Salivary Cytokine Profile as a Biomarker for Dental Pain

• ClinicalTrials.gov Identifier: NCT03471195
• Recruitment Status: Completed
• First Posted: March 20, 2018
• Last Update Posted: July 23, 2018
• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Information provided by (Responsible Party): Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Cerebral Palsy; Dental Diseases	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 Design

• Study Type: Observational
• Actual Enrollment: 46 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Salivary Cytokine Profile as Biomarker for Dental Pain in Children With Cerebral Palsy - An Exploratory Study
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: June 1, 2018
• Actual Study Completion Date: July 1, 2018

Groups and Cohorts

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 Name: 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 Name: cytokine profile

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

Criteria

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

Contacts and Locations

Locations

Saudi Arabia

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

Sponsors and Collaborators

Riyadh Colleges of Dentistry and Pharmacy

Investigators

• Study Chair: Hezekiah A Mosadomi, DMD; Riyadh Elm University

More Information

• Responsible Party: Dr Sharat Pani, Program Director Pediatric Dentistry, Riyadh Colleges of Dentistry and Pharmacy
• ClinicalTrials.gov Identifier: NCT03471195
• Other Study ID Numbers: FPGRP/43635002/175
• First Posted: March 20, 2018
• Last Update Posted: July 23, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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