endodontic access)
Salivary Substance P (SP) Concentration - Baseline
Substance P (SP) concentration measured in unstimulated whole saliva samples collected before the clinical procedure. SP levels are analyzed using enzyme-linked immunosorbent assay (ELISA) and expressed as picograms per milliliter (pg/mL). Higher values indicate increased neurogenic and stress-related activity.
Time frame: Baseline (prior to clinical procedure)
Salivary Substance P (SP) Concentration - Periprocedural
Substance P (SP) concentration measured in unstimulated whole saliva samples collected immediately after the clinical procedure. SP levels are analyzed using enzyme-linked immunosorbent assay (ELISA) and expressed as picograms per milliliter (pg/mL). Higher values indicate increased neurogenic and stress-related activity.
Time frame: Periprocedural (immediately after the clinical procedure; single assessment)
Dental Pain Severity (Verbal Rating Scale - VRS)
Dental pain severity assessed using the Verbal Rating Scale (VRS) with the following categories: 0 = No pain 1. = Mild pain 2. = Moderate pain 3. = Severe pain The scale ranges from 0 to 3, with higher scores indicating greater pain severity.
Time frame: Baseline (at clinical examination prior to treatment)
Psychological Status - Depression Anxiety Stress Scale-21 (DASS-21)
Psychological status assessed using the Depression Anxiety Stress Scale-21 (DASS-21), consisting of three subscales: depression, anxiety, and stress. Each subscale score ranges from 0 to 42, with higher scores indicating worse psychological status.
Time frame: Baseline (at clinical examination prior to treatment)
Histopathological Pulpal Inflammation Score
Degree of pulpal inflammation assessed by histopathological examination of pulp tissue samples using a semi-quantitative scoring system: 0 = No inflammation 1. = Mild inflammation 2. = Moderate inflammation 3. = Severe inflammation Higher scores indicate greater inflammatory severity.
Time frame: Periprocedural (after pulp tissue collection during endodontic access)
Correlation Between Neuropeptide Levels and Psychological Parameters
Correlation analysis between: Pulpal CGRP concentration (pg/mg), Salivary Substance P concentration (pg/mL), and Psychological parameters (depression, anxiety, stress scores measured by DASS-21). Associations are evaluated using appropriate statistical correlation analyses. This outcome does not represent a new biological measurement but an analytical relationship between predefined outcomes.
Time frame: Baseline (single assessment during study participation)
Plan to share: No — De-identified individual participant data (IPD) will not be shared due to ethical restrictions, institutional policies, and the sensitive nature of biological and psychological data collected in this study.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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