CompletedNot Applicable

Evaluation of Pulpal and Salivary Neuropeptides in Dental Pain

Turkey (Türkiye)72 participantsStarted 2024-11-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18-65 years * ASA physical status I or II * Presence of permanent teeth requiring endodontic treatment * Ability to understand the study procedures and provide written informed consent * No use of analgesic medications within 24 hours prior to clinical assessment * No food or drink intake within 2 hours prior to saliva sampling Exclusion Criteria: * Periodontal disease (probing depth \>4 mm or bleeding on probing \>20%) * Systemic inflammatory, autoimmune, neuropathic, or chronic pain disorders * Acute infection, fever, or antibiotic use within the last 7 days * Pregnancy or lactation * Regular use of psychiatric medications (e.g., antidepressants, anxiolytics, antipsychotics, antiepileptics) * Tobacco use or alcohol consumption within the last 24 hours * Previous endodontic treatment or history of dental trauma in the study tooth * Systemic diseases that may affect neuropeptide levels (e.g., diabetes mellitus, thyroid disorders, renal or hepatic disease) * Use of medications affecting salivary flow

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pulpal Calcitonin Gene-Related Peptide (CGRP) Concentration

Timeframe: Periprocedural (single assessment at the time of endodontic access)

Salivary Substance P (SP) Concentration - Baseline

Timeframe: Baseline (prior to clinical procedure)

Salivary Substance P (SP) Concentration - Periprocedural

Timeframe: Periprocedural (immediately after the clinical procedure; single assessment)

Trial details

NCT IDNCT07330024

SponsorKahramanmaras Sutcu Imam University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Dental Pain trials