Salivary Cytokine Profile as a Biomarker for Dental Pain

NCT ID: NCT03471195

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy Dental Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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CP

A total of 20 children with cerebral palsy and dental decay will undergothe following Collection of Saliva Total Salivary Cytokine Profile

Total Salivary Cytokine profile

Intervention Type DIAGNOSTIC_TEST

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

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

Total Salivary Cytokine profile

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Total Salivary Cytokine profile

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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cytokine profile

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Dr Sharat Pani

Program Director Pediatric Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hezekiah A Mosadomi, DMD

Role: STUDY_CHAIR

Riyadh Elm University

Locations

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Riyadh Colleges of Dentistry and Pharmacy

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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FPGRP/43635002/175

Identifier Type: -

Identifier Source: org_study_id

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