Salivary Cytokine Profile as a Biomarker for Dental Pain

NCT03471195 | Completed

• 1 other identifier: FPGRP/43635002/175
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Dental Diseases

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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

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

Interventions

Total Salivary Cytokine profile DIAGNOSTIC_TEST

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

Also known as: cytokine profile

CP; Control

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy; Stomatognathic Diseases

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hezekiah A Mosadomi, DMD

  Riyadh Elm University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director Pediatric Dentistry

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 20, 2018
• Study Start: January 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 23, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)