Clinical trial NCT06526572: Pain Measured by NRS and EEG in Acute Pulpitis
Official title: Measuring Pain Perception in Patients With Symptomatic Acute Pulpitis and Resistant to Inferior Alveolar Nerve Block Using NRS and Brain Waves
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pulpitis
Keywords: Acute pulpits
Electroencephalography
Numerical rate scale
Inferior Alveolar Nerve Block
Lead sponsor: Cleveland Dental Institute
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults male or females aged \[18-50 years\], Clinically diagnosed with symptomatic acute pulpitis based on dental examination and radiographic findings. They are medically free. They are willing and able to provide informed consent to participate in the study. They are able to communicate effectively in the language used for study procedures.

Brief summary: The aim of the proposed study is to investigate and comprehensively understand pain perception in patients diagnosed with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB).

The study aims to achieve this by utilizing a dual approach that combines subjective self-reporting of pain intensity using the Numeric Rating Scale (NRS) with objective neurophysiological assessment through brain wave analysis using electroencephalography (EEG).

By integrating these two methods, the study seeks to explore potential correlations between self-reported pain scores and neural responses recorded through EEG, providing insights into the pain experience of this specific patient population.

Ultimately, the goal of the study is to enhance the understanding of pain perception mechanisms in individuals with symptomatic acute pulpitis resistant to IANB and potentially guide the development of more effective and personalized pain management strategies for these patients.


Eligibility criteria: Inclusion Criteria:

Adults aged \[18-50 years\]. Clinically diagnosed with symptomatic acute pulpitis based on dental examination and radiographic findings.

Demonstrates resistance to inferior alveolar nerve block (IANB). Willing and able to provide informed consent to participate in the study. Able to communicate effectively in the language used for study procedures.

Exclusion Criteria:

Individuals with known neurological or psychiatric disorders affecting pain perception.

Pregnant individuals or those breastfeeding at the time of the study. History of severe allergies or adverse reactions to local anesthetics or EEG gel.

Presence of significant medical conditions that may contraindicate dental procedures or EEG recordings.

Individuals taking medications that could significantly affect pain perception (e.g., strong analgesics, sedatives).

Any contraindications for dental procedures or EEG recordings as determined by the study's dental and medical professionals.

Inability to understand and follow study instructions.

Primary outcomes:
measure: Electroencephalography (EEG)
timeFrame: 3 months
measure: Numerical Rate Scale (NRS)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Dental Institute
state: Ohio
Study officials:
affiliation: CDI
name: Ahmed A hashem, PhD
role: STUDY_DIRECTOR
References: