Salivary Cytokine Profile as a Biomarker for Dental Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Dental Diseases
• Intervention / Treatment: Diagnostic test: Total Salivary Cytokine profile

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Riyadh Colleges of Dentistry and Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise of children with cerebral palsy(unable to verbalize pain) who have at least one dental condition that would be considered painful.

The sample will be matched to controls who have similar dental status and can verablize pain

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CP; A total of 20 children with cerebral palsy and dental decay will undergothe following Collection of Saliva Total Salivary Cytokine Profile	Diagnostic test: Total Salivary Cytokine profile; Saliva will be collected using the passive drool technique and stored in a deep freezerat-60C.; Other Names: cytokine profile
Control; A total of 20 verbal children without cerebral palsy matched for age and extent of dental decay will undergo the following Collection of Saliva Total Salivary Cytokine Profile	Diagnostic test: Total Salivary Cytokine profile; Saliva will be collected using the passive drool technique and stored in a deep freezerat-60C.; Other Names: cytokine profile

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Cytokine profile	Salivary IL1alpha in mcg, Salivary IL1beta in mcg, Salivary IL6 in mcg, IL8 in mc , Salivary TNFalpha in mcg	0 weeks (baseline)

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Investigators: Study Chair: Hezekiah A Mosadomi, DMD, Riyadh Elm University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: March 4, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (ACTUAL): March 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Stomatognathic Diseases
• Other Study ID Numbers: FPGRP/43635002/175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No