Salivary Cytokine Profile as a Biomarker for Dental Pain

always reliable.Pain is an important diagnostic tool in dentistry. The type of treatment, extent of treatment and, sometimes, even the decision on whether to treat or not is dependent on the pain history obtained from the patient.The absence of an accurate description of dental pain is a factor that severely limits dental treatment planning in children with CP. The aim of this study is to study to evaluate the salivary cytokine profile of children with CP who have severe dental problems and to compare this to verbal children who have a similar dental profile.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Dental Diseases Nervous System Diseases Stomatognathic Diseases

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

About this study

The sample with CP will be selected from individuals attending the dental clinics of the Prince Sultan bin Abdulaziz Humanitarian city (SBAHC). The control patients will be selected from the dental clinics of the Riyadh Colleges of Dentistry and Pharmacy and be matched to the CP patients for age, gender and extent of dental problems. The sample will comprise of 20 patients with CP and 20 verbal controls.The oral health of all children will be recorded using WHO examination criteria .The teeth will be examined using WHO category II criteria - clinical examination with lighting and without radiographs.aliva will be collected from the children using the passive drool method and stored in sterile plastics collection tubes. The collected sample will be stored at -600C until they can be analyzed. The cytokine profile of the saliva sample will be analyzed using an ELISA kit for total cytokine profile (Luminex Performance Human Cytokine Panel A, LUH000, R&D systems) to measure cytokines IL-1 alpha, IL-1 beta, IL-8, and TNF-alpha. The pain perception of the verbal control group will be recorded using the validated Arabic version of the short form of the McGill Pain Questionnaire. The children will also indicate the extent of the pain using the Wong Baker Faces ™ pain perception scale.Normality of the total cytokine levels will be tested using the Shapiro-Wilkes Test. The Mann Whiney U test will be used to compare the cytokine profile the CP and control group. The spearman correlation will be used to explore the relationship between the reported pain and cytokine profile levels. If found to be significant an initial cytokine-pain map will be proposed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cerebral Palsy
At least one tooth with pulpal involvement
Aged between 8-12 years
No neurological illness (for Control Group)
Ability to verbalize pain (for Control Group)
One dental tooth with pulpal involvement matching the condition of the test group (for Control Group)

Exclusion criteria

confounding neurological disorders
History of orofacial pain syndromes
Absence of consent or assent

Treatment and study plan

Total Salivary Cytokine profile

Diagnostic Test

Saliva will be collected using the passive drool technique and stored in a deep freezerat-60C.

Other names: cytokine profile

Primary outcomes

Salivary Cytokine profile

Time frame: 0 weeks (baseline)

Salivary IL1alpha in mcg, Salivary IL1beta in mcg, Salivary IL6 in mcg, IL8 in mc , Salivary TNFalpha in mcg

Sponsors and collaborators

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy

Other

Registry information

Official study title

Salivary Cytokine Profile as Biomarker for Dental Pain in Children With Cerebral Palsy - An Exploratory Study

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Mar 20, 2018
Registry last updated: Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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